Gait Training in Acute Stroke: A Case Study and
Evidence-Based Literature Analysis
By:
Corinna Benjamin
Doctoral Candidate
University of New Mexico School of Medicine
Division of Physical Therapy
Class of 2015
Advisor:
Ron Andrews. P.T., Ph.D.
Printed Name of Advisor: __________________________
Signature: ______________________ Date: __________
Approved by the Division of Physical Therapy, School of
Medicine, and University of New Mexico in partial fulfillment of the
requirements for the degree of Doctor of Physical Therapy.
TABLE OF CONTENTS
PICO QUESTION ........................................................................................... 3
ABSTRACT .................................................................................................... 3
BACKGROUND AND PURPOSE ...................................................................... 4
CASE DESCRIPTION ...................................................................................... 7
EXAMINATION ................................................................................... 8
EVALUATION .................................................................................... 12
INTERVENTIONS ............................................................................... 15
OUTCOMES ...................................................................................... 16
EVIDENCE-BASED ANALYSIS ....................................................................... 17
METHODOLOGIES OF SEARCH ......................................................... 17
LIST OF ANALYZED STUDIES ............................................................. 22
ARTICLE SUMMARIES..……………………………………………………………………23
DISCUSSION ..................................................................................... 32
CONCLUSION/BOTTOM LINE............................................................ 34
REFERENCES............................................................................................... 37
APPENDIX A: ANALYSIS WORKSHEETS........................................................ 39
APPENDIX B: DIAGRAM OF SEARCH PROCESS…………………………………………..96
APPENDIX C: STUDY SUMMARIES TABLE…………………………………………………..97
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PICO QUESTION
In patients with acute stroke, which intervention or combination of interventions commonly cited in
available research is most effective in facilitating a more efficient, coordinated gait pattern?
ABSTRACT
Purpose: This case study and evidence-based analysis aims to determine which intervention or
combination of interventions commonly cited in available research is most effective in facilitating a more
efficient, coordinated gait pattern in patients with acute stroke.
Background: A stroke occurs when a blood vessel in the brain is blocked or bursts, causing damage to the
brain. Stroke is the second leading global cause of death and accounts for 11% of deaths worldwide. It is
the fourth leading cause of death in the United States, causing 1 in every 20 deaths. A person in the U.S.
experiences a stroke approximately every 40 seconds. Stroke continues to be a major cause of disability
and a very common diagnosis seen in physical therapy.2,6,11 It is currently controversial which physical
therapy interventions are most effective in the treatment of acute stroke and some therapists continue to
use interventions that studies have found to be ineffective. Many studies investigating acute stroke have
themselves been found to be underpowered, biased and misleading. Quality research in this area is
sparse and requires analysis to determine which interventions are safe and effective in the acute stroke
population.
Case Description: The patient selected for this case study and analysis, Mrs. M, was an 85-year-old
female who suffered a left cerebrovascular accident (CVA) in November. She was hospitalized 4 days,
admitted to a rehabilitation hospital in early December and to a skilled nursing facility in late December.
The patient presented with right hemiparesis, decreased muscle strength, right foot drop, impaired balance
and transfer abilities, limited overall mobility, an inefficient, uncoordinated gait, expressive and receptive
aphasia, fatigue, and confusion. In addition to right hemiparesis, she reported significant left flank pain
limiting function of her left side.
Outcomes: A review of current literature revealed that a combination of the specific interventions listed
below, tailored to each patient’s needs, can decrease deficits, increase independence and improve overall
outcomes for patients with acute stroke. However, integrating results of current studies focused in acute
stroke rehabilitation is challenging due to diverse patient demographics, study designs and outcome
measures, high risk of bias and variability. While more high-quality research is needed, current research
supports evidence that a customized, multi-intervention, holistic approach involving the following
interventions improves patient outcomes in acute stroke.
Discussion: The overall quality of current research in acute stroke rehabilitation is moderate with many
studies demonstrating questionable reliability, validity and generalizability. This analysis focused on higherlevel systematic reviews and meta-analyses of current stroke research to determine which intervention or
combination of interventions commonly cited in current stroke research is most effective in facilitating a
more efficient, coordinated gait in patients with acute stroke. This analysis found a general consensus that
an individualized, patient-centered combination of interventions tailored to each patient’s specific needs
including some or all of the following is most effective in stroke rehab. These specific interventions include:
therapeutic exercise, task-oriented training, biofeedback, gait training, balance training, constraint-induced
movement therapy, treatment of shoulder subluxation, electrical stimulation, transcutaneous electrical
nerve stimulation, therapeutic ultrasound, and acupuncture. In the moderate to higher-quality stroke
intervention studies that are currently available, these interventions have been shown to be affordable, safe
and often effective in the acute stroke population. More high-quality research is needed involving similar
stroke patient demographics, research designs, and outcome measures to further investigate intervention
effects and to determine consistent, accepted parameters and protocols for optimal acute stroke
rehabilitation.
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SECTION I: BACKGROUND AND PURPOSE
A stroke, or cerebrovascular accident (CVA), occurs when a blood vessel to part of the brain is
blocked (ischemic) or bursts (hemorrhagic), causing damage to the brain. According to the American Heart
Association’s 2015 stroke statistics, worldwide prevalence of stroke in 2010 was 33 million, with 16.9 million
people having a first-time stroke. Stroke is the second-leading global cause of death behind heart disease,
accounting for 11.13% of total deaths worldwide. It is the fourth leading cause of death in the United
States, causing 1 in every 20 deaths in the U.S and killing nearly 129,000 people a year. In the U.S, a
person experiences a stroke approximately once every 40 seconds and dies from a stroke about once
every four minutes. About 795,000 people have a stroke every year. Over the past 10 years, the death
rate has fallen about 35 percent and the number of stroke deaths has dropped about 21 percent; however,
stroke continues to be the leading preventable cause of long-term disability and a very common diagnosis
seen in physical therapy.2,4,6,11
While each stroke is different and effects depend on the part of the brain injured and the patient’s
overall health, stroke survivors often present with weakness (hemiparesis) or paralysis (hemiplegia),
usually affecting one side of the body or just an arm or leg. They often have difficulty controlling movement
(motor control), sensory disturbances including pain, problems using and/or understanding language
(aphasia), problems with thinking and memory, emotional disturbances, visual problems sleeping issues,
sexual dysfunction, seizures and fatigue. 3 Specifically, patients with left CVA frequently experience
weakness/paralysis of the right side of the body, speech/language problems, slow/cautious behavior and
memory loss. Right CVA survivors often experience weakness/paralysis on the left side of the body, vision
problems, quick, inquisitive behavior and memory loss. Stroke survivors also frequently have numbness,
stiffness, abnormal movement/patterning (synergies), fatigue and abnormal gait.3,13,14 Often after stroke,
people demonstrate an asymmetrical, inefficient, uncoordinated gait pattern that affects their endurance,
ability to perform ADLs, overall independence and safety, ability to return to prior level of function and
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overall quality of life. Research has shown that stroke patients can become deconditioned and debilitated
very quickly, leading to increased hospital stays, long-term health care needs and poorer outcomes.
Research has also shown that regaining function within the first year following a stroke is of critical
importance.1,4
Following hospitalization, stroke survivors are often transported to skilled nursing facilities (SNFs)
for rehabilitation. While the design of SNFs varies, they tend to be short-term health care facilities
providing 24-hour medical care and a variety of services including physical, occupational and speech
therapies. They accept patients with a wide range of diagnoses and conditions including trauma, surgery,
illness/disease, special needs, TIA/CVA, MI, and general decline in medical status. The diagnosis of CVA
is one of the most common diagnoses seen in the SNF setting. One of the most common physical therapy
goals stated by patients with CVAs is to be able to walk “normally” again, which makes gait training a
priority in stroke rehabilitation.
There are many physical therapy interventions that clinicians tend to use with post-stroke patients
including: neurodevelopmental treatment (NDT); proprioception neurodevelopmental facilitation (PNF);
passive, active assist, and active range of motion; bed mobility and transfer training; functional reaching
tasks; task-oriented training; overground and more recently bodyweight-supported and non-bodyweightsupported treadmill gait training; cardiorespiratory exercise; strengthening/resistance exercises, seated and
standing static/dynamic balance training; constraint-induced movement therapy; treatment of shoulder
subluxation; electrical stimulation; transcutaneous electrical nerve stimulation; biofeedback; therapeutic
ultrasound and acupuncture. However, it is currently unclear and controversial which interventions are
most effective in the treatment of acute stroke. Some therapists continue to use familiar interventions,
despite evidence indicating inefficacy and/or the availability of more effective, evidence-based treatments.
Meanwhile, many studies investigating acute stroke rehabilitation have themselves been found to be
underpowered, biased and misleading. Quality research in this area is sparse and needs to be analyzed, in
5
order to determine which interventions are safe and effective in the acute stroke patient population. New
quality research also needs to be performed to determine the best possible interventions, their effects and
optimal parameters.
The purpose of this analysis is to present one acute stroke patient’s case and to review current
literature in determining which interventions are most effective and safe in regaining gait function in the
acute stroke population. The specific Person Intervention Comparison Outcomes (PICO) question
examined in this article is, “In patients with acute stroke, which intervention or combination of interventions
is most effective in facilitating a more efficient, coordinated gait pattern?” The case study was an acute
stroke patient at a skilled nursing facility (SNF) from December to February following a left CVA.
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SECTION 2: CASE DESCRIPTION
Introduction
In December, an 85-year-old female was referred to a skilled nursing facility from a rehabilitation
hospital. The patient, Mrs. M., had experienced a left-sided ischemic CVA in late November while visiting
her daughter, resulting in right hemiparesis. Mrs. M had been hospitalized for 4 days immediately following
her stroke and was admitted to a rehabilitation hospital in early December. She was admitted to a SNF in
late December for a decline in medical status, including aspiration pneumonia, and in preparation for her
return home to Tucson, Arizona. Upon initial physical therapy evaluation at the SNF, the patient presented
with confusion, expressive and receptive aphasia, decreased upper and lower extremity strength (right
greater than left, right hemiparesis), right foot drop, impaired seated and standing static/dynamic balance,
impaired transfer abilities, limited overall mobility, decreased endurance and an inefficient, uncoordinated
gait. She reported that she had sustained a fall onto her right side during her stroke but had not incurred
significant injury. She also reported significant left flank pain, which limited function of her left side. The
patient was given PT diagnoses of hemiparesis and muscular weakness, an OT diagnosis of lack of
coordination, and speech diagnoses of severe expressive aphasia, mild receptive aphasia and dysphagia.
While residing at the SNF, Mrs. M received physical, occupational and speech therapies. Her
physical therapy included passive, active-assist and active upper extremity and lower extremity range of
motion (ROM); cardiovascular strengthening; upper extremity, lower extremity and core strengthening;
seated and standing static/dynamic balance and reaching activities; task-specific training; components of
neurodevelopmental treatment (NDT) and proprioceptive neurodevelopmental facilitation (PNF);
overground gait training (indoor and outdoor ambulation); bed mobility and transfer training (e.g., rolling,
scooting, sit to supine, supine to sit, sit to stand, stand to sit); stair training, car and curb transfers.
Electrical stimulation and treadmill training were never attempted with Mrs. M due to therapist preference
and familiarity with the applied interventions, despite the availability of an electrical stimulation machine.
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Treadmills were not available at this facility and a recumbent stepper was used instead. Mrs. M may have
been a good candidate for electrical stimulation and treadmill training due to her right foot drop and other
gait impairments. Mrs. M’s evaluation and much of Mrs. M’s physical therapy episode of care was provided
prior to this analysis.
EXAMINATION
Date of initial PT visit: Late December.
Admitting diagnosis: Left ischemic CVA.
History of current illness:
Patient is an 85-year-old female status post left ischemic CVA with right hemiparesis. Patient was
referred for stroke rehabilitation due to decline in medical status involving aspiration pneumonia and in
preparation for her return home to Arizona.
Onset date: Late November.
Past Medical History:
Hypercholesterolemia, DVT, PE, status post aspiration pneumonia, HTN, hypothyroidism,
hyperlipidemia, mitral valve replacement.
Past surgical history: Status post carpal tunnel surgery.
Prior level of function: Independent in all activities of daily living (ADLs), independent mobility, lived
alone, drove independently.
Social History:
Patient previously lived alone in a single-story home with 2 stairs to enter in Tucson, Arizona. Patient is
a retired schoolteacher. She had supportive family members in both Albuquerque and Tucson,
including 2 daughters in Albuquerque. Her husband died 28 years ago. She enjoyed walking,
gardening, reading, cooking/baking, entertaining and traveling with family and friends.
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Cognitive status:
Answered 1 out of 4 alertness and orientation questions correctly, difficult to assess cognition due to
expressive and receptive aphasia; followed commands accurately but demonstrated impairments in
working memory, attention/concentration, executive functions, problem solving, word finding,
awareness of medical condition and discrimination.
Primary Language: English
Communication barriers:
Severe expressive aphasia, moderate receptive aphasia, difficult and jumbled speech, impaired
cognition, frequent confusion.
Safety awareness:
Fair, frequently demonstrated impulsive behavior, limited safety awareness, limited short- and longterm memory for instructions and education regarding safety. Repeated verbal and tactile required.
Patient/family goals:
For patient to walk normally again, to return home to Tucson and to prior level of function, or to be as
independent as possible.
Discharge Plan:
Initially to return home with family and resume living alone in Arizona; however, patient was discharged
to a “very nice” skilled nursing facility near her home in Tucson for continued treatment to improve
independence and safety in activities of daily living.
Equipment:
Front-wheeled walker (patient already had a single point care, grab bars in restroom/shower/tub, and
shower chair). No prior history of falls. No oxygen demands.
Barriers to Discharge: Initially medical status and safety, but both improved.
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Systems Review:
Vitals: Temperature = 37.9°C, Blood Pressure= 138/79, Heart Rate = 76 bpm, Oxygen Saturation =
92% on room air.
General: Calm demeanor, demonstrating occasional confusion, difficult and jumbled speech.
Skin: Warm and well perfused, no rashes or evidence of skin breakdown.
HEENT: Normocephalic, atraumatic, normal reactive pupils bilaterally. Nares patent. Mucous
membranes moist.
Cardiovascular: Normal heart sounds, S1 and S2 normal.
Respiratory: Good air entry on room air. No wheezing or crackles noted.
Gastrointestinal: Slightly distended, soft. Normal bowel sounds.
Musculoskeletal: Edematous in dorsum of right hand and dorsal right foot.
Neurologic: Sensation absent in right L4-5 dermatome.
Neck: Supple.
Hematologic and lymphatic: No petechiae, active bleeding, normal lymph nodes.
FUNCTIONAL ASSESSMENT
Bed mobility: Minimal - moderate assistance.
o Rolling to left and right with stand-by assistance.
o Sit to supine with minimal - moderate assistance.
o Supine to sit with minimal assistance.
Transfers: Minimal – moderate assistance.
o Sit to stand from chair with minimal assistance.
o Sit to stand from bed with moderate assistance.
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o Stand to sit with minimal assistance, frequent verbal and tactile cues for safety and proper hand
placement required.
o Stand-pivot with minimal assistance.
Ambulation: Mrs. M ambulated 15 feet with 2-person bilateral hand-held moderate assistance. Gait
improved with front-wheeled walker, 20 feet with moderate assistance. Upon initiation of gait, patient
exhibited hesitancy, impaired muscle activation, impaired motor planning and balance deficits. She
demonstrated a flexed forward posture, right foot drop (“steppage gait”) and a significantly asymmetrical
gait involving a short step length during left swing-through phase and long step length during right swingthrough phase. She demonstrated reduced right heel strike and reduced weight acceptance onto the right
LE. She also demonstrated decreased rapid alternating/reciprocal movement of her right LE in accelerated
gait.
OBJECTIVE TESTS/MEASURES
Endurance: Fair, fatigued very quickly, frequent deep breathing cues required to maintain SpO2 above
90% during therapy sessions.
Posture: Mildly kyphotic.
Static sitting balance: Fair +
Dynamic sitting balance: Fair
Static standing balance: Fair
Dynamic standing balance: Fair –
Sensation: Light touch absent in right L4-5 dermatome.
Neuromuscular: Mild hypotonia noted in right UE and LE. Impaired coordination and motor planning of
right UE and LE, impaired bilateral gross and fine motor skills noted.
Pain: At Rest: 5/10
At Best: 4/10
At Worst: 9/10
Location: Left flank
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Active Range of Motion
Right UE AROM: Limited
Left UE AROM: Limited
Right LE AROM: Limited
Left LE AROM: Limited
Passive Range of Motion
Right UE ROM: WNL Right LE ROM: WNL
Left UE ROM: WNL
Left LE ROM: WNL
Manual Muscle Testing
UE Strength
(Note: AROM and MMT limited due to right hemiparesis and left flank pain)
Shoulder Flex
Shoulder Ext
Shoulder Abd
Shoulder Ext Rot
Elbow Flex
Elbow Ext
Grip
Right
3+/5
3+/5
3/5
3/5
3+/5
3+/5
3+/5
Left
4-/5
3+/5
3+/5
4/5
4/5
4/5
4/5
Plantarflex
3/5
4/5
Dorsiflex
3/5
4/5
LE Strength
Right
Left
Hip Flex
3/5
4-/5
Hip Ext
3/5
3+/5
Hip Abd
3/5
3+/5
Hip Ext Rot
3/5
4/5
Knee Flex
4-/5
4+/5
Knee Ext
3/5
4+/5
Trunk ROM/Strength: Fair. Patient demonstrated hesitancy and difficulty completing bilateral
sidebending onto elbows and return to midline, required minimal assist. Patient demonstrated difficulty with
trunk rotation and weight shifting in all planes.
Standardized Assessments:
o Timed Up and Go: 34.2 seconds with FWW and moderate assist.
o Tinetti Balance and Gait: 14/28, indicating high fall risk.
o Montreal Cognitive Assessment (MoCA) score: 9/23, indicating severe cognitive impairment.
EVALUATION
Medical Diagnosis: Left ischemic CVA. ICD-9 code 434.91. ICD-10 code I63.30.
PT Diagnoses:
o Right hemiparesis. ICD-9 code 438.21. ICD-10 code I69.951.
o Muscular weakness. ICD-9 code 728.87. ICD-10 code M62.81.
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Narrative Assessment: Mrs. M is an 85-year-old female who suffered a left ischemic CVA in November,
sustaining a fall onto her right side. Patient was hospitalized and then transferred to a rehabilitation
hospital on in early December for rehabilitation. She was admitted to a skilled nursing facility in late
December status post aspiration pneumonia for evaluation and treatment. Upon physical therapy
evaluation, Mrs. M presented with confusion, expressive and receptive aphasia, decreased upper and
lower extremity strength (right greater than left, right UE/LE hemiparesis), right foot drop, and deficits in
seated and standing balance, bed mobility and transfers, decreased endurance and impaired ambulation.
Patient reported significant left flank pain limiting function of her left side. Patient was a retired
schoolteacher previously independent in all ADLs and lived alone in a single-level home with 2 steps to
enter the home. She had good family support and good motivation for recovery. With skilled PT services,
Mrs. M returned to Tucson; however, she was discharged to another skilled nursing facility instead of her
home, per patient and family request and medical necessity.
Clinical Judgments and Problem List:
1) Decreased upper and lower extremity strength bilaterally (right greater than left, right hemiparesis).
2) Decreased ambulation distance.
3) Impaired gait pattern (right foot drop/steppage gait, altered/asymmetrical step length, inefficient,
uncoordinated gait).
4) Moderate A required for ambulation with front-wheeled walker.
5) Minimal-Moderate A for bed mobility.
6) Minimal-Moderate A for transfers.
7) Decreased seated and standing static/dynamic balance.
8) Decreased UE and LE coordination.
9) Fatigue/decreased endurance.
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10) Decreased body awareness and safety.
Prognosis: Patient had a good prognosis for stated goals.
Short Term Goals (2 weeks)
1) Patient will demonstrate 3 sit to stand transfers with supervision only, to increase mobility and
safety in home environment.
2) Patient will ambulate 50 feet with FWW with supervision on even surfaces, to improve mobility and
ADLs.
3) Patient will perform 2 supine to sit transfer to both right and left sides with supervision, to improve
bed mobility.
4) Patient will tolerate 60 consecutive minutes of therapeutic activities for improved ADL performance.
5) Patient will demonstrate gross right LE strength improvement of 1 strength grade to improve
transfers, gait mechanics and functional mobility.
6) Patient will score ≥ 20 on the Tinetti Balance and Gait Assessment to reduce the risk of falls.
Long-Term Goals (4 weeks)
1) Patient will be modified independent or independent with bed mobility for increased independence
in the home environment.
2) Patient will be modified independent or independent in all transfers for improved mobility and safety
in home environment.
3) Patient will ambulate 500 feet with least restrictive device (LRD) with supervision, demonstrating
limited steppage gait on even and uneven surfaces for reintegration into the community.
4) Patient will be Mod I in curb transfers for mobility and safety in the community.
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5) Patient will demonstrate a car transfer independently with family for safe discharge home to
Tucson.
6) Patient will be independent in home exercise program for continued strengthening at home.
Plan of Care
PT Frequency and Duration: 5-7 times per week for 4 weeks: 1 hour of PT, 1 hour of OT and 1 hour of
speech therapy daily.
Coordination and Communication with Other Health Professionals:
o OT, SLP, dietician, physician, nursing, social worker and discharge planner.
Direct Interventions:
o Patient and family education in caregiving, ADLs, available resources, stairs, car/curb transfers,
and home exercise program.
o Passive, active-assist and active bilateral upper extremity and lower extremity ROM exercises.
o Upper and lower extremity and core strengthening exercises with and without weights in standing,
sitting, supine and side-lying.
o Cardiovascular strengthening and reciprocal movement exercises including NuStep recumbent
stepper, arm ergometer and stationary bicycle, increasing resistance and duration as tolerated.
o Seated and standing static/dynamic balance and reaching activities, increasing difficulty and
duration as tolerated.
o Functional mobility, task-specific and ADL training (e.g., obstacle courses involving various ADL
and mobility tasks: picking up and placing objects on surfaces of varying heights, reaching into
high/low cabinets, ascending/descending stairs, stepping onto and over objects, dressing in
sitting/standing, stepping in various patterns/directions/speeds).
15
o Components of neurodevelopmental treatment (NDT) (e.g., supine, prone, sitting and standing
balance and reaching activities, weight shifting and weight acceptance onto right LE,
kicking/tossing/rolling a ball, gait training).
o Components of proprioceptive neurodevelopmental facilitation (PNF) (e.g., symmetrical and
asymmetrical D1 and D2 patterns, chop, lift, rhythmic stabilization, muscle initiation/activation,
contract/relax, alternating isometrics).
o Overground gait training (indoor and outdoor ambulation on even/uneven terrain) with focus on
increased balance, step length symmetry, decreased right steppage gait, upright posture,
breathing, pacing/energy conservation.
o Bed mobility and transfer training (e.g., rolling, scooting, sit to supine, supine to sit, sit to stand and
stand to sit from bed, chairs and mats of varied elevations, sitting EOB, bed to chair).
o Stair training with and without FWW.
o Car and curb transfers.
o Patient progressed as tolerated with decreased assistance.
Discharge Plan: Patient’s initial discharge plan was home with family to resume living alone at her home
in Tucson, Arizona.
OUTCOMES
Mrs. M made good progress during her stay at Advanced Health Care. Per patient and family request and
medical necessity, she was discharged on January 16, 2015 to the care of her daughter and transferred to
another skilled nursing facility in Tucson, AZ for continued medical care and therapies. Patient was
discharged having met and partially met all of her PT goals. Upon PT evaluation, patient was ambulating
only 20 feet with FWW and Mod A, demonstrating right foot drop, significantly asymmetrical step length,
limited right LE weight acceptance and balance deficits. On day of discharge, she was ambulating 250 feet
16
with a FWW and Contact Guard Assist (CGA) with minimal right foot drop, improved gait step symmetry
and improved balance, especially when forced to increase speed for more automatic gait. However, patient
regressed to very long right LE stride length when fatigued. Patient had also improved in bed mobility and
transfers; however, continued to need Stand By Assist (SBA) for bed mobility and CGA for transfers for
stability and safety. She continued to have difficulty recalling safe technique with all mobility skills,
particularly with transfers and hand placement. She would be receiving continued PT at the SNF in Tucson
to improve independence and safety in ADLs, strength, balance and gait pattern. Patient was discharged
with a front-wheeled walker with 5-inch wheels.
Outcome Assessments at Discharge:
o Timed Up and Go
o Initial evaluation: 34.2 seconds with FWW and Mod A.
o Discharge: 17.4 seconds with FWW and CGA.
o Tinetti Balance and Gait
o Initial evaluation: 14/28, indicating high fall risk.
o Discharge: 19/28, indicating moderate fall risk.
SECTION 3: EVIDENCE-BASED ANALYSIS
Methodologies of Search
The purpose of this analysis was to answer the PICO question: “In patients with acute stroke,
which intervention or combination of interventions most commonly cited in available research and detailed
in this analysis is most effective in facilitating a more efficient, coordinated gait pattern?” In order to identify
all relevant articles, the major digital databases were searched, including PubMed, Physiotherapy Evidence
Database (PEDro), Cumulative Index to Nursing and Allied Health Literature (CINAHL), The Cochrane
Library, and Web of Science. Keywords and MeSH terms included: “Gait Training Acute Stroke,” “Stroke
17
and Ambulation,” “Stroke and Physical Therapy and Gait Training,” Gait Training Post Stroke.” Limits and
filters included human subjects, articles no more than 10 years old, peer reviewed, systematic reviews,
meta-analyses, practice guidelines, PDF full text available, and English language.
PubMed
The main search of PubMed yielded a total of 362 results. Three hundred thirty-two articles were excluded
by title review based on relevance, languages other than English, duplicate articles, and/or low level of
evidence. Nineteen articles were excluded due to a topic/subjects not closely related to the case study or
subject material and age, being published greater than ten years prior to 2015. Nine articles were then
excluded due to poor study/review design, low level of evidence, high potential for bias and/or not being
closely related to the case study or P.I.C.O. question. This left two articles for abstract review, both of
which were determined appropriate for in-depth analysis. Refer to PubMed search in Appendix C: Diagram
of Search Process.
PubMed Search
o Combinations of keywords and MeSH terms: “Gait Training Acute Stroke,” “Stroke and
Ambulation,” “Stroke and Physical Therapy and Gait Training,” Gait Training Post Stroke”) = 362
articles total.
o Title review and exclusion based on duplication, publication age more than 10 years, low level of
evidence, poor design, low relevance to topic/case study = 30 articles.
o With 6 limits (Humans, no more than 10 years old, peer reviewed, systematic reviews, metaanalysis, practice guideline, systematic reviews) = 11 articles.
o Articles determined appropriate for in-depth analysis = 2 articles (Brosseau, Eng).
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CINAHL
The main search of CINAHL yielded a total of 157 results. One hundred forty-two articles were excluded by
title review, irrelevance, languages other than English, duplicate articles with other databases, low level of
evidence, topic/subjects not closely related to the case study or subject material. Ten articles were
excluded for being more than 10 years old, low level of evidence, poor study/review design and/or not
being closely related to the case study or P.I.C.O. question. This left one article for abstract review, which
was determined appropriate for in-depth analysis. Refer to CINAHL search in Appendix C: Diagram of
Search Process.
CINAHL Search
o Keyword search: “Gait Training Acute Stroke,” “Stroke and Ambulation,” “Stroke and Physical
Therapy and Gait Training,” Gait Training Post Stroke” = 157 articles.
o With 7 limits (Find all search terms, full text, published 2005-2015, English language, peer
reviewed, human, PDF full text) = 15 articles.
o Exclusion based on duplication, publication age more than 10 years, low level of evidence, poor
design, low relevance to topic/case study = 5 articles.
o Articles determined appropriate for in-depth analysis = 1 article (Kafri).
Cochrane
A search of Cochrane yielded a total of 68 results. Sixty-two articles were excluded by title review,
irrelevance, languages other than English, duplicate articles with other databases, low level of evidence,
topic/subjects not closely related to the case study or subject material, publication age more than 10 years
old, low level of evidence, poor study/review design and/or not being closely related to the case study or
P.I.C.O. question. This left 6 articles for abstract review, 2 of which were determined appropriate for in-
19
depth analysis. Refer to Cochrane search in Appendix C: Diagram of Search Process.
Cochrane Search
o Keyword search: “Gait Training Acute Stroke,” “Stroke and Ambulation,” “Stroke and Physical
Therapy and Gait Training,” Gait Training Post Stroke” with 1 limit (reviews) = 68 articles.
o Exclusion based on duplication, publication age more than 10 years, low level of evidence, poor
design, low relevance to topic/case study = 6 articles.
o Articles determined appropriate for in-depth analysis = 2 articles (Mehrholz, Saunders).
PEDro
The main search of PEDro yielded a total of 76 results. Fifty-seven articles were excluded by title review,
irrelevance, languages other than English, duplicate articles, and/or low level of evidence. Sixteen articles
