Subsymptom Threshold Exercise Training
for Recovery from Postconcussion
Syndrome
By:
David Edward Scussel
Doctoral Candidate
University of New Mexico School of Medicine
Division of Physical Therapy
Class of 2015
Advisor:
Tiffany Pelletier, PT, DCE
Printed Name of Advisor:______________________
Signature:_____________________ Date:_____________
Approved by the Division of Physical Therapy, School of
Medicine, University of New Mexico in partial fulfillment of the
requirements for the degree of Doctor of Physical Therapy.
TABLE OF CONTENTS
Abstract ................................................................................................................ 3
Background and Purpose .................................................................................. 4-7
Case Description ............................................................................................... 7-8
Examination .................................................................................................... 8-11
Evaluation ..................................................................................................... 11-13
Intervention ................................................................................................... 13-14
Outcomes ...................................................................................................... 14-15
Intervention Summary Table ......................................................................... 16-17
Evidence Based Analysis .............................................................................. 18-20
Article Summaries ......................................................................................... 21-29
Discussion ..................................................................................................... 30-32
Conclusion ......................................................................................................... 32
Bottom Line ........................................................................................................ 32
Appendix ....................................................................................................... 33-82
Analysis of Articles ................................................................................. 33-79
Article Summaries Chart ......................................................................... 80-81
Literature Search Strategy ........................................................................... 82
References .................................................................................................... 83-84
2
Abstract
Background
Every year in the United States, athletes experience approximately 1.6 to 3.8 million
sports-related concussions (Darling et al., 2014; Leddy et al., 2012). Estimates as high
as 33% of these individuals may experience prolonged symptoms leading to a diagnosis
of postconcussion syndrome (PCS) (Kozlowski et al., 2013; Leddy et al., 2012).
Subsymptom threshold treadmill testing and exercise training has proven to be safe,
effective, and reliable in treating individuals with PCS (Baker et al., 2012; Darling et al.,
2014; Kozlowski et al., 2013; Leddy et al., 2012; Leddy & Willer, 2013; Leddy et al.,
2013).
Purpose
The purpose of this literature review was to systematically review current literature on
subsymptom threshold treadmill testing and exercise training for treating concussions
and PCS.
Case Description
The patient was a 17 year old male high school junior diagnosed with PCS, presenting
to physical therapy with multiple PCS symptoms including headaches, neck pain,
reduced cervical ROM, and fatigue.
Outcomes
During physical therapy the patient participated in a subsymptom threshold treadmill
test and exercise training protocol, manual therapy, and exercises for the cervical spine
and surrounding musculature. Upon discharge the patient displayed full cervical AROM,
reported no headaches, no neck pain, and was able to exercise without increase in
concussion symptoms. The patient met all physical therapy goals.
Discussion
The majority of concussed individuals who have participated in subsymptom threshold
treadmill testing and exercise training protocols returned to their prior level of
functioning, work and sport (Baker et al., 2012; Darling et al., 2014; Leddy et al., 2010),
and show recovery of brain activity (Leddy et al., 2013).
3
Background and Purpose
After sustaining a concussion during a football drill, a 17 year old male high
school junior was referred to a concussion clinic at a large hospital in Idaho, and
subsequently to the outpatient orthopedic physical therapist on the concussion clinic
team. The patient was diagnosed with postconcussion syndrome, acute post-traumatic
headaches, and cervicalgia. The patient’s symptoms included traumatic and
cervicogenic headaches, cervicalgia, blurry vision, tinnitus, dizziness, depression,
disrupted sleep pattern, and difficulty with memory, concentration, and processing. The
patient played varsity football and basketball. The patient’s goal was to return to sport
as soon as possible, as football season was ending and basketball season was
beginning soon. In order to be able to return to sport after sustaining a concussion,
patients must be free of all concussion symptoms while practicing at game level
intensity, according the Zurich Consensus Conference Concussion Guidelines (McCrory
et al., 2013).