were excluded due to duplication with articles from other databases, relevance, publication age, and low
level of evidence. This left 2 articles for abstract review, both of which were determined appropriate for indepth analysis. Refer to PEDro search in Figure 1.
PEDro Search
o Keyword search: “Gait Training Acute Stroke,” “Stroke and Ambulation,” “Stroke and Physical
Therapy and Gait Training,” Gait Training Post Stroke” = 76 articles.
o With 2 limits (systematic reviews, practice guidelines) and exclusion based on duplication,
publication age more than 10 years, low level of evidence, poor design, low relevance to topic/case
study = 3 articles.
o Articles determined appropriate for in-depth analysis = 2 articles (Hollands, Zijlstra).
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Web of Science
A search of Web of Science yielded 229 total results. Two hundred thirteen articles were excluded by title
review, irrelevance, duplication, languages other than English, publication age and low level of evidence.
Thirteen articles were excluded due to a topic/subjects not closely related to the case study or subject
material. This left 3 articles for abstract review, 1 of which was determined appropriate for in-depth
analysis. Refer to Web of Science search in Appendix C: Diagram of Search Process.
Web of Science Search
o Keywords search: “Gait Training Acute Stroke,” “Stroke and Ambulation,” “Stroke and Physical
Therapy and Gait Training,” Gait Training Post Stroke” = 229 articles.
o With 5 limits (Rehabilitation, neurosciences/neurology, reviews, 2005-2015, English) = 16 articles.
o Exclusion based on duplication, publication age more than 10 years, low level of evidence, poor
design, low relevance to topic/case study = 3 articles.
o Articles determined appropriate for in-depth analysis = 1 articles (Stoller).
Additional Searches: Searches were also performed in which reference lists, “grey literature” and other
databases (Science Direct, SPORT Discus) where examined; however, no articles were found with higherlevel evidence or more relevancy than those stated above.
21
Analyzed Articles:
Reference #1: Brosseau L, Wells GA, Finestone HM, et al. Ottawa panel evidence-based clinical
practice guidelines for post-stroke rehabilitation. Top Stroke Rehabil. 2006; 13(2): 1-269.
Reference #4: Eng JJ, Tang PF. Gait training strategies to optimize walking ability in people with
stroke: A synthesis of the evidence. Expert Rev Neurother. 2007; 7(10): 1417-1436.
doi:10.1586/14737175.7.10.1417.
Reference #5: Hollands KL, Pelton TA, Tyson SF, Hollands MA, van Vliet PM. Interventions for
coordination of walking following stroke: Systematic review. Cochrane Database of Systematic
Reviews. 2012; 35(3): 349-359.
Reference #7: Kafri M, Laufer Y. Therapeutic effects of functional electrical stimulation on gait in
individuals post-stroke. Ann of Biomed Engin. 2015; 43(2): 451–466. doi: 10.1007/s10439-014-1148-8.
Reference #9: Mehrholz J, Elsner B, Werner C, Kugler J, Pohl M. Electromechanical-assisted training
for walking after stroke. Cochrane Database of Systematic Reviews. 2013; 7(Art. No. CD006185):1100. doi: 10.1002/14651858.CD006185.pub3.
Reference #15: Saunders DH, Sanderson M, Brazzelli M, Greig CA, Mead GE. Physical fitness training
for stroke patients. Cochrane Database of Systematic Reviews. 2013; 10(Art. No. CD003316). doi:
10.1002/14651858.CD003316.pub5.
Reference #17: Stoller O, de Bruin ED, Knols R, Hunt KJ. Effects of cardiovascular exercise early after
stroke: systematic review and meta-analysis. BMC Neurology. 2012; 12(45): 1-16.
Reference #20: Zijlstra A, Mancini M, Chiari L, Zijlstra W. Biofeedback for training balance and mobility
tasks in older populations: A systematic review. J Neuroeng Rehab. 2010; 7(58). doi:10.1186/17430003-7-58.
22
ARTICLE SUMMARIES
Reference #1:
Brosseau L, Wells GA, Finestone HM, et al. Ottawa panel evidence-based clinical practice guidelines for
post-stroke rehabilitation. Top Stroke Rehabil. 2006; 13(2): 1-269.
Level of Evidence: 2a, Pedro N/A
Purpose: The purpose of this systematic review and meta-analysis was to create guidelines for 13 types of
physical rehabilitation interventions used in the management of adult patients (>18 years old) presenting
with hemiplegia or hemiparesis following a single clinically-identifiable ischemic or hemorrhagic
cerebrovascular accident (CVA). The purpose of developing these guidelines was to promote the
appropriate use of various physical rehabilitation interventions in the management of stroke survivors.
Methods: In addition to the Ottawa Methods Group (OMG), a panel of multidisciplinary experts was
selected to methodologically develop high-quality clinical practice guidelines for stroke rehabilitation. The
library scientist developed a structured literature search based on the sensitive search strategy
recommended by The Cochrane Collaboration and modifications to that strategy proposed by Haynes et al.
She searched the electronic databases of MEDLINE, EMBASE, Current Contents, CINAHL, PEDro, the
Cochrane controlled Trials Register, the Cochrane Field of Rehabilitation and Related Therapies, the
Cochrane Musculoskeletal Group, and the University of Ottawa EBCPGs website. The reference lists of all
of the included trials were also searched for relevant studies and content experts were contacted for
additional studies or “grey literature.” Of the 1533 articles initially identified as relevant, 261 met inclusion
criteria and were included in the analysis. The panel then selected, analyzed and rated the evidence by
level and strength of evidence to develop the Ottawa guidelines.
Results: Two hundred sixty-one studies were included for this review. The studies were categorized into
two groups based on the outcome addressed: therapeutic exercises, task-oriented training, biofeedback,
gait training, balance training, sensory interventions, constraint-induced movement therapy (CIMT),
treatment of subluxation, electrotherapy, electrical stimulation, TENS, therapeutic ultrasound, acupuncture,
intensity and organization of rehabilitation. The range of level of evidence was 1b to 3b. Ultimately, the
Ottawa Panel graded and recommended the use of many interventions: therapeutic exercise, task-oriented
training, biofeedback, gait training, balance training, CIMT, treatment of shoulder subluxation, electrical
stimulation, transcutaneous electrical nerve stimulation, therapeutic ultrasound, acupuncture, and intensity
and organization of rehabilitation in the management of post stroke.
Critique/Bottom line: This study systematically reviewed and rated literature examining the efficacy and
safety of various interventions in post-stroke rehabilitation. This was a comprehensive literature review and,
although the authors lowered the SR’s level of evidence by including studies other than RCTs, the SR and
CPGs were well researched and did a good job of considering clinical significance in addition to statistical
significance and grading the evidence and interventions accordingly. The evidence, grading and CPGs are
easy to follow and provide a nice, evidence-based foundation for therapists considering various
interventions for the post-stroke population.
23
Reference #4:
Eng JJ, Tang PF. Gait training strategies to optimize walking ability in people with stroke: A synthesis of the
evidence. Expert Rev Neurother. 2007; 7(10): 1417-1436. doi:10.1586/14737175.7.10.1417.
Level of Evidence: 2a, Pedro N/A
Purpose: The purpose of this systematic review and meta-analysis was to examine common gait training
strategies (neurodevelopmental techniques, muscle strengthening, treadmill training, intensive mobility
exercises) to improve walking ability in people after stroke. The results from randomized controlled trials
are presented and implications for optimal gait training strategies are discussed.
Methods: A keyword search using Medline, CINAHL, and Cochrane Collaboration was performed using the
terms gait, locomotion, walking, ambulation combined with stroke or cerebrovascular disease (CVA). In
addition, hand searching of references from these articles was performed. Primary importance was placed
on recent meta-analyses and systematic reviews if they were available. Individual randomized controlled
trials (RCTs) were also assessed. For areas with multiple RCTs where current meta-analyses were not
available, a pooled standardized effect size with confidence intervals (CI) was constructed across trials.
Results: Of the 39 articles included, 7 investigated neurodevelopmental techniques, 5 examined strength
training, 17 examined task-specific training (i.e., treadmill) and 10 examined intensive mobility training. Nine
articles were systematic reviews or meta-analyses that included gait outcomes. The general consensus of
this article was that: 1) neurodevelopmental approaches were equivalent or inferior to other approaches to
improve walking ability, 2) graded muscle strengthening (not using functional activities) improves muscle
strength, but does not transfer to improved walking ability, 3) treadmill training had equivalent effects to
overground gait training in sub-acute rehabilitation and beneficial effects compared to low intensity control
groups in chronic stroke, 4) a combination of treadmill with task-specific practice may be optimal, 5)
intensive mobility training which incorporates functional strengthening, balance and aerobic exercises and
practice on a variety of walking tasks improves gait ability both in sub-acute and chronic stroke.
Critique/Bottom line: This is a well-done SR and meta-analysis examining available literature for gait
training strategies to optimize walking ability in people with stroke. Much of the research on this topic tends
to be of low to moderate quality, bias is common and outcome measures tend to be diverse and difficult to
pool; however, the researchers did a good job of identifying a good body of evidence to perform a SR and
meta-analysis. Further research is needed in this area and should include large RCTs and multi-site
collaborations with larger sample sizes, long-term follow-up of walking ability, evaluation of important
secondary complications (e.g., falls, fractures, heart disease and recurrence of stroke) and common
outcome measures (e.g., gait speed, 6-minute walk test) and potentially new outcome measures relevant to
walking abilities. Future research should also investigate mechanisms that contribute to ambulation gains
(e.g., brain plasticity, postural control, aerobic, strengthening), as well as quantify the dose and intensity of
training (e.g., using accelerometers, step counters and heart rate monitors).
24
Reference #5:
Hollands KL, Pelton TA, Tyson SF, Hollands MA, van Vliet PM. Interventions for coordination of walking
following stroke: Systematic review. Cochrane Database of Systematic Reviews. 2012; 35(3): 349-359.
Level of Evidence: 3a, Pedro N/A
Purpose: The purpose of this systematic review and meta-analysis was to examine all current non-surgical
and non-pharmacological rehabilitation interventions that treat gait coordination impairments in stroke
survivors, their effects on gait coordination and overall walking ability and their theoretical basis. This
facilitated an examination of the hypothesis that restoration of a coordinated gait pattern is a mechanism to
improve overall walking ability. The authors also sought to identify gaps in the current knowledge base,
directions for future research and promising interventions for further study.
Methods: The authors searched electronic databases including the Cochrane Stroke Group Trials Register,
Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE,
CINAHL, AMED, National Institutes of Health (NIH) Clinical Trials Database host: NIH, National Institute of
Clinical Studies. Rehabilitation-specific databases were searched including OTseeker, OT Search, PEDro,
Chartered Society of Physiotherapy Research Database, and REHABDATA. They used controlled
vocabulary (MeSH) and free text terms, and limits including English papers with human participants.
Results: The search strategy initially identified 1132 titles, of which 33 studies involving 9 RCTs and 556
participants were selected. The range of evidence was Oxford 1b to 3b. When combined, the interventions
had a moderate, positive effect on gait coordination. However, only auditory cueing showed a significantly
positive (in that the participants’ gait became more symmetrical) effect when the different types of
intervention were considered individually. Exercise showed a non-significant negative effect, in that the
patient’s gait became less symmetrical during or after the intervention. Overall, the interventions showed
significant improvements on gait speed. Each type of intervention also showed a positive effect. Auditory
cueing showed the greatest effect, task specific practice and exercise had small but positive effects, while
orthoses and FES produced the least change.
Critique/Bottom Line: Although these results appear to be very positive and to favor treatment, they must
be interpreted with caution and should not be considered definitive evidence of effectiveness. The results
indicate that interventions involving auditory cueing and task-specific practice of walking may positively
influence gait coordination after stroke. They also found that overall improvements in gait coordination
coincided with increased walking speed, lending support to the hypothesis that interventions targeting lower
limb coordination may be a mechanism to improve walking for some people with stroke. These are
relatively affordable and safe interventions that have some evidence of effectiveness and may be beneficial
to some stroke patients; however, further research and future high-quality studies are needed.
25
Reference #7:
Kafri M, Laufer Y. Therapeutic effects of functional electrical stimulation on gait in individuals post-stroke.
Ann of Biomed Engin. 2015; 43(2): 451–466. doi: 10.1007/s10439-014-1148-8.
Level of Evidence: 2a, Pedro N/A
Purpose: The purpose of this systematic review was to systematically present and critically review reported
therapeutic benefits in regard to body function (e.g., muscle strength and tone) and mobility-related
activities (e.g., gait speed) associated with lower extremity (LE) functional electrical stimulation (FES) in
individuals post-stroke.
Methods: The authors searched the electronic databases PubMed, CINAHL, PEDro, and Scopus with the
last full search conducted in July 2014. The electronic search was completed by a hand search of
bibliographic references of the included studies. The search terms used were [functional electrical
stimulation OR neuromuscular electrical stimulation] AND [stroke OR hemiparesis OR cerebrovascular
accident] AND [gait OR walking OR locomotion]. The search was restricted to peer-reviewed clinical trials,
the English language, PEDro score greater than 4, greater than 10 participants, inferential statistics. The
titles and abstracts of all identified articles were reviewed and the full article was read to finalize decisions
regarding inclusion. The authors independently reviewed and rated the level of evidence of each study
using the PEDro scale.
Results: Sixteen studies met inclusion criteria for review. Fourteen of the 16 studies were RCTs. The
authors found moderate but clinically significant evidence that FES technology has the potential to promote
gait performance and other aspects of LE motor recovery after stroke. The methodological quality of the
included studies ranged from 4 to 8 on the PEDro scale. Two studies scored 4, four studies scored 5; five
studies scored 6; four studies scored 7 and one study scored 8. Nine studies received a PEDro score in the
‘good’ range and six in the ‘fair’ range, with only the study by Ambrosini et al. rated as ‘excellent.’ Overall,
the studies appeared to have similar/consistent results. Therapeutic effects of FES were demonstrated at
the body function and activity levels when used as a training modality.
Critique/Bottom Line: FES is a relatively safe, affordable intervention that, when applied to tibialis anterior
muscles, has been shown to increase motor evoked potentials, especially when coupled with voluntary
movement. Interestingly, fMRI studies have demonstrated that voluntary movement together with electrical
stimulation was associated with increased brain activity and changes in the primary motor cortex, the
primary and secondary somatosensory cortices, the sensorimotor cortex, and the cerebellum, as well as
with increased coupling between specific brain regions. There is also some evidence that treadmill training
with FES can influence brain plasticity with some lasting effects. Further well-controlled studies are
warranted to substantiate these findings and to further evaluate the therapeutic effects of FES.
26
Reference #9:
Mehrholz J, Elsner B, Werner C, Kugler J, Pohl M. Electromechanical-assisted training for walking after
stroke. Cochrane Database of Systematic Reviews. 2013; 7(Art. No. CD006185): 1-100. doi:
10.1002/14651858.CD006185.pub3.
Level of Evidence: 2a, Pedro N/A
Purpose: The purpose of this systematic review was to update a previous review performed by the same
authors in 2007 investigating the effects of automated electromechanical and robotic-assisted gait training
devices for improving walking after stroke. The authors’ aim was to estimate the likelihood or chance of
becoming independent in walking as the result of these interventions, which is a main rehabilitation goal for
patients after stroke.
Methods: Two review authors independently selected trials for inclusion, assessed methodological quality
and extracted the data. The authors utilized multiple databases including the Cochrane Stroke Group Trials
Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL,
AMED, SPORTDiscus, the Physiotherapy Evidence Database (PEDro), and the engineering databases
COMPENDEX and INSPEC. They also hand searched relevant conference proceedings, searched trials
and research registers, checked reference lists and contacted authors to identify ‘grey’ literature or further
published, unpublished and ongoing trials. The MeSH terms used were Orthotic Devices; Walking;
Combined Modality Therapy; Equipment Design; Exercise Therapy; Gait; Randomized Controlled Trials as
Topic; Robotics; Stroke; and Humans. Searches of the electronic databases and of trials registers
generated 4747 unique references for screening. After excluding non-relevant citations, the authors
obtained the full text of 136 papers and included 23 trials in the review.
Results: Twenty-three studies were included for this review. The results of this SR indicated that
electromechanical-assisted gait training in combination with conventional physical therapy increases the
odds of acute, non-ambulatory stroke patients becoming independent in walking after stroke. Specifically,
people in the first three months after stroke and those who are unable to walk at intervention onset seem to
benefit the most from this type of intervention. Results indicate that people in the chronic phase of stroke (3
months post) may not benefit from electromechanical-assisted gait training. Electromechanical gait training
did not significantly increase walking velocity or walking capacity.
Critique/Bottom Line: These SR results should be interpreted with caution because (1) some trials
investigated people who were independent in walking at the start of the study, (2) variations were found
between the trials with respect to devices used and duration and frequency of treatment, and (3) some
trials included devices with functional electrical stimulation.
Given that necessary equipment, therapist skill set, time and third party coverage are available, evidence
suggests that electromechanical-assisted gait training may be a promising adjunct to conventional physical
therapy and alternative to overground gait training with a low risk of adverse events. Further research is
needed and should consist of large, definitive, pragmatic, phase III trials to address the frequency and
duration of electromechanical-assisted gait training that might be most effective and how long the benefit
might last.
27
Reference #15:
Saunders DH, Sanderson M, Brazzelli M, Greig CA, Mead GE. Physical fitness training for stroke patients.
Cochrane Database of Systematic Reviews. 2013; 10(Art. No. CD003316). doi:
10.1002/14651858.CD003316.pub5.
Level of Evidence: 2a, Pedro N/A
Purpose: This systematic review and meta-analysis is an update to a previous SR by the same authors.
The purpose was to determine whether fitness training after stroke reduces death, dependence, and
disability. The secondary aims were to determine the effects of training on physical fitness, mobility (gait
speed and capacity), physical function, health status and quality of life, mood, and incidence of adverse
events.
Methods: The authors searched electronic databases including the Cochrane Stroke Group Trials Register,
Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, SPORTDiscus,
Science Citation Index Expanded, Web of Science, PEDro, REHABDATA, Index to Theses in Great Britain
and Ireland, Internet Stroke Centre’s Stroke Trials Directory database, metaRegister of Controlled Trials,
Internet Stroke Centre’s website, European Stroke Conference, International Stroke Conference and the
World Stroke Conference. The also handsearched relevant scientific journals focused on exercise and
physical fitness and are not currently included in The Cochrane Collaboration handsearching program
including Adapted Physical Activity Quarterly, British Journal of Sports Medicine, International Journal of
Sports Medicine, Journal of Science and Medicine in Sport, Research Quarterly for Exercise and Sport,
Sports Medicine. They examined the references lists of all relevant studies and further trials identified in
relevant systematic reviews. They checked all the references in both the studies awaiting classification and
ongoing studies sections of the previous version of this review. They also contacted experts in the field and
principal investigators of relevant studies to inquire about “grey literature,” unpublished and ongoing trials.
Results: All included studies (n = 45) reported that randomization had occurred; however, many of the
studies did not describe the specific mechanisms of randomization. Most of the included studies were of
moderate quality. Cardiorespiratory training involving walking appeared to improve maximum walking
speed, preferred gait speed, walking capacity, and Berg Balance scores after intervention. Mixed training
involving walking and resistance training appeared to increase preferred walking speed, walking capacity
and pooled balance scores but the evidence was weaker. Some mobility benefits persisted after follow-up.
Critique/Bottom Line: Although there appears to be a trend toward improvement with the interventions of
cardiorespiratory training and mixed training, these results must be interpreted with caution and good
clinical reasoning. Assessment suggested some potential for bias as the variability and quality of trials
indicated limited reliability and generalizability of the observed results. According to the authors, although
enough evidence is available to implement fitness training for stroke, the optimal exercise prescription has
yet to be defined. Future well-designed trials are needed to determine the optimal content of the exercise
prescription and identify long-term benefits.
28
Reference #17:
Stoller O, de Bruin ED, Knols R, Hunt KJ. Effects of cardiovascular exercise early after stroke: systematic
review and meta-analysis. BMC Neurology. 2012; 12(45): 1-16.
Level of Evidence: 2a, Pedro N/A
Purpose: The purpose of this SR was to evaluate the effectiveness of cardiovascular exercise (CV) early
after stroke and to provide an overview of the currently available evidence for the use of CV training in the
early stages after stroke. The aim is to identify strategies that have the potential to affect physical
functioning and that might be used in future early intervention type studies for individuals with stroke. The
following specific questions were evaluated: (1) What is the level of evidence for cardiovascular exercise
interventions to influence aerobic capacity and physical functioning implemented within six months after the
initial stroke event?; (2) How soon after the initial stroke event is cardiovascular exercise introduced?; (3)
What is the common practice for measurement of aerobic capacity early after stroke?
Methods: The authors searched the databases Medline/Premedline (OvidSP), EMBASE, Cochrane Library,
CINAHL, and Web of Science. They performed an additional focused search in which “stroke” had to be in
the title or subject headings. Combinations of MeSH and keywords included: Stroke, Cerebral Stroke,
Vascular Accident, Brain Vascular Accident, Apoplexy, Cerebrovascular Apoplexy, Cerebrovascular Stroke,
CVA, Cerebrovascular Accident, Acute Stroke, Acute Cerebrovascular Accident, Acute = 0–6 months post
stroke, age >18 years, cardiovascular training, cardiopulmonary training, cardiorespiratory training, aerobic
training, endurance training, exercise, endurance exercise, ergometry, cycling, rowing, treadmill, cardiovascular fitness, aerobic fitness, condition, endurance, physical conditioning, VO2 maximal, VO2 maximum,
VO2 peak, maximal oxygen uptake, heart rate, neural recovery, neural rehabilitation, functional recovery,
function recovery, quality of life. Handsearching was also performed and experts were contacted by email
or telephone for further information about unpublished and unclear data.
Results: Of the 803 total citations initially identified, 11 studies ultimately fulfilled all criteria and were
selected for review. Ten studies were RCTs or randomized controlled pilot studies, and 1 study was a
prospective controlled matched design. The SR identified fair to good evidence indicating that stroke
survivors may benefit from cardiovascular exercise during sub-acute stages to improve peak oxygen
uptake and walking distance. Thus, cardiovascular exercise should be considered in sub-acute stroke
rehabilitation.
Critique/Bottom Line: Despite limitations, this SR provides some promising evidence for post-stroke
rehabilitation. According to this SR, cardiovascular exercise interventions and exercise testing protocols
using leg cycle ergometry have been found to be safe and feasible in the sub-acute stage after stroke. The
authors assert that there is robust evidence that individuals with acute stroke, like Mrs. M, may benefit from
these protocols to improve peak oxygen uptake, walking distance and endurance. Cardiovascular exercise
protocols should be considered and possibly implemented into sub-acute stroke rehabilitation using sound,
patient-centered clinical reasoning. Clinicians and researchers should follow ACSM guidelines for exercise
testing and prescription to ensure medical safety of training protocols and comparability for future analyses.
Further research is needed to develop appropriate methods for cardiovascular rehabilitation early after
stroke and to evaluate long-term effects of cardiovascular exercise on aerobic capacity, physical
functioning, and quality-of-life.
29
Reference #20:
Zijlstra A, Mancini M, Chiari L, Zijlstra W. Biofeedback for training balance and mobility tasks in older
populations: A systematic review. J Neuroeng Rehab. 2010; 7(58). doi:10.1186/1743-0003-7-58.
Level of Evidence: 3a, Pedro N/A
Purpose: The purpose of this systematic review was to evaluate the feasibility and the effectiveness of
biofeedback-based interventions in populations of healthy older persons, mobility-impaired older adults and
frail older adults, i.e. older adults that are characterized by residential care, physical inactivity and/or falls.
Methods: The authors searched electronic databases including PubMed, EMBASE, Web of Science, the
Cochrane Controlled Trials Register, CINAHL and PsycINFO. The search strategy was formulated with the
assistance of an experienced librarian and was modified for various databases that did not have MeSH key
terms registries (EMBASE, Web of Science, CINAHL and PsycINFO). Detailed keyword and MeSH term
lists were provided with thorough tracking of modifications within 3 main categories: 1) biofeedback, 2)
Movement OR Posture OR Musculoskeletal Equilibrium, 3) Middle Aged OR Aged. To identify further
studies, a ‘Related Articles’ search in PubMed and ‘Cited Reference Search’ in Web of Science were
performed and reference lists of primary articles were scanned. Experts were contacted to identify grey
literature, to obtain full-text articles and to provide study details as needed. Two reviewers independently
screened papers and included controlled studies in older adults (>60 years old) if they applied biofeedback
during repeated practice sessions, and if they used at least one objective outcome measure of a balance or
mobility task. Two independent reviewers then rated study quality using the PEDro rating scale.
Results: Twenty-one studies met inclusion criteria for review. Seventeen were RCTs and 4 were controlled
trials. Most available studies did not systematically evaluate feasibility aspects; however the authors
asserted that reports of high participation rates, low drop-out rates, absence of adverse events and positive
training experiences suggest that biofeedback methods can be applied in older adults. The authors found
that there was an indication for effectiveness of visual and auditory feedback-based training of balance in
(frail) older adults identified for postural sway, weight-shifting and reaction time and for the Berg Balance
Scale. There were mild-moderate indications for added effectiveness of applying biofeedback during
training of balance, gait, or sit-to-stand transfers in older patients post-stroke.
Critique/Bottom Line: While these results are clinically relevant and should be considered in post-stroke
rehab and gait training, many of the studies were of lower-moderate level of evidence and the SR results
should thus be interpreted with caution and good clinical judgment. Further appropriate intervention studies
are needed in different populations of older adults to make definitive statements regarding the short- and
long-term added effectiveness of biofeedback on measures of functioning in older adults, and particularly in
post-stroke rehabilitation.
30
Excluded Articles:
Exclusion based on publication age greater than 10 years, low relevance to topic/case study, low level of
evidence, poor design, non-human subjects, languages other than English, and conflicts of interest/funding.
Belda-Lois, et al. 2011. Rehabilitation of gait after stroke: a review towards a top-down approach.
Forrester LW, Roy A, Goodman RN, et al. 2013. Clinical application of a modular ankle robot for stroke
rehabilitation.
Francica JV, Bigongiari A, Mochizuki L, Miranda MLJ, Rodrigues B. 2014. Aerobic program in persons
with stroke: a systematic review.
Kendrick D, et al. 2014. Exercise for reducing fear of falling in older people living in the community.
Mehta S, et al. 2013. Resistance training for gait speed and total distance walked during the chronic
stage of stroke: a meta-analysis.
Mehta S, et al. 2012. Cardiovascular conditioning for comfortable gait speed and total distance walked
during the chronic stage of stroke: a meta-analysis.
Nadeau S, Duclos C, Bouyer L, et al. 2011. Guiding task-oriented gait training after stroke or spinal
cord injury by means of a biomechanical gait analysis.
Pereira S, et al. 2010. Functional electrical stimulation for improving gait in persons with chronic stroke.
Peurala SH, Airaksinen O, Jakala P, Tarkka IM, Sivenius J. 2007. Effects of intensive gait-oriented
physiotherapy during early acute phase of stroke. J Rehab Res Dev. 2007: 44(5): 637-48.
Roche A, Laighin G, Coote S. 2009. Surface-applied function electrical stimulation for orthotic and
therapeutic treatment of drop-foot after stroke – A systematic review.
States RA, Pappas E, Salem Y. 2009. Overground physical therapy gait training for chronic stroke
patients with mobility deficits.
Teasell RW, Bhogal SK, Foley NC, Speechley MR. 2003. Gait training post stroke.
Xiao X, Huang D, O’Young B. 2012. Gait improvement after treadmill training in ischemic stroke
survivors: A critical review of function MRI studies.
31
Discussion
Much of the current literature examining interventions used in acute stroke rehabilitation is of low to
moderate quality, with many studies demonstrating questionable reliability, validity and generalizability.
This analysis focused on higher-quality systematic reviews and meta-analyses of current stroke research in
order to answer the PICO question, "Which intervention or combination of interventions is most effective in
facilitating a more efficient, coordinated gait pattern in patients with acute stroke?" Due to high variability in
study design, outcome measures and results, as well as frequent risk of bias, it is challenging to assimilate
the findings of current stroke studies. The results of many studies contradict each other, and occasionally
even contradict themselves. Using a methodological search of major electronic databases and reference
lists, this literature analysis initially identified 892 articles examining gait training post-stroke. Ultimately, 8
higher level SRs and meta-analyses were selected for inclusion. A general consensus was found
indicating that an individualized treatment plan including a combination of the following interventions is
most effective in post-stroke gait facilitation, and particularly in the acute phase of stroke. These
interventions include: therapeutic and cardiovascular exercise; repetitive, task-oriented training; intensive
overground and/or treadmill training; seated and standing static and dynamic balance training; constraintinduced movement therapy (CIMT); treatment of shoulder subluxation; electrical stimulation;
transcutaneous electrical nerve stimulation (TENS); biofeedback; therapeutic ultrasound; acupuncture. In
the moderate- to higher-quality stroke intervention studies that are currently available, combinations of
some or all of these interventions, skillfully customized to each patient's diagnosis and rehabilitation needs,
have been shown to be effective, safe and affordable in facilitating a more efficient, coordinated gait in
patients with acute stroke. These interventions should be implemented as organized, intense rehab
programs that closely monitor patient response. Future research is needed to determine specific, effective
and safe parameters for the application of these interventions in stroke rehabilitation.
32
Interestingly, many studies report that neurodevelopmental approaches, such as NDT/Bobath,
were equivalent or inferior to other approaches in improving walking ability.4,5,18 This does not discount the
possible benefits of NDT in other areas of stroke rehabilitation; however, in terms of gait improvement, the
interventions stated above have been found to be more effective. Despite evidence indicating the efficacy
of other interventions over NDT in acute stroke gait training, many therapists continue to use NDT for this
purpose. Similar to neurodevelopmental approaches, according to the evidence, graded muscle
strengthening and resistance training improve strength but do not appear to transfer to improved walking
ability in acute stroke patients.1,4,15 However, these interventions have been shown to improve comfortable
gait speed and total distance walked in chronic stroke.10 On the other hand, several studies have found
that inventions such as functional electrical stimulation (FES) and electro-mechanical assisted gait training
appear to benefit people in the acute phase of stroke, but not those in the chronic phase.7,9
Much of the evidence is in agreement that intensive mobility training incorporating functional
strengthening (as opposed to basic resistance training), balance and aerobic exercises and practice on a
variety of walking tasks improves gait ability both in acute and chronic stroke. Interestingly, many studies
have reported that overground and treadmill gait training have equivalent effects in acute
rehabilitation.4,12,16 Several more recent studies, however, have found that treadmill training shows
significant and sometimes lasting effects on gait improvement and overall neuroplasticity in ischemic stroke
survivors.19 Building on this, studies have also shown that FES applied to the anterior tibialis muscle
increases motor evoked potentials and can help with foot drop, particularly when coupled with voluntary
movement and treadmill training. This effect has been shown to last up to 30 minutes after gait training
with FES. Functional MRI studies have demonstrated that voluntary movement together with FES was
associated with increased volitional movement, increased brain activity and changes in the primary motor
cortex, the primary and secondary somatosensory cortices, the sensorimotor cortex, and the cerebellum,
as well as increased coupling between specific brain regions. There is also evidence that treadmill training
33
with and without FES can influence brain plasticity with some lasting effects.7,19 Task-specific practice
during treadmill training, as well as visual and auditory biofeedback and cueing, have also been shown to
improve gait symmetry and coordination.4,5,20
In terms of gait efficiency and endurance, there is still some disagreement within the evidence
regarding the extent of benefits gained with cardiorespiratory training in post-stroke rehabilitation; however,
the general consensus is that it is beneficial in combination with other interventions. Several studies have
shown that cardiorespiratory training involving walking appears to improve maximum walking speed,
preferred gait speed, walking capacity and distance, Berg Balance scores and peak oxygen uptake.8,15,17
Aside from functional electrical stimulation and treadmill training, all of the interventions
recommended above were used with the case study selected for this capstone, Mrs. M, who had suffered a
left CVA in November 2014 and was still in the acute phase of stroke throughout her rehabilitation at a
skilled nursing facility prior to her discharge in February. Mrs. M made good progress in physical therapy
and was able to return to Tucson, AZ, as desired; however, she was discharged to another SNF in Tucson
to continue rehabilitation. Electrical stimulation and treadmill training were never used with Mrs. M and she
would have been a good candidate for both. Despite availability, electrical stimulation may not have been
used due to therapists’ unfamiliarity, skill or confidence using it, or simply because therapists’ preferred
other interventions instead. Treadmill training was never performed because the skilled nursing facility did
not own a treadmill and used two recumbent steppers instead. Perhaps receiving electrical stimulation and
treadmill training, in addition to the other interventions Mrs. M received, would have further improved her
right foot drop and facilitated a more efficient, coordinated gait prior to her discharge.
Conclusion
This evidence-based analysis compiled higher-level research on the topic of effective interventions
for gait training in acute stroke rehabilitation, as well as some supporting evidence for interventions in
chronic stroke rehabilitation. It is challenging to find higher-level evidence on this topic due to high
34
variability and high risk of bias; however, this is an important field of rehabilitation and research that
continues to expand and evolve. One of the most significant limiting factors in post-stroke rehabilitation
research is the wide variability of outcome measures used in studies. The implementation and
development of more consistent outcome measures will help create more consistent, effective protocols
and an overall higher level of knowledge.
The bottom line is that even with the moderate level of evidence available at this time, the
suggested interventions have repeatedly been found by higher-level systematic reviews and meta-analyses
to be the most highly recommended and effective interventions for facilitating a more efficient, coordinated
gait pattern in patients with acute stroke. These interventions include: therapeutic and cardiovascular
exercise; repetitive, task-oriented training; intensive overground and/or treadmill training; seated and
standing static and dynamic balance training; constraint-induced movement therapy (CIMT); treatment of
shoulder subluxation; electrical stimulation; transcutaneous electrical nerve stimulation (TENS);
biofeedback; therapeutic ultrasound and acupuncture. These interventions should be implemented as
organized, intense rehabilitation programs that closely monitor patient response. Therapists should
develop safe, individualized, holistic and patient-centered treatment plans incorporating a combination of
these interventions using skilled clinical judgment and chart review, thorough knowledge of precautions and
contraindications, updated evidence, ACSM guidelines and close monitoring of patients including vitals
signs, the need for appropriate assistance and assistive devices, rate of perceived exertion (RPE) and
signs/symptoms of adverse effects (e.g., facial grimacing, shortness of breath, palor, diaphoresis,
unsteadiness). Before initiating any therapeutic interventions, therapists should have a good understanding
of contraindications to beginning therapy, as well as indications for terminating therapy. More high-quality
research is needed involving consistent stroke patient demographics, research designs and outcome
measures, in order to further investigate intervention efficacies and to develop specific, accepted
35
parameters and protocols that provide optimal post-stroke rehabilitation and the best possible patient
outcomes.
36
REFERENCES
1. Brosseau L, Wells GA, Finestone HM, et al. Ottawa panel evidence-based clinical practice guidelines
for post-stroke rehabilitation. Top Stroke Rehabil. 2006; 13(2): 1-269. (ANALYZED)
2. Best Practice Recommendations for Stroke Care: 2013. Heart and Stroke Foundation.
http://strokebestpractices.ca/wp-content/uploads/2013/07/SBP2013_Stroke-RehabilitationUpdate_July-10_FINAL.pdf. Published July 10, 2013. Accessed February 25, 2015.
3. Effects of Stroke. American Heart Association/American Stroke Association website.
http://www.strokeassociation.org/STROKEORG/AboutStroke/EffectsofStroke/Effects-ofStroke_UCM_308534_SubHomePage.jsp. Published October 23, 2012. Accessed February 25, 2015.
4. Eng JJ, Tang PF. Gait training strategies to optimize walking ability in people with stroke: A synthesis
of the evidence. Expert Rev Neurother. 2007; 7(10): 1417-1436. doi:10.1586/14737175.7.10.1417.
(ANALYZED)
5. Hollands KL, Pelton TA, Tyson SF, Hollands MA, van Vliet PM. Interventions for coordination of
walking following stroke: Systematic review. Cochrane Database of Systematic Reviews. 2012; 35(3):
349-359. (ANALYZED)
6. Hunt SC, Gwinn M, Adams TD. Genomics and Health: Stroke Awareness. Centers for Disease Control
and Prevention. 2013. http://www.cdc.gov/genomics/resources/diseases/stroke.htm. Accessed
February 24, 2015.
7. Kafri M, Laufer Y. Therapeutic effects of functional electrical stimulation on gait in individuals poststroke. Ann of Biomed Engin. 2015; 43(2): 451–466. doi: 10.1007/s10439-014-1148-8. (ANALYZED)
8. MacKay-Lyons M. Aerobic treadmill training effectively enhances cardiovascular fitness and gait
function for older persons with chronic stroke. Journal of Physiotherapy 2012; 58(4):271.
9. Mehrholz J, Elsner B, Werner C, Kugler J, Pohl M. Electromechanical-assisted training for walking after
stroke. Cochrane Database of Systematic Reviews. 2013; 7(Art. No. CD006185): 1-100. doi:
10.1002/14651858.CD006185.pub3. (ANALYZED)
10. Mehta S, et al. 2013. Resistance training for gait speed and total distance walked during the chronic
stage of stroke: a meta-analysis.
11. Mozaffarian D, Benjamin EJ, Go AS, et al. Heart disease and stroke statistics – 2015 update: a report
from the American Heart Association. Circulation. doi: 10.1161/CIR.0000000000000152.
12. Peurala SH, Airaksinen O, Jakala P, Tarkka IM, Sivenius J. 2007. Effects of intensive gait-oriented
physiotherapy during early acute phase of stroke. J Rehab Res Dev. 2007: 44(5): 637-48.
13. Post-Stroke Rehabilitation Fact Sheet. National Institute of Neurological Disorders and Stroke (NINDS)
website. http://www.ninds.nih.gov/disorders/stroke/poststrokerehab.htm. Published April 2011. Updated
February 23, 2015. Accessed February 24, 2015.
37
14. Post-Stroke Rehabilitation Brochure. National Institute of Neurological Disorders and Stroke (NINDS)
website. http://www.ninds.nih.gov/disorders/stroke/post-stroke_rehab_brochure_508comp.pdf.
Published April 2011. Accessed February 24, 2015.
15. Saunders DH, Sanderson M, Brazzelli M, Greig CA, Mead GE. Physical fitness training for stroke
patients. Cochrane Database of Systematic Reviews. 2013; 10(Art. No. CD003316). doi:
10.1002/14651858.CD003316.pub5. (ANALYZED)
16. States RA, Pappas E, Salem Y. Overground physical therapy gait training for chronic stroke patients
with mobility deficits. Cochrane Database of Systematic Reviews. 2009; (3). Art. No.: CD006075. doi:
10.1002/14651858.CD006075.pub2.
17. Stoller O, de Bruin ED, Knols R, Hunt KJ. Effects of cardiovascular exercise early after stroke:
systematic review and meta-analysis. BMC Neurology. 2012; 12(45): 1-16. (ANALYZED)
18. Thaut M, Leins A, Rice R, et al. Rhythmic auditory stimulation improves gait more than NDT/Bobath
training in near-ambulatory patients early poststroke: a single-blind, randomized trial.
Neurorehabilitation and Neural Repair. 2007; 21: 455–9.
19. Xiao X, Huang D, O’Young B. Gait improvement after treadmill training in ischemic stroke survivors: A
critical review of function MRI studies. Neural Regeneration Research. 2012; 7(31): 2457-64.
20. Zijlstra A, Mancini M, Chiari L, Zijlstra W. Biofeedback for training balance and mobility tasks in older
populations: A systematic review. J Neuroeng Rehab. 2010; 7(58). doi:10.1186/1743-0003-7-58.
(ANALYZED)
38
APPENDIX A: ANALYSIS WORKSHEETS
Systematic Review – Evidence Appraisal Worksheet: Article #1 Brosseau
Citation (use AMA or APA format): Brosseau L, Wells GA, Finestone HM, et al. Ottawa panel evidencebased clinical practice guidelines for post-stroke rehabilitation. Top Stroke Rehabil. 2006; 13(2): 1-269.
Level of Evidence (Oxford scale): 2a
Does the design follow the Cochrane method?
Appraisal Criterion
Step 1 – formulating the question
• Do the authors identify the focus of the
review
• A clearly defined question should
specify the types of:
• people (participants),
• interventions or exposures,
• outcomes that are of interest
• studies that are relevant to
answering the question
Step 2 – locating studies
 Should identify ALL relevant literature
 Did they include multiple databases?
 Was the search strategy defined and
include:
o Bibliographic databases used as
well as hand searching
o Terms (key words and index
terms)
o Citation searching: reference
lists
o Contact with ‘experts’ to identify
‘grey’ literature (body of
Reader’s Comments
Yes, the focus was to create guidelines for 13 types
of physical rehabilitation interventions used in the
management of adult patients (>18 years old)
presenting with hemiplegia or hemiparesis following
a single clinically-identifiable ischemic or
hemorrhagic cerebrovascular accident (CVA). The
purpose of developing these guidelines was to
promote the appropriate use of various physical
rehabilitation interventions in the management of
stroke survivors. The guidelines are aimed at
various users, including PTs, OTs, physicians and
patients. This article discusses only post-stroke
physical interventions such as therapeutic
exercises, task-oriented training, biofeedback, gait
training, balance training, sensory interventions,
constraint-induced movement therapy (CIMT),
treatment of shoulder subluxation, electrical
stimulation, transcutaneous electrical nerve
stimulation (TENS), therapeutic ultrasound,
acupuncture, and intensity and organization of
rehabilitation.
Yes, the library scientist developed a structured
literature search based on the sensitive search
strategy recommended by The Cochrane
Collaboration and modifications to that strategy
proposed by Haynes et al. The library scientist
expanded the search strategy to identify case
control, cohort, and non-randomized studies and
conducted the search in the electronic databases of
MEDLINE, EMBASE, Current Contents, the
Cumulative Index to Nursing and Allied Health
(CINAHL) and the Cochrane controlled Trials
Register. She also searched the registries of the
Cochrane Field of Rehabilitation and Related
Therapies, the Cochrane Musculoskeletal Group,
39
materials that cannot be found
easily through conventional
channels such as publishers)
o Sources for ‘grey literature’
the Physiotherapy Evidence Database (PEDro) and
the University of Ottawa EBCPGs website. Finally,
she searched the reference lists of all of the
included trials for relevant studies and contacted
content experts for additional studies or “grey
literature.” Keywords were defined in the article.
Part 3:Critical Appraisal/Criteria for Inclusion
• Were criteria for selection specified?
• Did more than one author assess
the relevance of each report
• Were decisions concerning
relevance described; completed
by non-experts, or both?
• Did the people assessing the
relevance of studies know the
names of the authors,
institutions, journal of
publication and results when
they apply the inclusion criteria?
Or is it blind?
Yes, thorough descriptions of criteria for selection,
inclusion and exclusion were presented for each of
the categories and subcategories of interventions
examined. Study inclusion/exclusion occurred in two
separate rounds. First, two trained independent
reviewers appraised the titles and abstracts of the
literature search, using a checklist with the a priori
defined selection criteria. Each reviewer
independently read the title and abstract of each
article and created a list of all of the articles in the
database along with a reason for
including/excluding each article. Full articles were
ordered in the event of uncertainty. Before deciding
whether to include or exclude the article, a
comparison of their individual lists was performed. A
senior reviewer, a methodologist and a clinical
expert (L.B.), checked the two independent lists of
articles and the reasons for inclusion or exclusion to
determine potential inconsistencies. In the 2nd
round of the inclusion and exclusion process, the
pairs of reviewers independently assessed the full
articles for inclusion or exclusion in the study. Using
predetermined extraction forms, the pairs of
reviewers independently extracted data on the
population characteristics, intervention details, trial
design, allocation concealment, and outcomes. The
pairs of reviewers assessed the methodological
quality of the studies using the Jadad Scale, a 5point scale with reported reliability and validity that
assigns 2 points each for randomization and double
blinding and 1 point for description of withdrawals.
The reviewers resolved differences in data
extraction and quality assessment through
consensus with the senior reviewer. The article did
not report whether the assessors were blinded.
Twenty-two total trials were included for comparison
with a total of 923 patients.
Part 3 – Critically appraise for bias:
• Selection –
Due to the wide variety of studies and interventions
examined and the application of high-quality
40
Were the groups in the study
selected differently?
• Random? Concealed?
Performance• Did the groups in the study
receive different treatment?
• Was there blinding?
Attrition –
• Were the groups similar at the
end of the study?
• Account for drop outs?
Detection –
• Did the study selectively report
the results?
• Is there missing data?
•
•
•
•
Part 4 – Collection of the data
 Was a collection data form used and is it
included?
 Are the studies coded and is the data
coding easy to follow?
 Were studies identified that were
excluded & did they give reasons why
(i.e., which criteria they failed).
Are the results of this SR valid?
Appraisal Criterion
1. Is this a SR of randomized trials? Did
findings into clinical practice guidelines, the Ottawa
Panel did not describe each individual study design.
Because the search strategy to identify articles was
expanded to include not only RCTs, but also
controlled clinical trials (CCTs), cohort studies, and
case-control studies, the groups in these studies
were likely selected differently, potentially received
different treatment, were not always blinded, may
not always have accounted for drop outs, may have
selectively reported some results and may have had
some missing data. However, the Ottawa group did
a good job of identifying and including high-quality
evidence. The authors reported they excluded
eligible studies with greater than a 20% drop-out
rate and studies that had insufficient and/or missing
data.
Yes, a collection data form was used and was
included in the article. The studies are coded and
the data coding is easy to follow. Some excluded
studies were identified. The authors described in
detail the number of excluded studies and reasons
why articles were excluded. In total, 27 studies
were excluded because: there was an inappropriate
or no control group (n = 10), healthy subjects were
used (n = 3), insufficient statistical data was
presented (n = 2), they were not specific to stroke
patients (n = 2), they lacked an intervention (n = 1)
or outcomes of interest, or had an inappropriate
study design. Uncontrolled cohort studies (studies
with no comparison group) and case series were
excluded, as were eligible studies with greater than
a 20% drop-out rate or a sample size of fewer than
5 patients per group. Trials published in languages
other than French and English were not analyzed,
due additional time and resources required for
translation. Abstracts were excluded if they
contained insufficient data for analysis and
additional information could not be obtained from
the authors. Further exclusion criteria presented in
Table 1 in the article.
Reader’s Comments
Yes, most of the studies are RCTs, however, the
41
they limit this to high quality studies at
the top of the hierarchies
a. If not, what types of studies were
included?
b. What are the potential
consequences of including these
studies for this review’s results?
2. Did this study follow the Cochrane
methods selection process and did it
identify all relevant trials?
a. If not, what are the
consequences for this review’s
results?
3. Do the methods describe the processes
and tools used to assess the quality of
individual studies?
a. If not, what are the
consequences for this review’s
results?
4. What was the quality of the individual
studies included? Were the results
consistent from study to study? Did the
investigators provide details about the
research validity or quality of the studies
included in review?
authors expanded their search strategy to include
some controlled clinical trials (CCTs), cohort
studies, and case-control studies. Given the limited
availability of high-quality evidence on this topic, the
authors did a good job of establishing inclusion and
exclusion criteria and identifying articles that were
generally of moderate to high quality. By
incorporating some lower-quality evidence into their
analysis instead of just RCTs, the SR’s overall
Oxford level decreased and potential for bias and
threats to validity increased. However, the authors
were able to include some valuable data into their
guidelines that otherwise would have been
excluded.
Yes, the authors used the Cochrane Collaboration
methods in their selection process and it helped
them identify all relevant trials.
Yes, the authors describe how pairs of reviewers
assessed the methodological quality of the studies
using the Jadad Scale, a 5-point scale with reported
reliability and validity that assigns 2 points each for
randomization and double blinding and 1 point for
description of withdrawals. The reviewers resolved
differences in data extraction and quality
assessment through consensus with the senior
reviewer.
Most of the included studies are RCTs, however,
the authors expanded their search strategy to
include some controlled clinical trials (CCTs), cohort
studies, and case-control studies. As stated above,
given the limited availability of high-quality evidence
on this topic, the authors did a good job of
establishing inclusion and exclusion criteria and
identifying articles that were generally of moderate
to high quality. By incorporating some lower-quality
evidence into their analysis instead of just RCTs,
the levels of evidence of the studies ranged from 1b
to 3b. Given the variety of interventions and
outcomes examined, the findings were not
consistent for all outcome measures. However,
there was more than sufficient evidence for the
authors to provide guidelines for a wide variety of
interventions. The investigators provided details
42
about the research validity and the quality of the
studies included in the review.
5. Did the investigators address
publication bias
Are the valid results of this SR important?
Appraisal Criterion
6. Were the results homogenous from study to
study?
a. If not, what are the
consequences for this review’s
results?
7. If the paper is a meta-analysis did they
report the statistical results? Did they
include a forest plat? What other
statistics do they include? Are there
CIs?
8. From the findings, is it apparent what the
cumulative weight of the evidence is?
No, publication bias was not addressed.
Reader’s Comments
To some extent, however, due to limited high-quality
evidence on this topic and the wide variety of
interventions and outcomes examined, the results
were not as homogenous as they could have been if
more research was available. Heterogeneity (i.e.,
variability or difference in estimated effects between
studies) was tested using the chi-square statistic.
The authors tested data heterogeneity across the
results of different included studies. When
heterogeneity was not significant, fixed-effect
models were used. A fixed-effect model is a
statistical model that stipulates that the units under
analysis are the ones of interest and thus constitute
the entire population of units. Fixed-effect models
were used to generalize data across the included
studies. Random-effects models include both withinstudy sampling error (variance) and between-study
variation in the assessment of the uncertainty
(confidence interval) of meta-analysis results. Such
random-effects models were used when
heterogeneity was significant. All figures were
created using Cochrane Collaboration methodology.
Yes, a meta-analysis was performed and the
authors reported the statistical results. Forest plots
were not included in this review. Chi2, P values, I2, Z
values, SDs, and CIs were included in the report.
Yes, the range of evidence was 1b to 3b with the
vast majority of the 33 studies analyzed being
RCTs. The introduction of some lower level
evidence (CCT’s, cohort and case-control studies)
decreased the overall Oxford score from a possible
1a with only RCTs analyzed to a 2a.
Can you apply this valid, important evidence from this SR in caring for your patient/client? What is
the external validity?
Appraisal Criterion
Reader’s Comments
9. Is your patient different from those in
The patients presented in these studies are similar
43
this SR?
10. Is the treatment feasible in your setting?
Do you have the facilities, skill set, time,
3rd party coverage to provide this
treatment?
11. Does the intervention fit within your
patient/client’s stated values or
expectations?
a. If not, what will you do now?
What is the bottom line?
Appraisal Criterion
Summarize your findings and relate this back to
clinical significance
to the capstone case study as the target population
as they were adult patients (>18 years of age)
presenting with hemiplegia or hemiparesis following
a single clinically identifiable ischemic or
hemorrhagic CVA, like Mrs. M. The patients had to
be medically stable and able to follow simple
instructions and to interpret and respond to
feedback signals, also like Mrs. M. The mean
duration since stroke onset in the studies varied
from hyper-acute (the first 12 hours), acute (first
week following a stroke), subacute (from the first to
6th week), and post-acute (from 6 weeks to 6
months) to chronic (from 6 months) as defined by
the Canadian Stroke Network. According to these
definitions, Mrs. M was in the post-acute phase (1-2
months post-stroke). Patients who had been
identified as having multiple CVAs, other
neurological problems, subarachnoid hemorrhages,
or subdural hematomas were excluded. Overall, the
study participants were similar to Mrs. M.
The Ottawa Panel developed 147 positive
recommendations of clinical benefit concerning the
use of different types of physical rehabilitation
interventions involved in post-stroke rehabilitation.
Many of these interventions are already available
and used in many SNF rehabilitation facilities.
However, some are more easily accessible than
others and some require skill sets, time and 3rd party
coverage that may not always be available.
Yes, Mrs. M wanted to “walk normally again” and,
according to the research and clinical practice
guidelines presented in this review, the
recommended interventions have the potential to
help her do this.
Reader’s Comments
This is a well-done and very thorough SR providing
graded, evidence-based clinical practice guidelines
(CPGs) for therapists treating patients in various
stages of stroke. Ultimately, the Ottawa Panel
graded and recommended the use of many
interventions: therapeutic exercise, task-oriented
training, biofeedback, gait training, balance training,
constraint-induced movement therapy, treatment of
44
shoulder subluxation, electrical stimulation,
transcutaneous electrical nerve stimulation,
therapeutic ultrasound, acupuncture, and intensity
and organization of rehabilitation in the
management of post stroke. The SR and CPGs
were well researched and did a good job of
considering clinical significance, in addition to
statistical significance and grading the evidence and
interventions accordingly. The evidence, grading
and CPGs are easy to follow and provide a nice,
evidence-based foundation for therapists
considering various interventions for the post-stroke
population. The above interventions are
recommended by the Ottawa Panel, a
comprehensive multidisciplinary panel of experts
specializing in post-stroke rehabilitation, and should
be considered in post-stroke physical therapy using
an individualized, patient-centered approach and
good clinical reasoning.
Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett
Publishers, Sudbury, MA 2008
45
Systematic Review – Evidence Appraisal Worksheet: Article #2 Eng
Citation (use AMA or APA format): Eng JJ, Tang P. Gait training strategies to optimize walking ability in
people with stroke: A synthesis of the evidence. Expert Rev Neurother 2007 Oct; 7(10): 1417-1436.
DOI:10.1586/14737175.7.10.1417.
Level of Evidence (Oxford scale): 2a
Does the design follow the Cochrane method?
Appraisal Criterion
Step 1 – formulating the question
• Do the authors identify the focus of the
review
• A clearly defined question should
specify the types of:
• people (participants),
• interventions or exposures,
• outcomes that are of interest
• studies that are relevant to
answering the question
Reader’s Comments
Yes, the author’s clearly state that the focus of this
paper is to systematically review common gait
training strategies (neurodevelopmental techniques,
muscle strengthening, treadmill training, intensive
mobility exercises) to improve walking ability in
people after stroke. The results (descriptive
summaries as well as pooled effect sizes) from
randomized controlled trials are presented and
implications for optimal gait training strategies are
discussed.
Step 2 – locating studies
 Should identify ALL relevant literature
 Did they include multiple databases?
 Was the search strategy defined and
include:
o Bibliographic databases used as
well as hand searching
o Terms (key words and index
terms)
o Citation searching: reference
lists
o Contact with ‘experts’ to identify
‘grey’ literature (body of
materials that cannot be found
easily through conventional
channels such as publishers)
o Sources for ‘grey literature’
Yes, a keyword search using Medline, CINAHL, and
Cochrane Collaboration was performed using the
terms gait, locomotion, walking, ambulation
combined with stroke or cerebrovascular disease
(CVA). In addition, hand searching of references
from these articles was performed. Primary
importance was placed on recent meta-analyses
and systematic reviews if they were available.
Individual randomized controlled trials (RCTs) were
also assessed. For areas with multiple RCTs where
current meta-analyses were not available, a pooled
standardized effect size with confidence intervals
(CI) was constructed across trials. The authors did
not report contacting experts or sources to identify
grey literature.
Part 3:Critical Appraisal/Criteria for Inclusion
• Were criteria for selection specified?
• Did more than one author assess
the relevance of each report
• Were decisions concerning
relevance described; completed
by non-experts, or both?
Yes, the review focused on exercise interventions
and did not evaluate the literature pertaining to
assistive devices or modalities. Following the search
(n=1482), studies were eliminated if they did not
involve a RCT, involved populations other than
adults with stroke, reported no walking outcome
measures, were not journal publications (e.g.,
46
•
Did the people assessing the
relevance of studies know the
names of the authors,
institutions, journal of
publication and results when
they apply the inclusion criteria?
Or is it blind?
abstracts), or were not written in English, There
were 9 systematic reviews or meta-analyses which
included gait outcomes. Common interventions
were collated and the literature was sorted into the
topics of neurodevelopmental techniques (n=7),
strength training (n=5) and task-specific training
(treadmill (n=17) and intensive mobility training
(n=10).
The article does not state whether more than one
author assessed the relevance of each report. They
also do not mention anything about the assessors
knowing the authors, institutions, publication journal
or results when applying inclusion criteria or
whether it was blind.
Part 3 – Critically appraise for bias:
• Selection –
• Were the groups in the study
selected differently?
• Random? Concealed?
• Performance• Did the groups in the study
receive different treatment?
• Was there blinding?
• Attrition –
• Were the groups similar at the
end of the study?
• Account for drop outs?
• Detection –
• Did the study selectively report
the results?
• Is there missing data?
Selection - The article did not provide detailed
description/analysis of each study in terms of
selection, randomization and concealment
procedures.
Performance – The groups in each study received
different interventions and thus received different
treatment. The article provides descriptions and
charts summarizing the author, year, subjects,
program description and results but the reviewers
did not provide information regarding blinding within
the studies or within the review.
Attrition – The reviewers provided limited
information regarding similarities at the end of the
studies but did describe similarities found between
studies. They provided limited information regarding
drop-outs (i.e., one study had 2 dropouts) and did
not state whether the studies accounted for dropouts.
Detection – Since very limited
procedural/methodological information was provided
about the included studies, there appears to be
missing data and it is difficult to know whether
studies selectively reported results. However, the
reviewers state that they only included randomized
controlled trials (RCTs). It does not appear that the
reviewers selectively report the results.
Part 4 – Collection of the data
The reviewers did not state whether a specific
47