Every year in the United States athletes experience approximately 1.6 to 3.8
million sports-related concussions (Darling et al., 2014; Leddy, Sandhu, Sodhi, Baker, &
Willer, 2012). A concussion is defined by McCrory et al. (2013) as “a brain injury and is
a complex pathophysiological process affecting the brain, induced by biomechanical
forces” (p. 555). Concussion symptoms can include loss of consciousness, amnesia,
headaches, cervicalgia, increased resting heart rate, exaggerated sympathetic nervous
activity, decreased cerebral autoregulation affecting cerebral blood flow, behavioral
changes such as irritability, slowed processing, difficulties with memory, diminished
concentration ability, fatigue, dizziness, tinnitus, visual focusing difficulties, disrupted
4
sleep pattern, depression, and anxiety (Leddy et al., 2010; Leddy et al., 2012; McCrory
et al., 2013).
The majority of individuals who experience a concussion have full recovery within
7-10 days (Leddy et al., 2010). Estimates as high as 33% of these individuals may
experience prolonged symptoms, leading to a diagnosis of postconcussion syndrome
(PCS) (Kozlowski, Graham, Leddy, Devinney-Boymel, & Willer, 2013; Leddy et al.,
2012). Postconcussion syndrome is defined by the World Health Organization as the
“persistence of 3 or more of the following after head injury: HA, dizziness, fatigue,
irritability, insomnia, concentration difficulty, or memory difficulty” (Boake et al., 2005 as
cited by Leddy et al., 2010, p. 21).
The Zurich guidelines, composed by McCrory et al. (2013), use a stepwise
progression of advancing a concussed individual to return to play/work (RTP). The
stepwise progression has 6 stages: Stage 1 - no activity (physical and cognitive rest),
Stage 2 - light aerobic exercise (intensity <70% of maximum heart rate), Stage 3 - sport
specific exercise (aerobic drills, running), Stage 4 - noncontact training drills (a
progression to more complex training drills), Stage 5 - may start progressive resistance
training and full contact practice, and Stage 6 - RTP. An individual must be
asymptomatic for a 24-hour period while within any of the stages to be able to advance
to the next stage. If any symptoms arise during a stage, the patient should drop back to
the previous asymptomatic stage for an additional 24 hours before being advanced
again. Potentially, a person could fully recover from a concussion within a week if they
were able to advance through the stages without reoccurrence of symptoms. The Zurich
guidelines are widely used in the medical community to determine when a concussed
5
individual can RTP. However, the authors of the Zurich guidelines admit the guidelines
are not a proven, reliable outcome based method for returning individuals to work or
sport.
Although concussions are very prevalent in both athletes and non-athletes, until
recently a safe, effective and reliable method for exercise testing and training affected
individuals was not available. Through a series of studies Dr. John J. Leddy, MD and his
cohorts have devised a safe, effective and reliable method to test for concussion
symptoms, and to begin training individuals with PCS in order to resolve their symptoms
efficiently (Baker, Freitas, Leddy, Kozlowski, & Willer, 2012; Darling et al., 2014;
Kozlowski et al., 2013; Leddy et al., 2010; Leddy, Baker, Kozlowski, Bisson, & Willer,
2011; Leddy et al., 2012; Leddy & Willer, 2013; Leddy et al., 2013).
The method devised by Dr. Leddy’s, MD and fellow researchers for exercise
testing and training concussed individuals is referred to as the Buffalo Concussion
Treadmill Test (BCTT). The BCTT protocol has two components:
1) Concussed patients are tested to the first sign of concussive symptom exacerbation
using the Balke exercise treadmill test to assess exercise tolerance. Treadmill speed is
set at 3.3 mph for the entirety of the test. Initially the treadmill incline is set to 0.0%.