Was a collection data form used and is it
included?
Are the studies coded and is the data
coding easy to follow?
Were studies identified that were
excluded & did they give reasons why
(i.e., which criteria they failed).
Are the results of this SR valid?
Appraisal Criterion
12. Is this a SR of randomized trials? Did
they limit this to high quality studies at
the top of the hierarchies
a. If not, what types of studies were
included?
b. What are the potential
consequences of including these
studies for this review’s results?
13. Did this study follow the Cochrane
methods selection process and did it
identify all relevant trials?
a. If not, what are the
consequences for this review’s
results?
collection data form was used and one was not
included. There are tables in the appendix
summarizing each included study and the
International Classification of Functioning (ICF)
Model used. The studies are coded and
summarized in tables. Both the coding and included
tables are easy to follow; however, some of the
studies overlapped which made it difficult to
determine the levels of evidence. Some excluded
studies were identified and briefly discussed.
Specific details regarding the excluded studies’
failed criteria were not provided.
Reader’s Comments
Yes, this is a SR of randomized trials. However, the
reviewers did not limit this to high-quality studies as
several studies are of low-moderate quality (Oxford
1a-4). The potential consequences of including
these studies are a lower overall Oxford ranking,
potential for bias, heterogeneity, as well as
questionable reliability/validity and generalizability.
The authors did not state whether they used the
Cochrane selection process, but they did state their
methods to include all relevant trials. They used
specific electronic databases, including the
Cochrane Collaboration, as well as manually
searching reference lists. The potential
consequences of this are that all relevant studies
may not have been identified and lower-quality
evidence was included.
14. Do the methods describe the processes
and tools used to assess the quality of
individual studies?
a. If not, what are the
consequences for this review’s
results?
No, the processes and tools used to assess quality
of individual studies were not described. The only
assessment tool described was the International
Classification of Functioning (ICF) model, which was
for gait problems, outcome measures and potential
environmental factors affecting walking ability. The
potential consequences are that systematic quality
assessment may not have occurred and lower-level
studies were included.
15. What was the quality of the individual
studies included? Were the results
No. As stated above, the reviewers did not limit the
SR to high-quality studies and several studies of
48
consistent from study to study? Did the
investigators provide details about the
research validity or quality of the studies
included in review?
16. Did the investigators address
publication bias
Are the valid results of this SR important?
Appraisal Criterion
17. Were the results homogenous from study to
study?
a. If not, what are the
consequences for this review’s
results?
18. If the paper is a meta-analysis did they
report the statistical results? Did they
include a forest plat? What other
statistics do they include? Are there
CIs?
19. From the findings, is it apparent what the
cumulative weight of the evidence is?
low-moderate quality (1a-4) were included. Some of
the results were consistent from study to study but
some results varied. The investigators did not
provide many details about the research validity or
quality of the studies included in the review.
No, publication bias was not addressed.
Reader’s Comments
Some of the results were homogenous from study to
study; however, some results were more
heterogeneous. For example, some studies
reported improved gait speed with treadmill training
and bodyweight-supported gait training (BWSTT)
while other studies found no differences in gait
speed between control and experimental groups.
The reviewers stated thorough but general results
for each of the categories they had divided the
articles into and described the most common trends;
however, they did not provide any type of forest plot
or other means of showing homogeneity or
heterogeneity. Heterogeneity makes it difficult or
impossible to draw valid conclusions.
The author’s reported the statistical results of their
meta-analysis. They did not include any forest plots.
They include effect sizes, d and p values, and CIs.
Due to the general low to moderate level of
evidence and diverse outcome measures, it is
difficult to establish a cumulative weight of the
included evidence. Of the 39 articles included,
evidence ranged from Oxford 1b to 4.
Can you apply this valid, important evidence from this SR in caring for your patient/client? What is
the external validity?
Appraisal Criterion
Reader’s Comments
20. Is your patient different from those in
Some of the participants and data were similar to
this SR?
my case study, such as participants with acute
stroke (<3 months) requiring min-mod assistance in
ambulation and having little to no spasticity. My
case study did not receive treadmill training,
BWSTT or EMG; however, she did receive
components of some of the other interventions
49
researched in this SR (e.g., NDT/Bobath, PNF,
conventional PT, motor relearning/neuromuscular
reeducation, resisted
/isokinetic/isometric/strengthening exercises,
resistance band exercises, balance exercises,
functional exercises, overground gait training).
21. Is the treatment feasible in your setting?
Do you have the facilities, skill set, time,
3rd party coverage to provide this
treatment?
To some extent. Many of the interventions are
feasible and already utilized in the SNF rehab
setting. This SR found that treadmill training had
equivalent effects to overground gait training in subacute rehabilitation but indicated that a combination
of treadmill with task-specific practice may be
optimal. Advanced Health Care SNF currently uses
NuStep recumbent steppers and overground gait
training for patients with acute stroke and does not
employ any type of treadmill or bodyweightsupported treadmill training. They currently employ
neurodevelopmental approaches and graded
muscle strengthening which, according to this SR
and others analyzed for this capstone, have little to
no effect on walking ability. This SR found that
neurodevelopmental approaches were equivalent or
inferior to other approaches to improve walking
ability and graded muscle strengthening (not using
functional activities) improved muscle strength but
did not transfer to improved walking ability.
However, the reviewers did find that intensive
mobility training incorporating functional
strengthening, balance and aerobic exercises and
practice on a variety of walking tasks improves gait
ability both in sub-acute and chronic stroke. Many
of these interventions are already incorporated at
the Advanced SNF and the therapists have the
equipment, skill set, time (45-75 min sessions), and
3rd party coverage to provide these treatments.
22. Does the intervention fit within your
patient/client’s stated values or
expectations?
b. If not, what will you do now?
Yes, the patient in the case study presented stated
that she wanted to “walk normally again” and to
return to Arizona. Many of the interventions found
to improve walking ability are already employed at
Advanced Health Care and were utilized with this
patient. Treadmill training with task-specific practice
and BWSTT was not used with this patient due to
limited resources; however, this also would have fit
within her values and expectations.
50
What is the bottom line?
Appraisal Criterion
Summarize your findings and relate this back to
clinical significance
Reader’s Comments
This is a well-done SR and meta-analysis examining
available literature for gait training strategies to
optimize walking ability in people with stroke. Of the
39 articles included, 7 investigated
neurodevelopmental techniques, 5 examined
strength training, 17 examined task-specific training
(i.e., treadmill) and 10 examined intensive mobility
training. Nine articles were systematic reviews or
meta-analyses that included gait outcomes.
Much of the research on this topic tends to be of low
to moderate quality, bias is common and outcome
measures tend to be diverse and difficult to pool;
however, the researchers did a good job of
identifying a good body of evidence to perform a SR
and meta-analysis. The general consensus of this
article was that: 1) neurodevelopmental approaches
were equivalent or inferior to other approaches to
improve walking ability, 2) graded muscle
strengthening (not using functional activities)
improves muscle strength, but does not transfer to
improved walking ability, 3) treadmill training had
equivalent effects to overground gait training in subacute rehabilitation and beneficial effects compared
to low intensity control groups in chronic stroke, 4) a
combination of treadmill with task-specific practice
may be optimal, 5) intensive mobility training which
incorporates functional strengthening, balance and
aerobic exercises and practice on a variety of
walking tasks improves gait ability both in sub-acute
and chronic stroke.
These findings were interesting because many of
the interventions used in the included studies were
used with the case study patient selected for this
capstone. This included neurodevelopmental
techniques and graded muscle strengthening, which
were found to have little to no effect on walking
ability in this article. The case study patient, who
had acute stroke, received overground gait training
which was found to have equivalent effects to
treadmill training in sub-acute stoke patients in this
51
SR. It was interesting that treadmill training was
found to have beneficial effects in chronic stroke
more than acute stroke and that the reviewers
suggest treadmill training with task-specific practice
may be optimal. Intensive mobility training
incorporating functional strengthening (repetitive,
functional tasks), balance training, aerobic exercise
and varied walking tasks was also utilized with the
capstone case study patient and appeared to
improve her gait abilities (i.e., static/dynamic
balance, walking endurance, step length and
symmetry), coinciding with the findings in this
article.
Further research is needed in this area and should
include large RCTs and multi-site collaborations
with larger sample sizes, long-term follow-up of
walking ability, evaluation of important secondary
complications (e.g., falls, fractures, heart disease
and recurrence of stroke) and common outcome
measures (e.g., gait speed, 6-minute walk test) and
potentially new outcome measures relevant to
walking abilities. Future research should also
investigate mechanisms that contribute to
ambulation gains (e.g., brain plasticity, postural
control, aerobic, strengthening), as well as quantify
the dose and intensity of training (e.g., using
accelerometers, step counters and heart rate
monitors).
Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett
Publishers, Sudbury, MA 2008
52
Systematic Review – Evidence Appraisal Worksheet: Article #3 Hollands
Citation (use AMA or APA format): Hollands KL, Pelton TA, Tyson SF, Hollands MA, van Vliet PM.
Interventions for coordination of walking following stroke: Systematic review. Cochrane Database of
Systematic Reviews. 2012; 35(3): 349-359.
Level of Evidence (Oxford scale): 3a
Does the design follow the Cochrane method?
Appraisal Criterion
Step 1 – formulating the question
• Do the authors identify the focus of the
review
• A clearly defined question should
specify the types of:
• people (participants),
• interventions or exposures,
• outcomes that are of interest
• studies that are relevant to
answering the question
Reader’s Comments
Yes, the authors clearly state that they are
examining current non-surgical and nonpharmacological rehabilitation interventions that
treat gait coordination impairments, the effects of
identified interventions on measures of gait
coordination and overall walking ability compared to
no treatment and the theoretical basis on which they
are derived. The authors sought to identify all
interventions which aim to address gait coordination
(as a putative mechanism of gait dysfunction) in
stroke survivors and explore their effects on gait
coordination and overall gait ability. This facilitated
an examination of the hypothesis that restoration of
a coordinated gait pattern is a mechanism to
improve overall walking ability. The authors also
sought to identify gaps in the current knowledge
base, directions for future research and promising
interventions for further study.
The authors clearly defined the people (stroke
survivors), interventions (any PT intervention or
experimental manipulation to effect gait, provided
the design yielded evidence for the potential efficacy
of the intervention), outcomes of interest (effects on
gait coordination), and relevant studies (33 studies
involving examining gait coordination that met
inclusion criteria).
Step 2 – locating studies
 Should identify ALL relevant literature
 Did they include multiple databases?
 Was the search strategy defined and
include:
o Bibliographic databases used as
well as hand searching
o Terms (key words and index
terms)
Yes, the following databases were searched:
Cochrane Stroke Group Trials Register, Cochrane
Central Register of Controlled Trials (CENTRAL)
(The Cochrane Library), MEDLINE, EMBASE,
CINAHL, AMED, National Institutes of Health (NIH)
Clinical Trials Database host: NIH, National
Institute of Clinical Studies. The following
rehabilitation specific databases which include both
peer reviewed and some un-peer reviewed content
53
o Citation searching: reference
lists
o Contact with ‘experts’ to identify
‘grey’ literature (body of
materials that cannot be found
easily through conventional
channels such as publishers)
o Sources for ‘grey literature’
Part 3:Critical Appraisal/Criteria for Inclusion
• Were criteria for selection specified?
• Did more than one author assess
the relevance of each report
• Were decisions concerning
relevance described; completed
by non-experts, or both?
• Did the people assessing the
relevance of studies know the
names of the authors,
institutions, journal of
publication and results when
they apply the inclusion criteria?
Or is it blind?
Part 3 – Critically appraise for bias:
• Selection –
• Were the groups in the study
selected differently?
• Random? Concealed?
• Performance• Did the groups in the study
receive different treatment?
• Was there blinding?
• Attrition –
• Were the groups similar at the
were searched: OTseeker, OT Search,
Physiotherapy Evidence database (PEDro),
Chartered Society of Physiotherapy Research
Database, and REHABDATA. The search strategy
was defined, however, the authors did not mention
hand searching, reference lists, contact with experts
or grey literature.
The authors provided a detailed description of
their search strategy which used a combination of
controlled vocabulary (MeSH) and free text terms,
was limited to English papers with human
participants and was used for MEDLINE and
modified to suit other databases. However, they did
not specify which words were used. At the top of the
SR, the authors listed the keywords “stroke,” “gait,”
“coordination,” and “rehabilitation.” It is likely these
were some of the keywords included in their search
but it is difficult for the reader to know. The authors
provided a nice flow diagram of their search
process, identification and management of studies.
Yes, selection of the studies was performed
according to Cochrane Review guidelines. Two of
the authors (KH, PvV) read each reference and,
based on the inclusion criteria, independently
ranked these as ‘possibly relevant’ or ‘definitely
irrelevant.’ If both identified a trial as ‘definitely
irrelevant,’ it was included in the SR. Consensus
was achieved through discussion, including a third
author if necessary (TP). The article did not report
any blinding of the assessors selecting the studies.
Studies recruited on average 17 participants (range
1–58) with all non-randomized studies employing
convenience samples. Participants were typically
greater than 6 months post-stroke, with only five
studies involving participants in the acute stages (<3
months) of recovery. Most participants were
relatively able, with self-selected walking speeds
between 0.4 m/s and 0.8 m/ s, indicating they were
‘‘limited community walkers.’’
The interventions provided were grouped into
54
•
end of the study?
• Account for drop outs?
Detection –
• Did the study selectively report
the results?
• Is there missing data?
subcategories: task-specific practice of walking (n =
13); ankle-foot orthoses (AFOs) or functional
electrical stimulation (FES) (n = 7); auditory cueing
(n = 6) and exercise (n = 4), imagery and balance
training (n=3). The intensity with which the
interventions were given was broad. Nine studies
only applied the intervention for a few repetitions of
walking in a single session but typically
interventions were delivered over multiple sessions
(e.g. 36 sessions of locomotor training).
Of the 33 trials included, only 9 studies were
randomized controlled trials (RCT). Intention-totreat analysis was not reported in any of the
included studies. However, attrition was an issue for
only two; both with an approximate 30% lost to
follow up. Few studies used blinded outcome
assessors but the SR author’s reported that this
design fault was countered by the use of relatively
unbiased measurement procedures (e.g. three
dimensional motion analysis and gait analysis) and
that, therefore, generally these studies were of
sound methodological design. The SR authors
provided several tables summarizing the studies,
interventions, and duration, intensity, and frequency
used.
All of the remaining studies employed same-subject
designs allowing participants to act as their own
control, hence equality of baseline characteristics
was controlled for. Only four of these studies
included any randomization. While none of these
studies used blinded assessors, all outcome
measurements used standardized protocols and
reportedly unbiased measurement systems (e.g.
three-dimensional motion analysis systems).
Each of the studies utilized different control
conditions (e.g. overground walking (OG), treadmill
training (TT), therapist assisted walking and
different control comparisons such as comparisons
before and after the intervention (pre-, post-test) or
comparing the intervention and control conditions
rather than intervention and control groups. Key
design features and methodological quality of the
selected studies were presented in tables divided
55
into randomized and non-randomized studies.
Part 4 – Collection of the data
 Was a collection data form used and is it
included?
 Are the studies coded and is the data
coding easy to follow?
 Were studies identified that were
excluded & did they give reasons why
(i.e., which criteria they failed).
Are the results of this SR valid?
Appraisal Criterion
23. Is this a SR of randomized trials? Did
they limit this to high quality studies at
the top of the hierarchies
a. If not, what types of studies were
included?
b. What are the potential
consequences of including these
studies for this review’s results?
The search algorithm was included along with
inclusion and exclusion criteria. The studies are
coded and the coding is easy to follow. The authors
did not state which specific articles were excluded,
but they did report how many were excluded and
gave specific reason why studies were excluded.
The included studies were presented in tables by
author name, which were easy to follow and
included relevant details.
Reader’s Comments
Yes and no. The authors reported that few highquality RCTs with a low risk of bias specifically
targeting and measuring restoration of coordinated
gait were found. Consequently, they took a
pragmatic approach to describing and quantifying
the available evidence and included nonrandomized study designs. They also reported that
they limited the influence of heterogeneity in
experimental design and control comparators by
restricting meta-analyses to pre- and post-test
comparisons of experimental interventions only.
Studies that compared measurement of an
intervention with a control were included. This
included randomized and quasi-randomized
controlled trials, case–control studies, cohort
studies, and before–after studies. Studies which
only reported data for comparisons between healthy
control groups and stroke participants or had no
control or baseline comparisons were excluded.
Studies that did not explicitly state the objective was
to determine the effects on gait coordination, but
used a coordination measure as an outcome
measure were included. There were only 9 RCTs
included out of the 33 studies analyzed for this SR.
The quality of studies ranged from 1b to 3b.
Potential consequences of this include a lower level
of evidence analyzed and a potential for bias in
favor of a beneficial effect, potentially biasing the
results of the SR as well. The results of this SR
should thus be treated with caution. The authors
56
assert that their choose of design was reasonable,
given that the aim of this review was to establish the
‘state of the art’ for coordination of walking, to
establish what evidence there was to inform future
research directions, rather than to establish the
effectiveness of interventions.
24. Did this study follow the Cochrane
methods selection process and did it
identify all relevant trials?
a. If not, what are the
consequences for this review’s
results?
25. Do the methods describe the processes
and tools used to assess the quality of
individual studies?
a. If not, what are the
consequences for this review’s
results?
Yes, the authors state that the selection of studies
was performed according to Cochrane Review
Guidelines and provide the Cochrane reference.
They stated their methods in order to include all
relevant trials using specific electronic databases.
26. What was the quality of the individual
studies included? Were the results
consistent from study to study? Did the
investigators provide details about the
research validity or quality of the studies
included in review?
The quality of the individual studies ranged from
Oxford levels 1b to 3b. The studies were presented
in tables outlining methodological quality of
randomized and non-randomized studies, as well as
participant demographics and characteristics of
design and intervention content for studies
examining task specific interventions, ankle-foot
orthotic interventions, auditory cueing interventions,
exercise interventions, and miscellaneous
interventions. The researchers reported that they
included non-randomized study designs and
restricted meta-analyses to pre- and post-test
comparisons of experimental interventions only, in
order to limit the influence of heterogeneity in
experimental design and control comparators. The
results were fairly consistent from study to study.
Yes, the methods described the processes and
tools used to assess the quality of the individual
studies. KH and PvV independently assessed the
methodological quality of selected studies using a
modified version of the Joanna Briggs Institute (JBI)
critical appraisal checklist for cohort/case control.
They reported that, for rigor and detail, additional
questions from Downs and Black’s checklist were
added. The authors then independently extracted
means and standard deviations from each outcome
measure as well as participant demographics and
details of the study design. These details are
presented in easy-to-follow tables throughout the
article.
The investigators provided details about the
research validity/quality of included studies. They
57
reported that the interventions that showed the most
promise (auditory cueing and task-specific practice),
included all the RCTs thereby giving the most
validity to their effect. The author’s reported that
most of these studies reduced risk of bias
introduced from a lack of blinding of outcome
assessor and intention-to-treat analyses, by using
unbiased measurement procedures and limited loss
of data at follow up. The authors also reported that
small convenience samples used in the orthotic and
exercise intervention studies limit their external
validity and translation into recommendations for
clinical practice.
27. Did the investigators address
publication bias
Are the valid results of this SR important?
Appraisal Criterion
28. Were the results homogenous from study to
study?
a. If not, what are the
consequences for this review’s
results?
29. If the paper is a meta-analysis did they
report the statistical results? Did they
include a forest plat? What other
statistics do they include? Are there
CIs?
No, publication bias was not discussed.
Reader’s Comments
Yes, the results were fairly homogenous favoring
treatment; however, the reader must interpret these
results with caution. As stated above, the
researchers reported they included non-randomized
study designs and restricted meta-analyses to preand post-test comparisons of experimental
interventions only, in order to limit the influence of
heterogeneity in experimental design and control
comparators.
Yes, the authors performed a meta-analysis and
reported the statistical results. They included
several forest plots presenting the effect of all
treatment subcategories on self-selected gait
symmetry and on gait speed. Tau2, Chi2, df, P
values, I2, Z values and CIs are included.
30. From the findings, is it apparent what the The range of evidence was Oxford 1b to 3b. Due to
cumulative weight of the evidence is?
the inclusion of non-randomized and quasirandomized controlled trials, as well as case–
control, cohort, and before–after studies, it is difficult
to create a cumulative weight of the evidence
presented. Also, the authors reported they restricted
meta-analyses to pre- and post-test comparisons of
experimental interventions only, in order to limit the
influence of heterogeneity in experimental design
and control comparators. This also makes it difficult
to create a cumulative weight. Because lower level
58
evidence was included and the results are to be
interpreted with caution, the cumulative weight
would be an Oxford 3a.
Can you apply this valid, important evidence from this SR in caring for your patient/client? What is
the external validity?
Appraisal Criterion
Reader’s Comments
31. Is your patient different from those in
Much of the data presented in this SR is relevant to
this SR?
the case study in this capstone, such as the fact that
these patients are stroke survivors, hemiparetic,
mostly female, and relatively able. However,
participants were typically greater than 6 months
post-stroke, with only five studies involving
participants in the acute stages (<3 months) of
recovery.
32. Is the treatment feasible in your setting?
Do you have the facilities, skill set, time,
3rd party coverage to provide this
treatment?
Yes, the interventions provided in the included
studies were grouped into subcategories: taskspecific practice of walking, ankle-foot orthoses
(AFOs) or functional electrical stimulation (FES),
auditory cueing, exercise, imagery and balance
training. These are all interventions that are
generally fairly easy to access, implement and
establish 3rd party coverage for in SNF rehab
facilities. AFOs and FES would likely be the most
difficult of the interventions to obtain if not already
available and would require skill sets that some
therapists might not possess. However, according
to this SR, AFOs and FES produced the least
amount of change.
33. Does the intervention fit within your
patient/client’s stated values or
expectations?
c. If not, what will you do now?
Yes, these interventions would fit with my patient’s
values and expectations because she had an
increased right step length and steppage gait (slap
foot) and wanted to “walk normally again.”
What is the bottom line?
Appraisal Criterion
Summarize your findings and relate this back to
clinical significance
Reader’s Comments
This review aimed to identify interventions used to
treat gait coordination impairments, their theoretical
basis and any evidence for their effects in order to
identify those warranting further investigation.
59
Of the 33 included trials, only 9 were RCTs, which
lowered the quality of evidence. Data from 19
studies were entered in to the meta-analysis to
assess the effects the interventions on gait
coordination and gait speed. A sub-group analysis
was also carried out to assess the effect of each
type of intervention on the outcomes.
When combined, the interventions had a moderate,
positive effect on gait coordination. However, only
auditory cueing showed a significantly positive (in
that the participants’ gait became more symmetrical)
effect when the different types of intervention were
considered individually. Exercise showed a nonsignificant negative effect, in that the patient’s gait
became less symmetrical during or after the
intervention. Overall, the interventions showed
significant improvements on gait speed. Each type
of intervention also showed a positive effect.
Auditory cueing showed the greatest effect, task
specific practice and exercise had small but positive
effects, while orthoses and FES produced the least
change.
Although these results appear to be very positive
and to favor treatment, they must be interpreted with
caution and should not be considered definitive
evidence of effectiveness. The results indicate that
interventions involving auditory cueing and taskspecific practice of walking may positively influence
gait coordination after stroke. They also found that
overall improvements in gait coordination coincided
with increased walking speed, lending support to the
hypothesis that interventions targeting lower limb
coordination may be a mechanism to improve
walking for some people with stroke. These are
relatively affordable and safe interventions that have
some evidence of effectiveness and may be
beneficial to some stroke patients; however, further
research and future high-quality studies are needed.
Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett
Publishers, Sudbury, MA 2008
60
Systematic Review – Evidence Appraisal Worksheet: Article #4 Kafri
Citation (use AMA or APA format): Kafri M, Laufer Y. Therapeutic effects of functional electrical
stimulation on gait in individuals post-stroke. Ann of Biomed Engin. 2015; 43(2): 451–466. doi:
10.1007/s10439-014-1148-8.
Level of Evidence (Oxford scale): 2a
Does the design follow the Cochrane method?
Appraisal Criterion
Step 1 – formulating the question
• Do the authors identify the focus of the
review
• A clearly defined question should
specify the types of:
• people (participants),
• interventions or exposures,
• outcomes that are of interest
• studies that are relevant to
answering the question
Reader’s Comments
Yes, the primary aim of this work was to
systematically present and to critically review
reported therapeutic benefits in regard to body
function (e.g., muscle strength and tone) and
mobility-related activities (e.g., gait speed)
associated with lower extremity (LE) functional
electrical stimulation (FES) in individuals poststroke. Sixteen studies met inclusion criteria for
review.
Step 2 – locating studies
 Should identify ALL relevant literature
 Did they include multiple databases?
 Was the search strategy defined and
include:
o Bibliographic databases used as
well as hand searching
o Terms (key words and index
terms)
o Citation searching: reference
lists
o Contact with ‘experts’ to identify
‘grey’ literature (body of
materials that cannot be found
easily through conventional
channels such as publishers)
o Sources for ‘grey literature’
Electronic databases used were: PubMed, CINAHL,
PEDro, and Scopus with the last full search
conducted in July 2014. The electronic search was
completed by a hand search of bibliographic
references of the included studies.
Part 3:Critical Appraisal/Criteria for Inclusion
• Were criteria for selection specified?
• Did more than one author assess
the relevance of each report
• Were decisions concerning
relevance described; completed
by non-experts, or both?
Yes, inclusion and exclusion criteria were specified.
Both authors assessed the relevance of each report
and no blinding was reported. Decisions concerning
relevance were described; however, there was no
mention of others contributing to decisions of study
relevance.
The search terms used were [functional electrical
stimulation OR neuromuscular electrical stimulation]
AND [stroke OR hemiparesis OR cerebrovascular
accident] AND [gait OR walking OR locomotion].
The search was restricted to clinical trials and the
English language. The titles and abstracts of all
identified articles were reviewed, with the full article
read whenever deemed necessary to finalize a
decision about its inclusion. There was no report of
contact with experts to identify grey literature.
61
•
Did the people assessing the
relevance of studies know the
names of the authors,
institutions, journal of
publication and results when
they apply the inclusion criteria?
Or is it blind?
Inclusion criteria
1. Clinical trials that evaluated the therapeutic
effects of FES to the LE of patients following a
stroke by assessing at least one activity measure
before and after treatment when FES was not
applied.
2. At least one experimental and one control (or
placebo) group were evaluated. Cross over design
studies were included only if subjects were divided
into two groups and crossed over for experimental
and control interventions.
3. If FES was applied with an additional treatment
and the control group received the same treatment.
Exclusion criteria
1. PEDro score of <4.
2. Less than ten participants in each intervention
group. 3. No inferential statistics reported.
4. FES was applied only for one session
5. Studies not reported in peer-reviewed journals,
and only reported as conference proceedings,
posters, theses, or dissertations.
Part 3 – Critically appraise for bias:
• Selection –
• Were the groups in the study
selected differently?
• Random? Concealed?
• Performance• Did the groups in the study
receive different treatment?
• Was there blinding?
• Attrition –
• Were the groups similar at the
end of the study?
• Account for drop outs?
• Detection –
• Did the study selectively report
the results?
• Is there missing data?
The specific selection methods for the individual
studies were not specified. Of the 16 included
studies, eligibility criteria were reported in 14
students. Baselines were reportedly comparable in
13 studies. Fourteen of the 16 studies were RCTs.
Allocation was concealed in 8 of the studies. Due to
the nature of the intervention, subjects were blinded
in only 1 study and therapists were never blinded in
any of the studies. Assessors were blinded in 7
studies. Adequate follow-up occurred in 13 studies.
Attrition was never mentioned in the SR but
intention-to-treat was reported in 5 studies. All of
the studies had between group comparisons, point
estimates and variability. Each study was analyzed
in depth and tables presented the PEDro level of
evidence, study name, study design, number of
groups, time of evaluation, group assignments,
number and age of subjects, time post-stroke,
walking speed at pretest (m/s) or walking ability,
outcome measures and main therapeutic results.
Part 4 – Collection of the data
 Was a collection data form used and is it
The authors did not mention a collection data form
and one was not included. However, the search
62