After 1 minute, the incline is increased to 2.0%. At the start of the third minute, and each
minute after, the incline is increased by 1.0%. The rate of perceived exertion (RPE), by
use of the Borg Scale, and heart rate are recorded every minute. Blood pressure is
recorded every 2 minutes. The test is ended if the patient reports or shows signs of any
exacerbation of concussion symptoms, becomes too fatigued to continue, or if the
patient reaches the end of the test at 21 minutes.
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2) Patients are prescribed a progressive exercise program at 80% of their maximum
heart rate achieved subsymptom. Exercise is performed 20-30 minutes/day, 5 to 6
days/week. Patients are instructed to cease exercising if they experience any
exacerbation of concussion symptoms while exercising on a particular day. The
treadmill test should be used periodically, about every three weeks, during the treatment
episode to track the patient’s progression of concussion symptoms, and to adjust the
exercise prescription based upon the patient’s change in exercise tolerance.
The purpose of this literature review was to systematically review current
literature on subsymptom threshold treadmill testing and exercise training for treating
concussions and PCS. Specifically, this review focused on answering the PICO
question: Is subsymptom threshold exercise training a safe and effective treatment for
returning a 17 year old male athlete with postconcussion syndrome to sport?
Case Description
The patient was a 17 year old male high school junior who was concussed during
a football drill in early September 2014. The patient was experiencing prolonged
concussion symptoms resulting in a medical diagnosis of PCS. The patient presented
with headaches, neck pain, reduced cervical range of motion (ROM), dizziness, blurry
vision, tinnitus, disrupted sleep pattern, fatigue, depression, and difficulties with
concentration, memory and processing. The initial medical intervention for the patient
followed the stepwise Zurich Guidelines. The patient was not able to progress past
stage 1. In order for the patient to progress past stage 1 of the Zurich guidelines, the
patient must have reported being asymptomatic at rest for 24 hours with physical, and
cognitive rest. The patient’s prior medical history was insignificant with the exception of
7
one prior concussion experienced in 2012 during a football game, which the patient fully
recovered from, and returned to play two weeks later. The patient was 6’6” 308lbs. The
patient was referred to an outpatient concussion clinic at a large hospital in Idaho in late
October 2014.
The concussion clinic is comprised of a physician, a neuropsychologist, 2
physical therapists (orthopedic, and hearing & balance), an occupational therapist, a
speech language pathologist, and a social worker. In most cases, the individuals
referred to the concussion clinic have prolonged concussion symptoms lasting 3 weeks
or longer.
For the purposes of this paper, the focus of interventions provided to the patient
by the concussion clinic will be on those provided by the outpatient orthopedic physical
therapist. The physical therapist’s focus was to reduce cervical dysfunctions, reduce
cervicogenic headaches, and provide a prescription for exercises subthreshold to
symptoms using the BCTT protocol.
Examination
Date of initial visit: Late October 2014
Patient Information/History
Admitting diagnosis: Postconcussion syndrome 310.2
History of current illness: Patient is a 17 y/o who is experiencing prolonged concussion
symptoms. The patient currently reports daily headaches (L>R) with an intensity of 5/10
on a visual analog pain scale (VAS), which become worse (8/10 on the VAS) with
activities, and stimulation. Patient describes two types of headaches: cervicogenic
headaches starting from the neck and rolling over the sides and top of the head, and
8
traumatic headaches which located near the left frontal lobe where the head impact
occurred during the football drill. Neck pain persists, with reduced ROM. Patient’s upper
trap, and suboccipital muscles bilaterally are hypertonic. Patient indicates his upper trap
and suboccipital muscles bilaterally are the primary sources of his neck pain. Patient
stated his neck feels stiff in the morning, and the neck pain increases throughout the
day. Patient describes blurry vision, tinnitus, dizziness, disrupted sleep pattern, fatigue,
depression, and difficulties with concentration, memory and processing. Patient reports
using melatonin to help with getting more sleep.
Onset date: Patient was concussed during a football drill in early September 2014
Prior medical history: One prior concussion experienced in 2012 during a football game,
which the patient fully recovered from. No other significant prior medical history.
Past surgical history: None
Prior level of function: Independent with no pain or limitation in ambulation, ADL’s,
school or recreation
Social history: Patient lives with his mother in a single story house with no stairs. Patient
is a high school junior with a current grade point average of 3.5. Patient plays varsity
football and basketball. Patient’s mother is very supportive of him. Patient’s high school
principal, counselor, teachers, and coaches are supportive of the patient and his
recovery, temporarily reducing the patient’s school load and excusing him from athletic
activities. Whereabouts of patient’s father are unknown. Patient enjoys playing football
and basketball. Patient is motivated for a speedy recovery.
Primary language: English
Patient goal: To return to playing sports as soon as possible.
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Systems Review
Communication barriers: None
Cognitive status: Patient is alert and oriented to surroundings, time, and date
Vitals: HR 65 BP 110/66 Temp 98.0°F
Physical description: 6’6” 308lbs BMI 35.53
Tests and Measures
Posture: Forward head, anteriorly rotated shoulders
Cervical ROM: Slightly limited and painful with LSB and Lrot, all others WNL and
painfree
Shoulder ROM: All motions WNL and painfree
Cervical isometric strength testing in sitting: Flexion 4/5 painfree, Extension 4-/5 painful,
RSB 4-/5 painful, LSB 4-/5 painful, Rrot 4-/5 painful, Lrot 4-/5 painful
Shoulder MMT: For Flexion, Abduction, ER, IR bilaterally 5/5 and painfree
Myotome testing: C2-T1 all 5/5 bilaterally
Dermatome testing: UEs WNL to light touch bilaterally
Reflexes: UE DTRs (brachioradialis, biceps, and triceps tendons) 2/4 bilaterally,
Hoffman - bilaterally, clonus - bilaterally
Cervical compression and distraction tests in sitting + for symptom change (increase in
neck pain)
Alar ligament stability test normal
Transverse ligament test normal
Cervical segmental stability test normal
10
Palpation of cervical spine and surrounding musculature revealed multiple levels of mild
cervical joint dysfunctions with global soft tissue dysfunction. Bilaterally, the upper traps
and suboccipital musculature are hypertonic, and painful. The atlas, axis, and C5
cervical vertebrae all appear restricted in closing on left and opening on right, and
painful.
A treadmill test will be performed at patient’s next visit.
Evaluation
Medical diagnosis: Postconcussion syndrome ICD-9 code 310.2
PT diagnosis: Neck Pain, Cervicalgia ICD-9 code 723.1
Narrative assessment: Patient is a 17 y/o male who suffered a concussion on 9/8/14
during a football tackling drill. Patient was referred to PT for acute post-traumatic
headaches, cervicalgia, and for a subsymptom threshold treadmill test. The patient
presents with multiple PCS symptoms, which are preventing him from returning to his
prior level of functioning. Patient is a high school junior, living with his mother in a single
story home with no stairs. Patient has good family, and school personnel support.
Patient appears highly motivated for recovery. With professional PT services, the
patient should have a reduction in headache symptoms and neck pain, increased
cervical ROM, and increased tolerance for exercise without increase in his PCS
symptoms, in order to be able to successfully return to his prior level of functioning.
Patient has excellent rehabilitation potential to reach his prior level of function.
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Problem list
1) Multiple levels of mild cervical facet dysfunction
2) Neck pain
3) Persistent headaches
4) Generalized cervical musculature weakness
5) Forward head posture
Short-term goals
Patient will demonstrate independence with initial home exercise program for selfmanagement of care. (2 weeks)
Patient will report exercising most days of the week for at least 20 minutes/day at 80%
of maximum heart rate achieved subsymptom on the treadmill test in order to assist in
the overall recovery of PCS. (2 weeks)
Patient will demonstrate ability to find normal sitting posture while in PT visits with
minimal cues for correction in order to reduce the stain put on the cervical spine from
being in a forward head posture (2 weeks).