included?
Are the studies coded and is the data
coding easy to follow?
Were studies identified that were
excluded & did they give reasons why
(i.e., which criteria they failed).
Are the results of this SR valid?
Appraisal Criterion
34. Is this a SR of randomized trials? Did
they limit this to high quality studies at
the top of the hierarchies
a. If not, what types of studies were
included?
b. What are the potential
consequences of including these
studies for this review’s results?
35. Did this study follow the Cochrane
methods selection process and did it
identify all relevant trials?
a. If not, what are the
consequences for this review’s
results?
algorithm was included with inclusion and exclusion
criteria. The studies were coded and the coding
was easy to follow. The studies were also
presented in tables by author name. The authors did
not state which specific articles were excluded, but
they did state how many were excluded and the
failed criteria.
Reader’s Comments
Yes, 14 of the 16 studies analyzed for this SR were
RCTs but the 2 remaining trials were not
randomized. The quality of the studies ranged from
4 to 8 on the PEDro scale. The potential
consequences of this include a lower level of
evidence analyzed, lower overall SR and MA quality
and a potential for bias.
The authors did not report use of the Cochrane
methods selection process, but they did state their
methods to include relevant evidence. They used
specific databases and hand searched bibliographic
references. The potential consequences of not
using the Cochrane methods are that all relevant
trials may not have been identified, validity and
generalizability may be limited and there is a
potential for publication bias.
36. Do the methods describe the processes
and tools used to assess the quality of
individual studies?
a. If not, what are the
consequences for this review’s
results?
Yes, the describe the quality assessment using the
PEDro classification scale. The authors scored
studies for which a PEDro score was not published.
Due to the nature of the studies, blindness of the
therapist providing the treatment was not possible;
hence, the maximum possible score was 9. Studies
were rated between excellent and poor on the basis
of the PEDro score: 8–9, excellent; 6–7, good; 4–5,
fair. Studies with a score <4 were excluded from this
review.
37. What was the quality of the individual
studies included? Were the results
consistent from study to study? Did the
investigators provide details about the
research validity or quality of the studies
included in review?
The methodological quality of the included studies
ranged from 4 to 8 on the PEDro scale. Two
studies scored 4, four studies scored 5; five studies
scored 6; four studies scored 7 and one study
scored 8. The mean PEDro score of studies in
which FES was applied as a rehabilitation tool in the
acute and chronic phase was 6.6 (SD1.1) and 5.6
63
(SD1.3), respectively, and the mean score of
studies in which FES was applied as an alternative
to an orthotic device was 5.5 (SD 0.5). Nine studies
received a PEDro score in the ‘good’ range and six
in the ‘fair’ range, with only the study by Ambrosini
et al. rated as ‘excellent.’ Overall, the studies
appeared to have similar/consistent results.
Therapeutic effects of FES were demonstrated at
the body function and activity levels when used as a
training modality. The authors provided details
about the research validity and quality of the studies
in the review.
38. Did the investigators address
publication bias
Are the valid results of this SR important?
Appraisal Criterion
39. Were the results homogenous from study to
study?
a. If not, what are the
consequences for this review’s
results?
40. If the paper is a meta-analysis did they
report the statistical results? Did they
include a forest plat? What other
statistics do they include? Are there
CIs?
41. From the findings, is it apparent what the
cumulative weight of the evidence is?
Publication bias was not discussed.
Reader’s Comments
The results appeared fairly homogenous from study
to study with an overall trend toward favoring
treatment. However, homogeneity and
heterogeneity were not specifically discussed and
statistical values and forest plots were not included.
The authors stated general results for each of the
studies and the most common trends observed.
A meta-analysis was not performed. No forest plots
or CIs were included. Limited statistics were
provided.
The methodological quality of the included studies
ranged from 4 to 8 on the PEDro scale. Two
studies scored 4, four studies scored 5; five studies
scored 6; four studies scored 7 and one study
scored 8. The mean PEDro score of studies in
which FES was applied as a rehabilitation tool in the
acute and chronic phase was 6.6 (SD1.1) and 5.6
(SD1.3), respectively, and the mean score of
studies in which FES was applied as an alternative
to an orthotic device was 5.5 (SD 0.5). Nine studies
received a PEDro score in the ‘good’ range and six
in the ‘fair’ range, with only the study by Ambrosini
et al. rated as ‘excellent.’ Due to the limitations and
lower level of evidence of some of the studies, the
overall Oxford score for the SR would be 2a.
64
Can you apply this valid, important evidence from this SR in caring for your patient/client? What is
the external validity?
Appraisal Criterion
Reader’s Comments
42. Is your patient different from those in
In the studies, therapeutic effects of FES were
this SR?
mainly measured in individuals in the chronic poststroke phase (>3-6 months). Fewer studies
measured the therapeutic effects in people like Mrs.
M in the acute or subacute post-stroke phases (<3
months). A major methodological difference
between studies conducted at the acute and subacute phases compared with studies conducted
during the chronic phase is related to the level of
independent ambulation and general higher
functional performance expected of the participants.
Some of the participants further out from their stroke
were more independent and higher functioning than
Mrs. M. Participants in the studies ranged in age
from 47-80 years old. Mrs. M was just above this at
85 years old. Like Mrs. M, the participants in these
studies had hemiparesis and foot drop but were
able to ambulate with minimal to moderate
assistance.
43. Is the treatment feasible in your setting?
Do you have the facilities, skill set, time,
3rd party coverage to provide this
treatment?
Yes, FES is currently available at Advanced Health
Care SNF; however, it is rarely employed in the
post-stroke patient population. This may be due to
lack of evidence; however, several therapists seem
intimidated by it and/or lack the appropriate
knowledge or skill set. Within 45-75 minute daily
therapy sessions, there is ample time to utilize FES
and 3rd party payers could potentially cover it.
44. Does the intervention fit within your
patient/client’s stated values or
expectations?
d. If not, what will you do now?
Yes, Mrs. M wanted to “walk normally again” and
FES could potentially reduce her foot drop and help
facilitate a more efficient, coordinated gait.
What is the bottom line?
Appraisal Criterion
Summarize your findings and relate this back to
clinical significance
Reader’s Comments
This SR systematically presented and critically
reviewed reported therapeutic benefits in regard to
body function (e.g., muscle strength and tone) and
mobility-related activities (e.g., gait speed)
associated with lower extremity functional electrical
65
stimulation in individuals post-stroke. Fourteen of
the 16 studies included were RCTs.
This study presented a systematic review of the
carryover effects of lower extremity FES to motor
performance when stimulation is not applied
(therapeutic effects) in subjects post-stroke. A
description of advances in FES technologies, with
an emphasis on systems designed to promote LE
function was included, and mechanisms that may be
associated with the observed therapeutic effects
were discussed.
This SR presents moderate but clinically significant
evidence that FES technology has the potential to
promote gait performance and other aspects of LE
motor recovery after stroke. Although available and
easy accessible, FES was not utilized in the
treatment of Mrs. M, the case study in this capstone,
who had hemiparesis and demonstrated foot drop
like the participants in this SR.
FES is a relatively safe, affordable intervention that,
when applied to tibialis anterior muscles, has been
shown to increase motor evoked potentials,
especially when coupled with voluntary movement.
Interestingly, fMRI studies have demonstrated that
voluntary movement together with electrical
stimulation was associated with increased brain
activity and changes in the primary motor cortex, the
primary and secondary somatosensory cortices, the
sensorimotor cortex, and the cerebellum, as well as
with increased coupling between specific brain
regions. There is also some evidence that treadmill
training with FES can influence brain plasticity with
some lasting effects. Further well-controlled studies
are warranted to substantiate these findings and to
further evaluate the therapeutic effects of FES.
Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett
Publishers, Sudbury, MA 2008
66
Systematic Review – Evidence Appraisal Worksheet: Article #5 Mehrholz
Citation (use AMA or APA format): Mehrholz J, Elsner B, Wener C, Kugler J, Pohl M. Electromechanicalassisted training for walking after stroke. Cochrane Database of Systematic Reviews. 2013;7.
DOI:10.1002/14651858.CD006185.pub3.
Level of Evidence (Oxford scale): 2A (SR of RCTs; some studies not randomized/blinded)
Does the design follow the Cochrane method?
Appraisal Criterion
Step 1 – formulating the question
• Do the authors identify the focus of the
review
• A clearly defined question should
specify the types of:
• people (participants),
• interventions or exposures,
• outcomes that are of interest
• studies that are relevant to
answering the question
Step 2 – locating studies
 Should identify ALL relevant literature
 Did they include multiple databases?
 Was the search strategy defined and
include:
o Bibliographic databases used as
well as hand searching
o Terms (key words and index
terms)
o Citation searching: reference
lists
o Contact with ‘experts’ to identify
‘grey’ literature (body of
materials that cannot be found
easily through conventional
channels such as publishers)
o Sources for ‘grey literature’
Reader’s Comments
Yes, the authors clearly state that they are updating
a systematic review they performed in 2007 and
investigating the effects of automated
electromechanical and robotic-assisted gait training
devices for improving walking after stroke. They
state that their aim is to estimate the likelihood or
chance of becoming independent in walking as the
result of these interventions, which is a main
rehabilitation goal for patients after stroke. The
authors describe the 23 studies used and how they
are relevant to their objective.
The authors clearly state that they included all
randomized and randomized cross-over trials
consisting of people over 18 years old diagnosed
with stroke of any severity, at any stage, or in any
setting, evaluating electromechanical and roboticassisted gait training versus normal care. Two
review authors independently selected trials for
inclusion, assessed methodological quality and
extracted the data. The search strategy was
defined and included in the review. The authors
utilized multiple databases: Cochrane Stroke Group
Trials Register, the Cochrane Central Register of
Controlled Trials (CENTRAL), MEDLINE, EMBASE,
CINAHL, AMED, SPORTDiscus, the Physiotherapy
Evidence Database (PEDro), and the engineering
databases COMPENDEX and INSPEC. They also
hand searched relevant conference proceedings,
searched trials and research registers, checked
reference lists and contacted authors to identify
‘grey’ literature or further published, unpublished
and ongoing trials and provided the sources for
these as well. The authors clearly defined the MeSH
terms used: ∗ Orthotic Devices; ∗ Walking;
Combined Modality Therapy [instrumentation;
67
methods]; Equipment Design; Exercise Therapy
[methods]; Gait; Randomized Controlled Trials as
Topic; Robotics [∗ instrumentation]; Stroke
[∗ rehabilitation]; Humans. Searches of the
electronic databases and of trials registers
generated 4747 unique references for screening.
After excluding non-relevant citations, the authors
obtained the full text of 136 papers, and from these,
identified and included 23 trials in the review.
Part 3:Critical Appraisal/Criteria for Inclusion
• Were criteria for selection specified?
• Did more than one author assess
the relevance of each report
• Were decisions concerning
relevance described; completed
by non-experts, or both?
• Did the people assessing the
relevance of studies know the
names of the authors,
institutions, journal of
publication and results when
they apply the inclusion criteria?
Or is it blind?
Yes, two authors (JM, BE) independently selected
and assessed the relevance of each report for
inclusion. Decisions concerning relevance were
described. If any review author was involved in any
of the selected studies, another member of the
review author group not involved in the study
extracted the study information. In cases of
disagreement between the two review authors, a
third member of the review author group (JK)
reviewed the information to decide on inclusion or
exclusion of a study. The authors utilized checklists
to assess and record details of each study
independently. If necessary, the authors contacted
trialists to request more information, clarification and
missing data. They did not state whether
assessment of articles was blind but it likely was
not.
Part 3 – Critically appraise for bias:
• Selection –
• Were the groups in the study
selected differently?
• Random? Concealed?
• Performance• Did the groups in the study
receive different treatment?
• Was there blinding?
• Attrition –
• Were the groups similar at the
end of the study?
• Account for drop outs?
• Detection –
• Did the study selectively report
the results?
• Is there missing data?
Selection- Several of the included studies reported
appropriate selection, randomization, treatment,
attrition and detection methods; however, these
factors varied between studies and the reviewing
authors reported several study methods and risks
as “unclear.” Many studies utilized randomization
tables; random number generators, block
randomization, computer- or software-generated
lists or concealed envelopes; however, several
studies did not specify their methods in these areas,
which introduced potential bias. Of the 23 included
studies, 13 described adequate random sequence
generations and 13 described adequate allocation
concealment.
Performance – The experimental groups in each
study received electromechanical-assisted gait
training using robotic-assisted treadmill training
68
while the control groups received conventional or
“overground” physical therapy. Groups in “crossover” studies received a duration of both overground
and electromechanical-assisted gait training. Of the
23 included studies, 7 reported blinding of the
primary outcome assessment and 9 reported
incomplete outcome data (attrition bias). The
reviewers reported that blinding methods were
“unclear” in 4 included studies and blinding did not
occur in 12 studies.
Attrition – The groups appeared similar at the end of
the study as all participants had experienced some
type of stroke and received similar treatments. Most
studies reported the mean age of participants as 5070 years old; however, 6 studies did not report
mean age and the mean age of participants in 1
study was “unclear.” All of the studies reported the
number of participant drop-outs with 10 reporting
intention-to-treat, 8 not stated/unclear/unknown, 2
reporting no ITT with analysis per protocol, and 1
that did not provide ITT for all drop-outs.
Detection - Two review authors (JM, MP)
independently evaluated the methodological quality
of the included trials using the Cochrane risk of bias
tool. The authors used checklists to assess details
of each included study (i.e., methods of generating
randomization schedule, method of allocation
concealment, blinding of assessors, use of
intention-to-treat, adverse events and drop-outs for
all reasons, important imbalance in prognostic
factors, and participants demographics including
country, number of participants, age, gender, type of
stroke, time from stroke onset to entry in study,
inclusion/exclusion criteria). The authors checked all
methodological quality assessments for agreement
between review authors and resolved
disagreements by discussion. If one of the review
authors was a co-author of an included trial, another
review author (BE or JK) conducted the
methodological quality assessment for that trial.
The author’s contacted trialists to obtain or clarify
any missing data.
Binary (dichotomous) outcomes were analyzed with
an odds ratio (OR) random effects model with 95%
69
confidence intervals (CIs). Continuous outcomes
with mean differences (MDs) were analyzed using
the same outcome scale. Inconsistencies across
studies were quantified using the I2 statistic. A
random-effects model was used for all analyses.
The most current version of the Cochrane Review
Manager software was used for all statistical
comparisons. A formal subgroup analysis using the
Cochrane Handbook for Systematic Reviews of
Interventions was performed to compare
participants treated in the acute and sub-acute
phases of their stroke (within 3 months) with
participants treated in the chronic phase (longer
than 3 months). A sensitivity analysis of
methodological quality was also performed for each
study and the largest study was removed since
some of the review authors were investigators in
that large trial. Two further (post hoc) sensitivity
analyses were also performed which involved
ambulatory status at start of study and type of
device used in trials.
Part 4 – Collection of the data
 Was a collection data form used and is it
included?
 Are the studies coded and is the data
coding easy to follow?
 Were studies identified that were
excluded & did they give reasons why
(i.e., which criteria they failed).
Are the results of this SR valid?
Appraisal Criterion
45. Is this a SR of randomized trials? Did
they limit this to high quality studies at
the top of the hierarchies
a. If not, what types of studies were
included?
b. What are the potential
consequences of including these
studies for this review’s results?
Yes, a collection data form was used and was
included in the article. The studies are coded and
the data coding is easy to follow. The studies that
were excluded were identified and the reasons for
exclusion and failed criteria were described.
Reader’s Comments
The authors reported that they included all
randomized and randomized cross-over trials
consisting of people over 18 years old diagnosed
with stroke of any severity, at any stage, or in any
setting, evaluating electromechanical and roboticassisted gait training versus conventional physical
therapy. Although several studies specified
adequate randomization, blinding and research
processes, this SR included several studies that did
not specify these processes, are ongoing or
awaiting assessment. The potential consequences
of including these studies includes a lower Oxford
70
ranking, potential for bias,
clinical/methodological/statistical heterogeneity, and
questionable reliability/validity and generalizability.
Because some lower-level and ambiguous evidence
was analyzed, this makes it difficult to rate this
study. The author’s state that they included all
randomized and randomized cross-trials which
could make this a 1a study; however, several
studies were included that have
questionable/unclear methods and do not appear to
be truly “randomized” trials. Overall, the reviewers
chose some of the highest quality studies available;
however, most of the studies were of moderate
quality. This review indicates that further highquality research is needed on this topic.
46. Did this study follow the Cochrane
methods selection process and did it
identify all relevant trials?
a. If not, what are the
consequences for this review’s
results?
Yes, the author’s stated multiple times that they
used the Cochrane methods selection process and
identified all relevant trials. They used specific
electronic databases as well as hand searched
relevant conference proceedings, searched trials
and research registers, checked reference lists and
contacted authors to identify ‘grey’ literature.
47. Do the methods describe the processes
and tools used to assess the quality of
individual studies?
a. If not, what are the
consequences for this review’s
results?
Yes, the authors describe in detail the processes
and tools used to asses the quality of individual
studies including several independent reviewers,
checklists for recording study details independently,
Cochrane risk of bias tool, an odds ratio (OR)
random-effects model with 95% CIs, mean
differences, I2 statistical analysis, Cochrane review
Manager software, a formal subgroup analysis, a
sensitivity analysis of methodological quality for
each included study and removing the largest study
in which some of the review authors were
investigators and two further (post hoc) sensitivity
analyses.
48. What was the quality of the individual
studies included? Were the results
consistent from study to study? Did the
investigators provide details about the
research validity or quality of the studies
included in review?
The quality of the individual studies was generally
moderate. Many of the studies were 1b to 2a;
however, some of the studies did not adequately
report randomization and blinding and would be
considered a 4 on the Oxford scale. Despite this,
the results were fairly consistent from study to study
and tended to favor electromechanical-assisted gait
training.
71
The author’s thoroughly described their search
processes and presented them in flow diagrams. A
“risk of bias” table summarizing all of the studies
was also provided. Characteristics of individual
studies were summarized in tables, along with their
risk of bias, the authors’ judgments and support for
those judgments. The authors stated that trials
investigating electromechanical and robotic-assisted
gait training devices are subject to potential
methodological limitations including: “inability to
blind the therapist and participants, so-called
contamination (provision of the intervention to the
control group) and co-intervention (when the same
therapist unintentionally provides additional care to
either treatment or comparison group).” All these
potential methodological limitations introduce the
possibility of performance bias. However, the
author’s state that this was not supported in
sensitivity analyses by methodological quality.
49. Did the investigators address
publication bias
Are the valid results of this SR important?
Appraisal Criterion
50. Were the results homogenous from study to
study?
a. If not, what are the
consequences for this review’s
results?
51. If the paper is a meta-analysis did they
report the statistical results? Did they
The author’s state that a risk publication bias is
present in all systematic reviews. They assert that
they searched extensively for relevant literature in
electronic databases and hand searched
conference abstracts. Additionally, we contacted
and asked authors, trialists and experts in the field
for other unpublished and ongoing trials.
Reader’s Comments
Yes, to some extent. There is limited research on
this topic and the results were not as homogenous
as they could have been if more research was
available. The authors reported general results for
each of the 5 comparison categories they had
investigated: 1) Independent walking at the end of
intervention phase, all electromechanical devices
used, 2) Regaining independent walking ability, 3)
Subgroup analysis comparing participants in the
acute and chronic phases of stroke, 4) Post hoc
sensitivity analysis by ambulatory status at study
onset, and 5) Post-hoc sensitivity analysis: type of
device. The authors presented forest plots indicating
homogeneity between studies.
A meta-analysis was not performed. Forest plots
were included for the various analyses,
72
include a forest plot? What other
statistics do they include? Are there
CIs?
comparisons and outcomes investigated. P values,
I2 statistics, size effects, Chi2, odds ratios and CIs
are included.
52. From the findings, is it apparent what the Due to the inclusion of some lower-level evidence
cumulative weight of the evidence is?
and the ambiguity of some of the included studies, it
is difficulty to identify the cumulative weight of the
evidence. The range of evidence in this review is 1b
to 4.
Can you apply this valid, important evidence from this SR in caring for your patient/client? What is
the external validity?
Appraisal Criterion
Reader’s Comments
53. Is your patient different from those in
My case study is similar to some of the participants
this SR?
in these studies as she is in the acute phase of
stroke and has received physical therapy. However,
my case study patient is 85 years old while the
mean age of participants in these studies was 5070. She received conventional, “overground”
physical therapy treatment and did not receive
treadmill, electromechanical or robotic-assisted gait
training like many of the participants in these
studies. She may have been a good candidate for
these interventions and may have benefited if these
interventions had been available at the facility.
54. Is the treatment feasible in your setting?
Do you have the facilities, skill set, time,
3rd party coverage to provide this
treatment?
Yes to some extent, however, treadmill,
electromechanical and robotic-assisted gait training
tend to require equipment that is not currently
available at Advanced Health Care and many other
SNFs. Additionally, many of the SNF therapists