Long-term goals
Patient will transition to independent home exercise program for long-term, selfmanagement care. (4 weeks)
Patient will report performing prescribed exercises based on the BCTT protocol without
symptoms in order to be able to return to school and athletics full time. (4 weeks)
Patient will report resolution of cervicogenic headaches in order to be able to
concentrate effectively on schoolwork. (4 weeks)
12
Patient will demonstrate full, painfree, cervical AROM in order to be able to move head
in space painfree while performing everyday activities, such as driving, performing
schoolwork, and during athletics. (4 weeks)
Plan of care
Frequency and duration: 2 times a week for 4 weeks
PT interventions included postural education, cervicogenic headache reduction
education, subsymptom treadmill exercise testing based on the BCTT protocol,
subthreshold progressive exercises, cervical and upper back musculature strengthening
exercises and stretches, and manual therapy to the cervical spine.
Prognosis: Patient has a good prognosis to return to his prior level of functioning.
Patient is highly motivated for recovery. Patient is expected to be free of neck pain, free
of cervicogenic headaches, increased cervical ROM, increased tolerance for school and
athletic activities without increased symptoms in 4 weeks.
Rehabilitation prognosis: Excellent rehabilitation potential to reach prior level of function
Interventions
Patient was seen 2 days a week for 4 weeks with 30 minutes of PT per visit
except for treadmill testing, which was an hour session. During the first week of therapy,
the patient participated in a subsymptom threshold treadmill test following the BCTT
protocol. At the beginning of the treatment episode the patient’s sessions were focused
on manual therapy, postural education, and strengthening of the cervical musculature,
with emphasis placed on manual therapy. As the patient’s cervical dysfunctions
resolved, less emphasis was placed on manual therapy, and greater emphasis was
place on providing the patient with exercises for the neck and upper back. Every 2
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weeks the concussion team at the clinic would meet to discuss the patient’s progress,
and address any unforeseen issues.
Based upon the results of the subsymptom threshold treadmill test, the patient
was prescribed an aerobic exercise program to follow at home 20-30 minutes per day, 5
to 6 days a week, at 80% of his maximum heart rate achieved during the treadmill test
subsymptom (80% x 156 maximum heart rate = 125 beats per minute). The patient was
required to keep a daily exercise log, which showed the patient exercised most days of
the week by cycling an average of 20 minutes on stationary bike, and walking 30
minutes, while staying below 125 heart beats per minute. The patient was provided with
manual therapy to resolve cervical dysfunctions, and exercises to strengthen and
stabilize the patient’s cervical spine. Table 1 on pages 16-17 provides a summary of the
weekly interventions for the patient.
Outcomes
The patient made very good progress during his 4 weeks of outpatient physical
therapy. During the first week of therapy, the patient had persistent headaches ranging
in intensity on a pain scale from 5 to 8/10, decreased range of cervical range of motion,
neck pain, and fatigue. At the patient’s last visit, he displayed full cervical AROM,
reported no headaches in the past two days, no neck pain, and was able to cycle on a
stationary bike for 20 minutes without an increase in concussion symptoms. Patient was
able to meet all short and long-term goals during physical therapy. Patient was
discharged from physical therapy as he met all goals, showed enough progress to
transition to self-management of symptoms, and stated that he was ready to try selfmanagement. During concussion team meeting on the patient a week after his last
14
physical therapy appointment, the medical doctor assigned to his case said she would
release the patient to participate in athletics in two months if his progress continued.
The patient was able to return to athletics one month after discharge, progressing more
rapidly than his medical doctor initially predicted.
15
Table 1. Summary of interventions by week
Treatment
Category
Manual
Therapy
Week 1
Week 2
 Manual suboccipital release
 Global mobilization, grades
III-IV, to the cervical
 Global mobilizations, grades
III-IV, to the cervical uncinate
uncinate and facet joints
and facet joints bilaterally in
bilaterally in opening and
opening and closing
closing
 O/A and A/A distractions,
 O/A and A/A distractions,
grade IV
grade IV
Exercises
Provided in
Clinic
 Level I chin nods in supine
 Level II chin nods in supine
 Cervical side bending in
side lying
 Cervical wedge rotations in
supine
 Upper trap stretch
 Pectoralis corner stretch
HEP
Progression
 Level I chin nods in supine
 Level II chin nods in supine
 Prescribed cardio exercises
based upon 80% of 156 max
heart rate achieved
subsymptom = 125bpm
 Cervical side bending in
side lying
 Cervical wedge rotations in
supine
 Upper trap stretch
 Pectoralis corner stretch
16
Week 3
Week 4
 C5 restricted in closing on left
and opening on right, grade 5
manipulation administered
 Global mobilizations, grades
III-IV, to the cervical uncinate
and facet joints bilaterally in
opening and closing
 O/A and A/A distractions,
grade IV
 Global mobilizations, grades
III-IV, to the cervical uncinate
and facet joints bilaterally in
opening and closing
 O/A and A/A distractions,
grade IV
 Cervical side bending in side
lying
 Cervical wedge rotations in
supine
 Shoulder/upper back
exercises with Theraband for
resistance: rows, external
rotation, and horizontal
abduction
 Pectoralis corner stretch
causing patient pain, changed
to unilateral door stretch
 Shoulder/upper back
exercises with Theraband for
resistance: rows, external
rotation, and horizontal
abduction
 Pectoralis unilateral door
stretch
 HEP given up to this point
reviewed in entirety to assure
patient independence
 Incline diagonal chin nods
 Incline diagonal chin nods
Subthreshold
Treadmill Test
Results
 Posture
 Helmet safety
 Research related to repeated
concussions and long term
 Posture continued to be
results
addressed
 Results of BCTT, instructed
 Self subocciptal release in
 Weight training with low level
on how to find pulse, and
supine with 2 tennis balls
weights, increased repetitions,  Research on concussion
cardio exercises to be
taped together placed under
and avoiding concussion
progression and return to
perform subthreshold
suboccipitals
symptoms
play
 Resting heart rate 71 blood
pressure 110/76
 Patient performed BCTT 11
minutes to heart rate 156
 Patient reports cycling 20
 BCTT discontinued due to
minutes on stationary bike,
increase in headache
 Patient reports cycling 10 Patient reports cycling 15-20
walking 30 minutes everyday,
 Prescribed cardio exercises
15 minutes on stationary
minutes on stationary bike
and beginning weight training
based upon 80% of 156 max
bike and walking 30 minutes
and walking 30 minutes
with low weight high
HR achieved subsymptom =
everyday making sure to
everyday making sure to stay
repetitions, while making
125bpm
stay below 125bpm
below 125bpm
sure to stay below 125bpm
Patient Staffed
in Concussion
Team
Conference
Yes
Significant
Changes in
Symptoms
 No significant changes this
week
Education
Provided
No
 Less neck pain
 Able to look over shoulder
without spike in pain
 Decrease in headache
intensity
17
Yes
 Cervical AROM WNL
 Fewer cervical dysfunctions
found with palpation this week
No
 No headaches experienced
in 2 days
 No cervical dysfunctions
found with palpation
 No neck pain
Evidence Based Analysis
PICO question: Is subsymptom threshold exercise training a safe and effective
treatment for returning a 17 year old male athlete with postconcussion syndrome to
sport?
Methodology of search
The databases used for key word searches were PubMed, Cochrane, and
CINAHL. Google Scholar was used in order to find supporting articles cited in the
articles reviewed.
Four searches were performed on each of the PubMed, Cochrane, and CINAHL
databases using the following key terms: treadmill testing concussion, exercise testing
concussion, treadmill training concussion, and exercise training concussion. The results
of each of these key term searches are displayed in figure 1 in the appendix.
Accounting for duplicates of the articles found between the databases, articles were
included in this literature review if the title and abstract of the article related to results
found on treadmill testing concussed individuals.