currently do not have the skill set, time or 3rd party
coverage to provide this treatment. With stronger
evidence, perhaps this could change.
55. Does the intervention fit within your
patient/client’s stated values or
expectations?
e. If not, what will you do now?
Yes, this intervention would fit within my patient’s
values/expectations one of her primary PT goals
was to walk “normally” again after experiencing a
stroke. This intervention has the potential to help
“normalize” gait and to help patients walk
independently again with a low risk of adverse
events.
What is the bottom line?
Appraisal Criterion
Summarize your findings and relate this back to
Reader’s Comments
This is a well-done SR analyzing available literature
73
clinical significance
for electromechanical-assisted training for walking
after stroke. This SR was performed as an update
to a previous SR by the same authors.
The results of this SR indicated that
electromechanical-assisted gait training in
combination with conventional physical therapy
increases the odds of acute, non-ambulatory stroke
patients becoming independent in walking after
stroke. Specifically, people in the first three months
after stroke and those who are unable to walk at
intervention onset seem to benefit the most from
this type of intervention. Results indicate that
people in the chronic phase of stroke (3 months
post) may not benefit from electromechanicalassisted gait training. Electromechanical gait
training did not significantly increase walking
velocity or walking capacity.
These SR results must be interpreted with caution
because (1) some trials investigated people who
were independent in walking at the start of the
study, (2) variations were found between the trials
with respect to devices used and duration and
frequency of treatment, and (3) some trials included
devices with functional electrical stimulation.
Given that necessary equipment, therapist skill set,
time and third party coverage are available,
evidence suggests that electromechanical-assisted
gait training may be a promising adjunct to
conventional physical therapy and alternative to
overground gait training with a low risk of adverse
events.
Further research is needed and should consist of
large, definitive, pragmatic, phase III trials to
address the frequency and duration of
electromechanical-assisted gait training that might
be most effective and how long the benefit might
last.
Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett
Publishers, Sudbury, MA 2008
74
Systematic Review – Evidence Appraisal Worksheet: Article #6 Saunders
Citation (use AMA or APA format): Saunders DH, Sanderson M, Brazzelli M, Greig CA, Mead GE.
Physical fitness training for stroke patients. Cochrane Database of Systematic Reviews. 2013; 10(Art. No.
CD003316). doi: 10.1002/14651858.CD003316.pub5.
Level of Evidence (Oxford scale): 2a
Does the design follow the Cochrane method?
Appraisal Criterion
Step 1 – formulating the question
• Do the authors identify the focus of the
review
• A clearly defined question should
specify the types of:
• people (participants),
• interventions or exposures,
• outcomes that are of interest
• studies that are relevant to
answering the question
Reader’s Comments
Yes, this is an update to a previous SR by the same
authors. They clearly state the purpose of the
review is to “determine whether fitness training after
stroke reduces death, dependence, and disability.
The secondary aims were to determine the effects
of training on physical fitness, mobility, physical
function, health status and quality of life, mood, and
incidence of adverse events.” According to the
authors, although enough evidence is available to
implement fitness training for stroke, the optimal
exercise prescription has yet to be defined.
People: Stroke patients
Interventions: Cardiorespiratory training, resistance
training and mixed training
Outcomes of interest: Case fatality, death or
dependence, disability, adverse effects, vascular
risk factors, physical fitness, mobility (gait speed
and gait capacity), physical function, health status
and quality of life, and mood.
Relevant studies: 45 studies met inclusion criteria
for the review (13 new studies and 32 previously
included studies).
Step 2 – locating studies
 Should identify ALL relevant literature
 Did they include multiple databases?
 Was the search strategy defined and
include:
o Bibliographic databases used as
well as hand searching
o Terms (key words and index
terms)
Yes, the authors performed an extensive search
and provided a detailed descriptions, lists,
appendices, flow diagrams and tables of their
search and selection processes, as well as the key
words and index terms used.
Electronic databases searched were: Cochrane
Stroke Group Trials Register, Cochrane Central
Register of Controlled Trials (CENTRAL),
MEDLINE, EMBASE, CINAHL, SPORTDiscus,
75
o Citation searching: reference
lists
o Contact with ‘experts’ to identify
‘grey’ literature (body of
materials that cannot be found
easily through conventional
channels such as publishers)
o Sources for ‘grey literature’
Science Citation Index Expanded, Web of Science,
Physiotherapy Evidence Database (PEDro),
REHABDATA, Index to Theses in Great Britain and
Ireland, Internet Stroke Centre’s Stroke Trials
Directory database, metaRegister of Controlled
Trials, Internet Stroke Centre’s website, European
Stroke Conference, International Stroke Conference
and the World Stroke Conference.
The authors handsearched relevant scientific
journals that focused on exercise and physical
fitness and are not currently included in The
Cochrane Collaboration handsearching program:
Adapted Physical Activity Quarterly, British Journal
of Sports Medicine, International Journal of Sports
Medicine, Journal of Science and Medicine in Sport,
Research Quarterly for Exercise and Sport, Sports
Medicine.
They examined the references lists of all relevant
studies identified by the above methods and
examined all relevant systematic reviews identified
during the entire search process for further trials.
They also checked all the references in both the
studies awaiting classification and ongoing studies
sections of the previous version of this review. They
contacted experts in the field and principal
investigators of relevant studies to inquire about
“grey literature,” unpublished and ongoing trials.
Part 3:Critical Appraisal/Criteria for Inclusion
• Were criteria for selection specified?
• Did more than one author assess
the relevance of each report
• Were decisions concerning
relevance described; completed
by non-experts, or both?
• Did the people assessing the
relevance of studies know the
names of the authors,
institutions, journal of
publication and results when
they apply the inclusion criteria?
Or is it blind?
Yes, the authors provided detailed descriptions,
lists, appendices, flow diagrams and charts of their
selection processes and inclusion/exclusion criteria.
One review author (DS) read the titles and abstracts
of all citations identified by the electronic searches
and excluded obviously irrelevant reports. They
retrieved the full text of the remaining papers and
two review authors (DS and MS) independently
assessed these and selected trials which met the
pre-specified inclusion criteria. Any disagreements
were resolved by discussion and if necessary in
consultation with a third review author (GM or CG).
One review author (DS) also screened the
correspondence with experts and trial investigators
for details of any additional published or
unpublished trials. There was report of these
76
assessors being blinded.
Part 3 – Critically appraise for bias:
• Selection –
• Were the groups in the study
selected differently?
• Random? Concealed?
• Performance• Did the groups in the study
receive different treatment?
• Was there blinding?
• Attrition –
• Were the groups similar at the
end of the study?
• Account for drop outs?
• Detection –
• Did the study selectively report
the results?
• Is there missing data?
Two review authors (MS and DS) assessed the risk
of bias for the following items, as described in the
Cochrane Handbook for Systematic Reviews of
Interventions: random sequence generation
,
allocation concealment
, blinding of participants,
blinding of outcome assessment, incomplete
outcome data, selective reporting
, other bias
,
confounded by increased training time. The authors
stated that, For trials of physical interventions like
exercise it is not possible to completely blind
participants or those delivering interventions;
however, some trials may incorporate a degree of
blinding.
The authors assessed less that half (20/45, 44%) of
the included studies as having a low risk of bias. All
studies identified that randomization had occurred;
however, many did not describe the specific
processes. Allocation concealment was poorly
reported in 9 of the included trials (20%)(i.e.,
unclear reporting of the use of ‘sealed envelopes’).
The authors assert that participants cannot be
blinded to physical interventions like fitness training
and in most circumstances (43/45 trials, 96%) the
risk of bias is automatically ‘high,’ though some
trials implemented some degree of participant
blinding. The authors considered the outcome
assessment to be at low risk of detection bias in 19
included trials (42%). Outcome assessment was
not blinded in 6 trials.
Due to the number of included studies and variety of
interventions and outcome measures examined,
several groups were selected and treated
differently. A total of 2188 stroke survivors (range
13 to 250 individuals, mean 44.5, median 42) were
randomized to physical fitness training or control
interventions in the 45 included clinical trials (mean
age = 64 years; mean time since onset of symptoms
= 8.8 days to 7.7 years). Trials varied in the
demographics and ambulation abilities of
participants, the stage at which interventions were
implement, the interventions examined, and the
overall study design (e.g., 3 of the included
cardiorespiratory training trials had more than one
77
intervention group). Most of the included trials
recruited participants during hospital or community
stroke care; however, participants’ recruitment in a
few trials involved media advertisements or
databases of potential volunteers. These methods
of recruitment make these trials more vulnerable to
self-selection bias and hamper the generalizability
of their findings.
Twenty-one trials reported the use of an ITT
approach for their analyses although one of these
trials did not analyze data for the participants who
dropped out. Of the 24 trials that did not mention
ITT, 15 did not have any missing data.
Incomplete outcome data arose from participant
attrition meaning all outcomes were affected. At the
end of intervention, 38 included studies reported an
attrition rate of 10% or less, 5 trials reported an
attrition rate between 10% and 20%, and 2 trials
exceeded an attrition rate of 20%. Overall, the
authors judged 33 trials (73%) as being at low risk
of attrition bias at the end of intervention and 7 of 20
trials at the end of follow-up (35%).
Additionally, trials in which the participants received
an unequal amount of exposure to the interventions
are at high risk of bias. This is a confounding
source. The effects of fitness training could thus be
exaggerated in more than half of the included
studies (23 or 51%) due study designs in which the
training intervention groups received greater time of
exposure than accounted for in the training
program.
Part 4 – Collection of the data
 Was a collection data form used and is it
included?
 Are the studies coded and is the data
coding easy to follow?
 Were studies identified that were
excluded & did they give reasons why
(i.e., which criteria they failed).
The authors did not specify whether a specific
collection data form was used and it was not
included. However, the author’s presented many
detailed descriptions, lists, appendices, flow
diagrams and tables of all data collected and the
inclusion/exclusion criteria used. The studies were
coded and that data coding is easy to follow.
Specific descriptions and references were provided
for each included and excluded study. Specific
criteria and reasons for exclusion were also
provided.
78
Are the results of this SR valid?
Appraisal Criterion
56. Is this a SR of randomized trials? Did
they limit this to high quality studies at
the top of the hierarchies
a. If not, what types of studies were
included?
b. What are the potential
consequences of including these
studies for this review’s results?
Reader’s Comments
All included studies (n = 45) reported that
randomization had occurred; however, many of the
studies did not describe the specific mechanisms of
randomization. Most of the included studies were of
moderate quality. Small sample sizes and the
ambiguous nature of randomization and allocation in
several studies made it difficult to rate the studies
and the overall quality of this SR and meta-analysis.
The quality of some of the studies ranged from
Oxford 1b to 2b; however, some studies may have
been as low as a 4. Potential consequences of this
are bias, confounding sources, questionable validity
and generalizability, a lower level of evidence
analyzed and a lower overall level of evidence for
the SR.
57. Did this study follow the Cochrane
methods selection process and did it
identify all relevant trials?
a. If not, what are the
consequences for this review’s
results?
Yes, the authors report that this SR followed the
Cochrane methods of selection process. They
developed the search strategies for the electronic
databases with the help of the Cochrane Stroke
Group Trials Search Coordinator and searched
multiple Cochrane Databases. Risk of bias was
assessed using the Cochrane Handbook for
Systematic Reviews of Interventions.
58. Do the methods describe the processes
and tools used to assess the quality of
individual studies?
a. If not, what are the
consequences for this review’s
results?
The methods describe the processes and tools used
to assess the quality of some individual studies.
Each individual study is also summarized and risk
for bias is rated in detailed tables in the appendices.
The authors also described how the Cochrane
methods were utilized in the selection process and
the Cochrane “Risk of bias” tool was employed to
help assess individual and overall study quality.
59. What was the quality of the individual
studies included? Were the results
consistent from study to study? Did the
investigators provide details about the
research validity or quality of the studies
included in review?
All of the 45 included studies reported that
randomization had occurred; however, many of the
studies did not describe the specific mechanisms of
randomization. This, in addition to small sample
sizes and the ambiguous nature of randomization
and allocation in several studies, made it difficult to
rate the studies and the overall quality of this SR
and meta-analysis. Most of the included studies
79
were of moderate quality. Many studies ranged
from Oxford 1b to 2b; however, some studies may
have been as low as a 4, depending on
randomization and allocation mechanisms,
objectivity of exposure and outcome measures and
control for confounders. The investigators provided
details about the research validity and quality of the
studies included in the review.
60. Did the investigators address
publication bias
Are the valid results of this SR important?
Appraisal Criterion
61. Were the results homogenous from study to
study?
a. If not, what are the
consequences for this review’s
results?
62. If the paper is a meta-analysis did they
report the statistical results? Did they
include a forest plat? What other
statistics do they include? Are there
CIs?
63. From the findings, is it apparent what the
cumulative weight of the evidence is?
The authors explained that, to quantify
inconsistency across studies, they used the I2
statistic, which is included in the meta-analysis
graphs in Review Manager 5 (‘RevMan,’ used for
statistical analysis). Where possible, they
investigated publication bias by entering data from
studies included in the relevant meta-analyses in
funnel plots (treatment effect versus trial size). A
funnel plot of 13 studies measuring maximum
walking speed showed a tendency toward
asymmetry, suggesting potential publication bias
during but not after patients received usual care.
Another funnel plot of 10 studies measuring 6-MWT
showed no evidence of asymmetry, suggesting no
publication bias.
Reader’s Comments
Many forest plots were included in the review
presenting fairly homogenous results from study to
study and generally favoring treatment. These
results must be interpreted with caution; however,
as the studies tended to be small and of moderate
quality with some ambiguity regarding design and
methods.
The statistical results of the meta-analysis were
reported and a variety of forest plots were included.
Chi2, I2, mean differences, odds ratios, effect sizes,
SDs, ITT and CIs were included.
Due to the generally lower level of evidence and
ambiguity of some studies included in this SR and
MA, it is challenging to determine a cumulative
weight of the evidence presented. Most of the
included studies were of moderate quality and many
had small sample sizes, unclear design and/or
80
methods and potential for bias. The quality of some
of the studies ranged from Oxford 1b to 2b;
however, some studies may have been as low as a
4. Because of this the overall SR Oxford score is a
2a.
Can you apply this valid, important evidence from this SR in caring for your patient/client? What is
the external validity?
Appraisal Criterion
Reader’s Comments
64. Is your patient different from those in
Some of the data presented in these studies is
this SR?
relevant to the case study, Mrs. M. Participants
were stroke patients with a mean age of 65 and
Mrs. M was 85. The patients in these studies
ranged from ambulatory with minimal assistance to
non-ambulatory. The participants’ stage of stroke
also varied from acute to chronic. Mrs. M was 2-3
months post-stroke and thus still in the more acute
stage of stroke.
65. Is the treatment feasible in your setting?
Do you have the facilities, skill set, time,
3rd party coverage to provide this
treatment?
Yes, many of the cardiorespiratory and mixed
training interventions presented in this SR are
available at SNFs like Advanced Health Care (circuit
training, ergometers, overground gait training,
resistance training). However, some are not (e.g.,
aquatic training, treadmill training).
66. Does the intervention fit within your
patient/client’s stated values or
expectations?
f. If not, what will you do now?
Yes, Mrs. M wanted to “walk normally again” and, if
these interventions could potentially help her
accomplish that affordably and safely, they would fit
within her values and expectations.
What is the bottom line?
Appraisal Criterion
Summarize your findings and relate this back to
clinical significance
Reader’s Comments
This was a moderate quality SR and MA examining
whether fitness training after stroke reduces death,
dependence and disability. The researchers also
aimed to determine the effects of training on
physical fitness, mobility (gait speed and capacity,
of particular interest to this capstone), physical
function, health status and quality of life, mood, and
incidence of adverse events. Three categories of
interventions were examined: cardiorespiratory
training, mixed training and resistance training.
There is fairly low-moderate evidence in general
81
and the evidence presented in this SR and MA was
generally of moderate quality. Diversity and
ambiguity in some study designs and methods,
diverse intentions, and diverse outcome measures
made data pooling difficult. Global indices of
disability show a trend of improvement after
cardiorespiratory training; however, benefits at
follow-up and after mixed training were unclear.
There was insufficient evidence to support the use
of resistance training.
Cardiorespiratory training involving walking
appeared to improve maximum walking speed,
preferred gait speed, walking capacity, and Berg
Balance scores after intervention. Mixed training
involving walking and resistance training appeared
to increase preferred walking speed, walking
capacity and pooled balance scores but the
evidence was weaker. Some mobility benefits
persisted after follow-up.
Although there appears to be a trend toward
improvement with the interventions of
cardiorespiratory training and mixed training, these
results must be interpreted with caution.
Assessment suggested some potential for bias as
the variability and quality of trials indicated limited
reliability and generalizability of the observed
results. Future well-designed trials are needed to
determine the optimal content of the exercise
prescription and identify long-term benefits.
Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett
Publishers, Sudbury, MA 2008
82
Systematic Review – Evidence Appraisal Worksheet: Article #7 Stoller
Citation (use AMA or APA format): Stoller O, de Bruin ED, Knols R, Hunt KJ. Effects of cardiovascular
exercise early after stroke: systematic review and meta-analysis. BMC Neurology. 2012; 12(45): 1-16.
Level of Evidence (Oxford scale): 2a
Does the design follow the Cochrane method?
Appraisal Criterion
Step 1 – formulating the question
• Do the authors identify the focus of the
review
• A clearly defined question should
specify the types of:
• people (participants),
• interventions or exposures,
• outcomes that are of interest
• studies that are relevant to
answering the question
Step 2 – locating studies
 Should identify ALL relevant literature
 Did they include multiple databases?
 Was the search strategy defined and
include:
o Bibliographic databases used as
well as hand searching
o Terms (key words and index
terms)
o Citation searching: reference
lists
o Contact with ‘experts’ to identify
‘grey’ literature (body of
materials that cannot be found
easily through conventional
channels such as publishers)
o Sources for ‘grey literature’
Reader’s Comments
Yes, the authors clearly state that the purpose of
this SR was to evaluate the effectiveness of
cardiovascular exercise (CV) early after stroke and
to provide an overview of the currently available
evidence for the use of CV training in the early
stages after stroke. The aim is to identify strategies
that have the potential to affect physical functioning
and that might be used in future early intervention
type studies for individuals with stroke. The
following specific questions were evaluated: (1)
What is the level of evidence for cardiovascular
exercise interventions to influence aerobic capacity
and physical functioning implemented within six
months after the initial stroke event?; (2) How soon
after the initial stroke event is cardiovascular
exercise introduced?; (3) What is the common
practice for measurement of aerobic capacity early
after stroke?
Yes, the authors searched the databases
MEDLINE/Premedline (OvidSP), EMBASE,
Cochrane Library, CINAHL, and ISI Web of Science
(WOS), and performed an additional focused search
where “stroke” had to be in the title or in the subject
headings. The authors used a combination of
medical subject headings (MeSH) and keywords as
search terms, including the following main terms for
the population: Stroke, Cerebral Stroke, Vascular
Accident, Brain Vascular Accident, Apoplexy,
Cerebrovascular Apoplexy, Cerebrovascular Stroke,
CVA (Cerebrovascular Accident), Cerebrovascular
Accident, Acute Stroke, Acute Cerebrovascular
Accident, Acute = 0–6 months post stroke, age >18
years. For the intervention of interest:
cardiovascular training, cardiopulmonary training,
cardiorespiratory training, aerobic training,
endurance training, exercise, endurance exercise,
ergometry, cycling, rowing, treadmill. For the
83
outcomes of interest: cardio- vascular fitness,
aerobic fitness, condition, endurance, physical
conditioning, VO2 maximal, VO2 maximum, VO2
peak, maximal oxygen uptake, heart rate, neural
recovery, neural rehabilitation, functional recovery,
function recovery, quality of life. The search strategy
was well defined and supplemented by a detailed
flow chart. Articles found through hand search by
scanning reference lists of identified studies
supplemented the search results. The authors
contacted experts by email or telephone for further
information about unpublished and unclear data. Of
the 803 total citations initially found, 11 studies
ultimately fulfilled all criteria and were selected for
review. Ten studies were randomized controlled
trials or randomized controlled pilot studies, and 1
study was a prospective controlled matched design.
Part 3:Critical Appraisal/Criteria for Inclusion
• Were criteria for selection specified?
• Did more than one author assess
the relevance of each report
• Were decisions concerning
relevance described; completed
by non-experts, or both?
• Did the people assessing the
relevance of studies know the
names of the authors,
institutions, journal of
publication and results when
they apply the inclusion criteria?
Or is it blind?
Yes, the authors stated that Analysis methods and
inclusion criteria were specified in advance and
documented in the review protocol, which can be
found in Additional file 1. The authors included
randomized and non-randomized prospective
controlled cohort studies considering cardiovascular
training in the sub-acute stages after stroke. No
language or publication date restrictions were
imposed and only peer-reviewed journal articles
were included. Participants (age >18 years) with
initial stroke in the acute phase deemed medically
stable enough to participate in an aerobic exercise
intervention were considered. All types of stroke
and all severity levels were included. Furthermore,
we considered only studies using cardiovascular,
cardiopulmonary or aerobic training interventions.
Any outcome representing an objective and/or
subjective measure in the field of cardiovascular
fitness, physical condition, endurance, oxygen
uptake, heart rate, neural recovery, functional
recovery, quality-of-life, etc. was included in this
review.
Two reviewers (OS, EDB) performed the
identification and the eligibility assessment
independently in a blinded standardized manner by
scanning the titles, abstracts and keywords.
Disagreements between reviewers were resolved by
84
consensus. If no consensus was found, a third
reviewer (KH) made the final decision.
Part 3 – Critically appraise for bias:
• Selection –
• Were the groups in the study
selected differently?
• Random? Concealed?
• Performance• Did the groups in the study
receive different treatment?
• Was there blinding?
• Attrition –
• Were the groups similar at the
end of the study?
• Account for drop outs?
• Detection –
• Did the study selectively report
the results?
• Is there missing data?
The 11 included studies involved 423 participants
with mild to moderate deficits in motor function and
functional abilities. The main inclusion criteria for the
participants in the studies were: stroke in the acute
and sub-acute phase (0–6 months), ability to
ambulate minimally (measured using Functional
Ambulatory Classification (FAC), Orpington
Prognostic Scale, Fugl-Meyer Score, Barthel Index,
10-Meter Walk Test, Chedoke-McMaster Stroke
Assessment), and appropriate cognitive function
(measured using Mini Mental State Examination).
The main exclusion criterion was serious cardiac
contraindications for exercise testing according to
the American College of Sports Medicine (ACSM).
The specific mechanisms for participant selection
were not described. All of the 11 studies analyzed
employed random allocation of participants to
groups. Four studies used concealed allocation, 10
reported groups that were similar at baseline. Due
to difficulty concealing these types of interventions,
none of the included studies blinded either subjects
or therapists. However, assessors were blinded in 3
studies.
Leg cycle ergometry (5 studies) and treadmill
training (4 studies) were the most common methods
for aerobic exercise in the sub-acute phase
following stroke. One study used task-orientated
circuit class training. Two studies mixed the
interventions using leg cycle ergometry or treadmill
training or aerobic exercise with a stepper or hand
bike. Training duration ranged from 3 to 13 weeks
(mean 6.56 ± 3.7 weeks), whereas training intensity
ranged from 40–80% of heart rate reserve. All
reviewed studies used an intervention protocol
consisting of continuous exercise of 20–90 min
(mean 47.78 ± 25.8 min) for 2–5 sessions per week
(mean 3.44 ± 1.0 sessions/week). The intervention
started 34.28 ± 25.1 days after the initial stroke
event. The earliest time was 6 days post stroke.
Of the 11 total studies, 9 had less than a 15%
dropout rate. Seven studies included an intention85
to-treat analysis. Between group statistics, point
estimates and variability data were reported in all 11
studies. Each study was analyzed in depth and
tables were provided presenting the PEDro score,
study name, participant demographics,
inclusion/exclusion criteria, intervention/exercise
protocol, additional intervention/control group, and
outcomes measures.
Part 4 – Collection of the data
 Was a collection data form used and is it
included?
 Are the studies coded and is the data
coding easy to follow?
 Were studies identified that were
excluded & did they give reasons why
(i.e., which criteria they failed).
Are the results of this SR valid?
Appraisal Criterion
67. Is this a SR of randomized trials? Did
they limit this to high quality studies at
the top of the hierarchies
a. If not, what types of studies were
included?
b. What are the potential
consequences of including these
studies for this review’s results?
The authors developed a data extraction sheet
based on the Cochrane Handbook for Systematic
Reviews of Interventions data extraction template
(The Cochrane Collaboration, Oxford, England),
which was included. The studies are coded and the
data coding is easy to follow. The studies that were
excluded were not identified; however, the authors
gave specific reasons for their exclusion and failed
criteria.
Reader’s Comments
All of the studies included in this SR are RCTs
except one, a controlled cohort study that
randomized allocation of participants into groups but
did not report a randomized selection process. The
SR’s authors limited the number of articles to
moderate- to higher-quality studies, ranging from 4
to 8 on the PEDro scale. The lowest PEDro score
of a 4 was given to one study, while three studies
scored a 5, four studies scored a 6, one study
scored a 7, and two studies scored an 8.
68. Did this study follow the Cochrane
methods selection process and did it
identify all relevant trials?
a. If not, what are the
consequences for this review’s
results?
Yes, the authors stated that they searched the
Cochrane library database, based their data
extraction sheet on the Cochrane Handbook for
Systematic Reviews for Intervention data extraction
template and used the Cochrane Review Manager
(RevMan).
69. Do the methods describe the processes
and tools used to assess the quality of
individual studies?
a. If not, what are the
consequences for this review’s
results?
Yes, two independent reviewers (OS & EDB)
assessed all studies for risk of bias. The PEDro
scale was used for this assessment. Consistent
with PEDro, they only considered the internal
validity (10 items) to assess risk of bias, and used
the cut-points: 9–10 (excellent); 6–8 (good); 4–5
86
(fair); <4 (poor). Disagreements during the quality
assessments were resolved by discussion between
two review authors (OS & EDB); if no agreement
could be reached, a third author (KH) verified the
data and made the final decision. They assessed
the possibility of publication bias by evaluating
funnel plots of the trials’ mean differences for
asymmetry. Heterogeneity of effect sizes was
evaluated by I2 statistics, where at least 50% was
taken as an indicator of substantial heterogeneity.
Inter-rater agreement was considered to be “very
good” (Kappa: 0.81, Standard Error: 0.06, CI95%:
0.70–0.92).
70. What was the quality of the individual
studies included? Were the results
consistent from study to study? Did the
investigators provide details about the
research validity or quality of the studies
included in review?
The quality of the individual studies was “good” (7
studies) to “fair” (4 studies) based on the PEDro
scale. The articles ranged from a 4 to 8 on the
PEDro scale. One study received a 4, three studies
scored a 5, four studies scored a 6, one study
scored a 7, and two studies scored an 8. The
results were fairly consistent overall from study to
study yielding generally homogenous effects
favoring the cardiovascular training intervention
groups, except in interventions addressing gait
speed, which did not show significant results. The
investigators provided details about the research
validity and quality of studies included in the review.
71. Did the investigators address
publication bias
Yes, they assessed the possibility of publication
bias by evaluating funnel plots of the trials’ mean
differences for asymmetry. They also stated that a
publication bias may have been present, as well as
a language bias, given that they considered only
interventions described in published studies and
restricted the search to English, French, and
German language publications.
Are the valid results of this SR important?
Appraisal Criterion
72. Were the results homogenous from study to
study?
a. If not, what are the
consequences for this review’s
results?
Reader’s Comments
Yes to some extent. Peak oxygen uptake data were
available for 155 participants. Pooled analysis
yielded homogenous effects favoring the
intervention group (standardized mean difference
(SMD) = 0.83, CI95% = 0.50–1.16, Z = 4.93, P <
0.01).
Walking endurance assessed with the 6-Minute
87
Walk Test comprised 278 participants. Pooled
analysis revealed homogenous effects favoring the
cardiovascular training intervention group (SMD =
0.69, CI95% = 0.45–0.94, Z = 5.58, P < 0.01).
Gait speed, measured in 243 participants, did not
show significant results (SMD = 0.51, CI95% =
−0.25–1.26, Z = 1.31, P = 0.19) in favor of early
cardiovascular exercise.
73. If the paper is a meta-analysis did they
report the statistical results? Did they
include a forest plat? What other
statistics do they include? Are there
CIs?
Yes, a meta-analysis was performed using a
random-effects model and statistical results were
reported. Three forest plots were included. Other
statistics included were I2, MD, SMD, SD, effect
sizes, p-values, standard errors, Tau2, chi2, df, and
CIs.
74. From the findings, is it apparent what the The quality of the individual studies was “good” (7
cumulative weight of the evidence is?
studies) to “fair” (4 studies) on the PEDro scale.
The articles ranged from a 4 to 8. One study
received a 4, three studies scored a 5, four studies
scored a 6, one study scored a 7, and two studies
scored an 8. On the Oxford scale, the cumulative
weight would be a 2a.
Can you apply this valid, important evidence from this SR in caring for your patient/client? What is
the external validity?
Appraisal Criterion
Reader’s Comments
75. Is your patient different from those in
Mrs. M is very similar to the participants in these
this SR?
studies. This SR defined the “acute” stage as the
first week after stroke onset and the “sub-acute”
stage as 7 days to 6 months after stroke onset.
According to this, Mrs. M is in the sub-acute phase,
like many of the participants. Mrs. M was 85 years
old and the participants were generally between 5070 years old. The participants were deemed
medically stable enough to participate in an aerobic
exercise intervention, much like Mrs. M.
Interestingly, the participants were mildly to
moderately affected, which limits the generalizability
of the SR’s findings for the stroke population at
large but is clinically significant for Mrs. M.
76. Is the treatment feasible in your setting?
Do you have the facilities, skill set, time,
3rd party coverage to provide this
treatment?
Yes, to some extent. Some of the cardiovascular
interventions provided in the studies are available in
some skilled nursing facilities (SNFs); however,
some are not. Advanced Healthcare had a NuStep
88
recumbent stepper, stationary bicycles, and arm
ergometers but does not currently have treadmills.
There are many forms of cardiovascular training and
many physical therapists possess appropriate skill
sets, time and 3rd party coverage to implement this
treatment.
77. Does the intervention fit within your
patient/client’s stated values or
expectations?
g. If not, what will you do now?
What is the bottom line?
Appraisal Criterion
Summarize your findings and relate this back to
clinical significance
Yes, Mrs. M wanted to “walk normally again” and
this included walking faster, safer and longer
distances.
Reader’s Comments
This is a relatively well-done SR and MA providing
an overview of the currently available evidence for
the use of cardiovascular training in the early stages
after stroke. The SR identified fair to good evidence
indicating that stroke survivors may benefit from
cardiovascular exercise during sub-acute stages to
improve peak oxygen uptake and walking distance.
Thus, cardiovascular exercise should be considered
in sub-acute stroke rehabilitation.
However, the study has several limitations that
should be considered: possible publication and
language bias; potentially confounding bias in one
non-randomized study; participants who were
moderately to mildly affected, therefore limiting the
generalizability to the stroke population at large;
lack of data for patients in the very early period after
stroke (<7 days post event); no reports of possible
medication effects on cardiovascular endurance
(e.g., beta-blockers); short intervention durations
without follow-up for the course of outcomes; varied
study quality; limited concealed allocation and
blinding of assessors; analyses of aerobic capacity
strongly varied between studies or were not
described sufficiently to ensure valid comparison;
low publication bias that might account for some
effects in the quantitative analysis.
Clinical relevance: Despite limitations, this SR
provides some promising evidence for post-stroke
rehabilitation. According to this SR, cardiovascular
exercise interventions and exercise testing protocols
89
using leg cycle ergometry have been found to be
safe and feasible in the sub-acute stage after
stroke. The authors assert that there is robust
evidence that individuals with acute stroke, like Mrs.
M, may benefit from these protocols to improve
peak oxygen uptake, walking distance and
endurance. Cardiovascular exercise protocols
should be considered and possibly implemented
into sub-acute stroke rehabilitation using sound,
patient-centered clinical reasoning. Clinicians and
researchers should follow ACSM guidelines for
exercise testing and prescription to ensure medical
safety of training protocols and comparability for
future analyses. Further research is needed to
develop appropriate methods for cardiovascular
rehabilitation early after stroke and to evaluate longterm effects of cardiovascular exercise on aerobic
capacity, physical functioning, and quality-of-life.
Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett
Publishers, Sudbury, MA 2008
90
Systematic Review – Evidence Appraisal Worksheet: Article #8 Zijlstra
Citation (use AMA or APA format): Zijlstra A, Mancini M, Chiari L, Zijlstra W. Biofeedback for training
balance and mobility tasks in older populations: A systematic review. J Neuroeng Rehab. 2010; 7(58).
doi:10.1186/1743-0003-7-58.
Level of Evidence (Oxford scale): 3a
Does the design follow the Cochrane method?
Appraisal Criterion
Step 1 – formulating the question
• Do the authors identify the focus of the
review
• A clearly defined question should
specify the types of:
• people (participants),
• interventions or exposures,
• outcomes that are of interest
• studies that are relevant to
answering the question
Reader’s Comments
Yes, the authors state that the focus of this SR is to
“evaluate the feasibility and the effectiveness of
biofeedback-based interventions in populations of
healthy older persons, mobility-impaired older adults
and frail older adults, i.e. older adults that are
characterized by residential care, physical inactivity
and/or falls.” Twenty-one studies met inclusion
criteria for review.
Step 2 – locating studies
 Should identify ALL relevant literature
 Did they include multiple databases?
 Was the search strategy defined and
include:
o Bibliographic databases used as
well as hand searching
o Terms (key words and index
terms)
o Citation searching: reference
lists
o Contact with ‘experts’ to identify
‘grey’ literature (body of
materials that cannot be found
easily through conventional
channels such as publishers)
o Sources for ‘grey literature’
Electronic databases used were: PubMed,
EMBASE, Web of Science, the Cochrane Controlled
Trials Register, CINAHL and PsycINFO. The
search strategy was formulated with the assistance
of an experienced librarian and was modified for
various databases that did not have MeSH key
terms registries (EMBASE, Web of Science,
CINAHL and PsycINFO). Detailed key word and
MeSH term lists were provided with thorough
tracking of modifications within 3 main categories: 1)
biofeedback, 2) Movement OR Posture OR
Musculoskeletal Equilibrium, 3) Middle Aged OR
Aged.
Part 3:Critical Appraisal/Criteria for Inclusion
• Were criteria for selection specified?
• Did more than one author assess
the relevance of each report
• Were decisions concerning
Yes. Different criteria were applied in selecting
studies for evaluating (1) the feasibility, and (2) the
effectiveness of biofeedback-based training
programs for balance and/or mobility in older adults.
To identify further studies, a ‘Related Articles’
search in PubMed and ‘Cited Reference Search’ in
Web of Science were performed and reference lists
of primary articles were scanned. Experts were
contacted to identify grey literature, to obtain full-text
articles and to provide study details as needed.
91
•
relevance described; completed
by non-experts, or both?
Did the people assessing the
relevance of studies know the
names of the authors,
institutions, journal of
publication and results when
they apply the inclusion criteria?
Or is it blind?
Study selection criteria for feasibility included:
consideration of all available intervention studies
published between 1990-2010, applied biofeedback
for repeated sessions of training balance and/or
mobility tasks in older adults, control-group design,
mean age of 60+, and exclusion of specific medical
conditions.
Study selection criteria for effectiveness included:
studies published up to 2010, the same criteria as
stated for feasibility plus control-group designs
specifically examining biofeedback effectiveness,
and at least one objective measure of performing a
balance or mobility task.
The titles and abstracts of the results obtained by
the database search were screened by 2
independent reviewers (AZ & MM). The full-text
articles of references that were potentially relevant
were independently retrieved and examined. A third
reviewer (WZ) resolved any discrepancies. Only fulltext articles that were in English, Italian or Dutch
were retrieved. In case a full- text article did not
exist, the author was contacted to provide study
details. No method of blinding was reported in the
selection of studies.
Part 3 – Critically appraise for bias:
• Selection –
• Were the groups in the study
selected differently?
• Random? Concealed?
• Performance• Did the groups in the study
receive different treatment?
• Was there blinding?
• Attrition –
• Were the groups similar at the
end of the study?
• Account for drop outs?
• Detection –
• Did the study selectively report
the results?
• Is there missing data?
2 reviewers independently screened papers and
included controlled studies in older adults (i.e. mean
age equal to or greater than 60 years) if they
applied biofeedback during repeated practice
sessions, and if they used at least one objective
outcome measure of a balance or mobility task.
Since no selection criteria were applied regarding
type of participants, besides the criteria of a mean
age of 60 years or higher, the studies included
different populations of mobility-impaired older
adults as well as (frail) older adults without a
specific medical condition.
Studies that complied with the selection criteria for
evaluating the feasibility of biofeedback-based
interventions in older adults or for the effect
evaluation were categorized into groups. A group
consisted of at least 2 studies that evaluated similar
type of interventions, or that had similar training
92
goals, and that were in similar types of older
participants. The author’s reported that there was
some disagreement regarding whether the groups
were similar at baseline and at the end of the
studies.
The authors reported that blinding of subjects and
therapists was not possible in any of the controlled
trials due to the type of study. They also stated that
only 3 articles reported blinding of assessors to
treatment allocation. The authors report that there
was some missing data in some of the studies that
they were not able to obtain, which caused some
disagreement between the authors.
Part 4 – Collection of the data
 Was a collection data form used and is it
included?
 Are the studies coded and is the data
coding easy to follow?
 Were studies identified that were
excluded & did they give reasons why
(i.e., which criteria they failed).
Are the results of this SR valid?
Appraisal Criterion
78. Is this a SR of randomized trials? Did
they limit this to high quality studies at
the top of the hierarchies
a. If not, what types of studies were
included?
b. What are the potential
consequences of including these
studies for this review’s results?
79. Did this study follow the Cochrane
methods selection process and did it
identify all relevant trials?
a. If not, what are the
consequences for this review’s
results?
80. Do the methods describe the processes
and tools used to assess the quality of
individual studies?
Yes, a standardized form was developed to extract
relevant information from the included articles. A
first version was piloted on a subset of studies and
modified accordingly. The form was included in the
article. The studies were coded and easy to follow.
The authors provided a list of excluded studies and
clear reasons and failed criteria for exclusion.
Reader’s Comments
Seventeen of the 21 included studies were RCTs.
The authors included some higher quality studies;
however, several were low-moderate quality
controlled trials. The potential consequences of this
include a lower level of evidence analyzed and thus
a lower Oxford score for the SR itself. There is thus
a potential of bias and questionable reliability,
validity and generalizability. The results of this SR
should thus be interpreted with caution.
No, the authors utilized the Cochrane database but
did not report using the Cochrane methods selection
process. The consequences are that the authors
may not have identified all relevant trials.
Yes, the authors described the processes and tools
used to assess the quality of individual studies.
They reported that 2 reviewers independently
93
a. If not, what are the
consequences for this review’s
results?
81. What was the quality of the individual
studies included? Were the results
consistent from study to study? Did the
investigators provide details about the
research validity or quality of the studies
included in review?
82. Did the investigators address
publication bias
Are the valid results of this SR important?
Appraisal Criterion
83. Were the results homogenous from study to
study?
a. If not, what are the
consequences for this review’s
results?
84. If the paper is a meta-analysis did they
report the statistical results? Did they
include a forest plat? What other
statistics do they include? Are there
CIs?
85. From the findings, is it apparent what the
cumulative weight of the evidence is?
screened papers and independently rated each
study using the PEDro scale.
The overall quality of the individual studies was
Oxford 2b-4. The results varied from study to study.
The authors provided detailed descriptions and
tables summarizing the research validity and quality
of studies.
Yes, the authors reported that, despite the
systematic approach, some potential sources of
bias, such as language and publication bias, may
have influenced the results of the review. In
addition, some relevant studies may have been
overlooked since literature was searched for in
common databases.
Reader’s Comments
No, there was large heterogeneity in study
characteristics and in study results. Some studies
found strong indications for treatment while others
did not. Heterogeneity makes it difficult or
impossible to draw valid conclusions.
This paper was not a meta-analysis and did not
include any forest plots.
Yes, the level of evidence ranged from a 2b to a 4.
Seventeen of the 21 studies analyzed were RCTs
and the remaining 4 were controlled trials. The
cumulative weight of the evidence was on Oxford
3a.
Can you apply this valid, important evidence from this SR in caring for your patient/client? What is
the external validity?
Appraisal Criterion
Reader’s Comments
86. Is your patient different from those in
The demographics of the subjects in the studies
this SR?
included in this SR varied; however, all were males
and females 60 years old or greater. Mrs. M was
85-years-old. Some participants were healthy,
some were mobility-impaired and others were frail
older adults. Some participants had experienced a
stroke, like Mrs. M, and others had not.
94
87. Is the treatment feasible in your setting?
Do you have the facilities, skill set, time,
3rd party coverage to provide this
treatment?
88. Does the intervention fit within your
patient/client’s stated values or
expectations?
h. If not, what will you do now?
What is the bottom line?
Appraisal Criterion
Summarize your findings and relate this back to
clinical significance
Yes, biofeedback is relatively inexpensive and
feasible in the SNF setting. Some therapists may
not have the knowledge or skill set; but the facility
and 3rd party coverage would likely be feasible.
Yes, Mrs. M and her family stated that walking
“normally” again was important to them and
biofeedback could potentially help her attain this.
Reader’s Comments
This article is a SR analyzing 21 articles to evaluate
the feasibility and the effectiveness of biofeedbackbased interventions in populations of healthy older
persons, mobility-impaired older adults and frail
older adults, i.e. older adults that are characterized
by residential care, physical inactivity and/or falls.”
Twenty-one studies met inclusion criteria for review.
Seventeen were RCTs and 4 were controlled trials.
The authors found that there was an indication for
effectiveness of visual and auditory feedback-based
training of balance in (frail) older adults identified for
postural sway, weight-shifting and reaction time and
for the Berg Balance Scale. There were mildmoderate indications for added effectiveness of
applying biofeedback during training of balance,
gait, or sit-to-stand transfers in older patients poststroke.
While these results are clinically relevant and should
be considered in post-stroke rehab and gait training,
many of the studies were of lower-moderate level of
evidence and the SR results should thus be
interpreted with caution and good clinical judgment.
Further appropriate intervention studies are needed
to make definitive statements regarding the shortand long-term added effectiveness of biofeedback
on measures of functioning in post-stroke
rehabilitation.
Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett
Publishers, Sudbury, MA 2008
95
APPENDIX B: DIAGRAM OF SEARCH PROCESS
PubMed
CINAHL
Cochrane
 


362
157
68
“Stroke & physical
therapy & gait
training” with 7
limits



30
15
 

combinations & 6
limits
Web of
Science
PEDro

Keyword Search
“Gait training
post stroke” with
1 limit
Keyword Search
MeSH Database
Keyword


76
Topic Search
“Gait training post
stroke” with 5
limits





806 Excluded:


86

Gait Training Strategies
for Stroke
5

6
Gait Efficiency, Energy
Conservation, CV Fit
Efficacy of Post-Stroke
Walking Aides

18
Interventions for Gait
Coordination, Balance
3
CV Endurance, Gait
Efficiency,

Gait Strategies
3
Gait Efficacy
2
Walking Aides
Gait
Coordination
1
Topic not closely
related, Non-similar
population, low
level of evidence,
>10 years old
35 Excluded:

2
Selected based on
appropriateness/
relevance of title in
relation to PICO
question
43 Excluded:
Total Articles (Relevant to Topic)
11
Gait training acute
stroke; Stroke and
Ambulation, Stroke
and physical
therapy and gait
training
Irrelevant/duplicates,
Low level of evidence
16
19


229
Keyword
Search
“Gait training
post stroke”
6
Keywords used:
Underpowered, bias,
poor study design,
study’s purpose not
closely related to P.I.C.O.
8 Total Studies
-Reviewed
-Analyzed
-Compared to PICO
APPENDIX C: STUDY SUMMARIES TABLE
Oxford
Level of
Evidence
Purpose
Outcome
Measures
Results
Answer
to
Clinical
Question
#
Author
1
Brosseau L, et
al. (2006)
2a
To create guidelines for 13
physical therapy interventions
used in the management of adult
patients (>18 years old) presenting
with hemiplegia or hemiparesis
following a single clinicallyidentifiable ischemic or
hemorrhagic CVA, in order to
promote the appropriate use of
these interventions in stroke
survivors.
- Fugl-Meyer Scale
- Barthel Index
- Berg Balance Scale
(BBS)
- Functional
Independence Measure
(FIM) Scale
- Rivermead Motor
Assessment (RMI)
- EADL
- Gait speed (m/s)
- 2-, 6-, and 10MWT
- Timed Up and Go
(TUG)
The Ottawa Panel graded and
recommended the use of several
interventions to be considered in poststroke rehabilitation: therapeutic exercise,
task-oriented training, biofeedback, gait
training, balance training, constraintinduced movement therapy, treatment of
shoulder subluxation, electrical
stimulation, transcutaneous electrical
nerve stimulation, therapeutic ultrasound,
acupuncture, and intensity and
organization of rehabilitation. They
developed 147 guidelines concerning the
use of these interventions.
Yes
2
Eng JJ, et al.
(2007)
2a
To systematically review common
gait training strategies
(neurodevelopmental techniques,
muscle strengthening, treadmill
training, intensive mobility
exercises), presenting RCT results
and implications for optimal gait
training strategies.
- Sodring Motor
Evaluation Scale
- Motor Assessment
Scale
- RMI Assessment
- Gait speed (m/s)
- 5- and 6MWT
- TUG
- FIM scale
- Functional Ambulatory
Category (FAC)
1) Neurodevelopmental approaches were
equivalent or inferior to other approaches
to improve walking ability. 2) Graded
muscle strengthening (not using functional
activities) improves muscle strength, but
not transfer to improved walking ability.
3) Treadmill training had equivalent
effects to overground gait training in subacute rehabilitation and beneficial effects
compared to low intensity control groups
in chronic stroke. 4) A combination of
treadmill with task-specific practice may
be optimal. 5) Intensive mobility training,
which incorporates functional
strengthening, balance and aerobic
exercises and practice on a variety of
walking tasks, improves gait ability both
in sub-acute and chronic stroke.
Yes
3
Hollands KL,
et al. (2012)
3a
To examine current non-surgical
and non-pharmacological
rehabilitation interventions in the
treatment of gait coordination
impairments, their effects on
measures of gait coordination and
walking ability and their
theoretical basis. To examine the
hypothesis that restoration of a
coordinated gait pattern is a
mechanism to improve overall
walking ability. To identify gaps
in the current knowledge base,
directions for future research and
promising interventions.
4
Kafri M, et al.
(2015)
2a
To systematically present and to
critically review reported
therapeutic benefits in regard to
body function (e.g., muscle
strength and tone) and mobilityrelated activities (e.g., gait speed)
associated with lower extremity
(LE) functional electrical
stimulation (FES) in individuals
post-stroke.
- Gait speed (m/s)
- Gait symmetry
- Due to wide range of
study methodologies
included, outcome
measures were
combined and analyzed
using a random-effects
model. No other
specific outcome
measures were
presented.
- Interventions
included: Task specific
locomotor practice,
AFOs and functional estim, auditory cueing
and exercise were all
assessed.
- FIM Scale
- RMI Assessment
- Functional Reach Test
- LE muscle work/work
ratio
- MVC, TCT, MI, UMC,
EMG, PROM/AROM
- Walking speed
- Number of steps
- Cadence/step length
- TUG
- Tinetti Gait and
Balance
- 6MWT
When combined, the interventions had a
moderate, positive effect on gait
coordination. However, only auditory
cueing showed a significantly positive (in
that the participants’ gait became more
symmetrical) effect when the different
types of intervention were considered
individually. Exercise showed a nonsignificant negative effect, in that the
patient’s gait became less symmetrical
during or after the intervention. Overall,
the interventions showed significant
improvements on gait speed. Each type of
intervention also showed a positive effect.
Auditory cueing showed the greatest
effect, task specific practice and exercise
had small but positive effects, while
orthoses and FES produced the least
change.
This SR provided moderate but clinically
significant evidence that functional
electrical stimulation (FES) technology
has the potential to promote gait
performance and other aspects of LE
motor recovery after stroke. When
applied to tibialis anterior muscles, FES
was shown to increase motor evoked
potentials, especially when coupled with
voluntary movement. FMRI studies have
demonstrated that voluntary movement
together with electrical stimulation was
associated with increased brain activity
and changes in the primary motor cortex,
the primary and secondary somatosensory
cortices, the sensorimotor cortex, the
cerebellum, as well as with increased
coupling between specific brain regions.
There is also some evidence that treadmill
training with FES can influence brain
plasticity with some lasting effects.
Yes
Yes
98
5
Mehrholz J, et
al. (2013)
2a
To update a previous systematic
review performed by the same
authors in 2007. To investigate
the effects of automated
electromechanical and roboticassisted gait training devices for
improving walking after stroke.
To estimate the likelihood or
chance of becoming independent
in walking as the result of these
interventions.
- FAC Assessment
- Barthel Index
- FIM Scale
- RMI Assessment
- Walking speed (m/s)
- 6MWT
- Number of adverse
reactions
6
Saunders DH,
et al. (2013)
2a
To update a previous SR by the
same authors. To determine
whether fitness training after
stroke reduces death, dependence,
and disability. To determine the
effects of training on physical
fitness, mobility (gait speed and
gait capacity), physical function,
health status and quality of life,
mood, and incidence of adverse
events.”
- SF – 36
- State-Trait Anxiety
Inventory
- Muscle strength
- FAC Assessment
- Preferred/Maximal
walking speed
- Paretic knee torque
force analysis
- Biomechanical gait
parameters, stance
symmetry, contact time,
stride cadence
steps/minute, gait
endurance, gait
economy, walking
quality
- 6MWT, TUG, 10Meter Timed Walks
- FIM
- Barthel Index
- Fugl-Meyer Scale
- Health-related QOL
questionnaires
- NEADL, RMI, HADS,
MAS, BBS, BMI,
fatigue questionnaires
- Additional measures
Electromechanical-assisted gait training in
combination with conventional physical
therapy increases the odds of acute, nonambulatory stroke patients becoming
independent in walking after stroke.
Specifically, people in the first three
months after stroke and those who are
unable to walk at intervention onset seem
to benefit the most from this type of
intervention. Results indicate that people
in the chronic phase of stroke (3 months
post) may not benefit from
electromechanical-assisted gait training.
Electromechanical gait training did not
significantly increase walking velocity or
walking capacity.
Cardiorespiratory training involving
walking appeared to improve maximum
walking speed, preferred gait speed,
walking capacity, and Berg Balance scores
after intervention. Mixed training
involving walking and resistance training
appeared to increase preferred walking
speed, walking capacity and pooled
balance scores but the evidence was
weaker. Some mobility benefits persisted
after follow-up.
Global indices of disability show a trend
of improvement after cardiorespiratory
training; however, benefits at follow-up
and after mixed training were unclear.
There was insufficient evidence to support
the use of resistance training.
Yes
Yes
99
7
Stoller O, et
al. (2012)
2a
To evaluate the effectiveness of
cardiovascular exercise (CV) early
after stroke and to provide an
overview of the currently available
evidence for the use of CV
training in the early stages after
stroke. To identify strategies that
have the potential to affect
physical functioning and might be
used in future early intervention
studies for individuals with stroke.
- 5-, 6-, and 10MWT
- FAC Scale
- Functional Mobility
LE
- FMMS UE and LE
- Barthel Index
- Lawton ADL
- Berg Balance Scale
- 4 Square Step Test
- Functional Reach Test
- Leg cycle ergometry
- RMI Score
- Katz-ADL Scale
- Number of stairs
- Stroke Impact Scale
- VO2 consumption,
cost, and peak
- Heart rate rest, work,
and peak
- Blood pressure rest,
work
Fair to good evidence indicating that
stroke survivors may benefit from
cardiovascular exercise during acute
stroke to improve peak oxygen uptake,
walking distance and endurance. The
researchers found that cardiovascular
exercise should be considered and
possibly implemented in acute stroke
rehabilitation using sound, patientcentered clinical reasoning and following
ACSM guidelines for exercise testing and
prescription.
Yes
8
Zijlstra A, et
al. (2010)
3a
To evaluate the feasibility and the
effectiveness of biofeedback-based
interventions in populations of
healthy older persons, mobilityimpaired older adults and frail
older adults, i.e. older adults that
are characterized by residential
care, physical inactivity and/or
falls.
- COP asymmetry
during standing
- Sway during
normal/tandem standing
- CB&M Scale
- 6MWT, BBS, TUG
- Sway (SOT), weightshifting (100%LOS),
and weight distribution
- Base of support
- RMI, EADL, MAS
- Max gait velocity
- Gait: Time-distance,
kinematic/kinetic
parameters
- Stride width, step
length, foot angle
- Velocity, asymmetry
and peak knee extension
during walking and
MAS
There was an indication for effectiveness
of visual and auditory feedback-based
training of balance in (frail) older adults
identified for postural sway, weightshifting and reaction time and for the Berg
Balance Scale. There were mild-moderate
indications for added effectiveness of
applying biofeedback during training of
balance, gait, or sit-to-stand transfers in
older patients post-stroke.
Yes
100
101