In all 15 articles were initially found to be relevant. However, upon further review
of the articles’ contents, 9 articles specifically addressed treadmill testing concussed
individuals, contained enough information to help answer the PICO question, and were
deemed as the primary articles to be used in this literature review. Six articles were
excluded from the primary literature review due to not being specifically relevant to
treadmill testing concussed individuals. The 6 excluded articles contained information
on concussed individuals such as heart rate, the autonomic nervous system, exercise,
and the pediatric population. As this information was deemed supplemental to the
18
primary literature review, the excluded articles were used as supporting articles rather
than primary sources. Some, but not all, of the supporting articles were referenced in
this literature review.
Summaries of the primary articles reviewed are available on pages 21-29 in
order of the primary author’s name. Evidence appraisal worksheets on the primary
articles used are available on pages 34-82 in order of the primary authors name.
Google Scholar was used to find two supporting articles cited in the primary
articles reviewed
Primary articles reviewed
Baker, J. G., Freitas, M. S., Leddy, J. J., Kozlowski, K., & Willer, B. S. (2012). Return to
full functioning after graded exercise assessment and progressive exercise treatment
of postconcussion syndrome. Rehabilitation Research and Practice, 2012, 1-7.
Darling, S. R., Leddy, J. J., Baker, J. G., Williams, A. J., Surace, A., Miecznikowski, J.
C., & Willer, B. (2014). Evaluation of the Zurich Guidelines and exercise testing for
return to play in adolescents following concussion. Clinical Journal of Sport
Medicine, 24(2), 128-133.
Kozlowski, K., Graham, J., Leddy, J. J., Devinney-Boymel, L., & Willer, B. S. (2013).
Exercise intolerance in individuals with postconcussion syndrome. Journal of Athletic
Training, 48(5), 627-635.
Leddy, J. J., Baker, J. G., Kozlowski, K., Bisson, L., & Willer, B. (2011). Reliability of a
graded exercise test for assessing recovery from concussion. Clinical Journal of
Sport Medicine, 21(2), 89-94.
Leddy, J. J., Cox, J. L., Baker, J. G., Wack, D. S., Pendergast, D. R., Zivadinov, R., &
Willer, B. (2013). Exercise treatment for postconcussion syndrome: A pilot study of
changes in functional magnetic resonance imaging activation, physiology, and
symptoms. The Journal of Head Trauma Rehabilitation, 28(4), 241-249.
Leddy, J. J., Kozlowski, K., Donnelly, J. P., Pendergast, D. R., Epstein, L. H., & Willer,
B. (2010). A preliminary study of subsymptom threshold exercise training for
refractory post-concussion syndrome. Clinical Journal of Sport Medicine, 20(1), 2127.
19
Leddy, J. J., Sandhu, H., Sodhi, V., Baker, J. G., & Willer, B. (2012). Rehabilitation of
concussion and post-concussion syndrome. Sports Health: A Multidisciplinary
Approach, 4(2), 147-154.
Leddy, J. J., & Willer, B. (2013). Use of graded exercise testing in concussion and
return-to-activity management. Current Sports Medicine Reports, 12(6), 370-376.
Makdissi, M., Cantu, R. C., Johnston, K. M., McCrory, P., & Meeuwisse, W. H. (2013).
The difficult concussion patient: what is the best approach to investigation and
management of persistent (> 10 days) postconcussive symptoms?. British Journal of
Sports Medicine, 47(5), 308-313.
Articles excluded from the primary review
Blake, T., McKay, C., Meeuwisse, W. H., & Emery, C. (2014). The impact of concussion
on cardiac autonomic function: A systematic review of evidence for recovery and
prevention. British journal of sports medicine, 48(7), 569-569.
Conder, R. L., & Conder, A. A. (2014). Heart rate variability interventions for concussion
and rehabilitation. Frontiers in Psychology, 5, 1-7.
Halstead, M. E., & Walter, K. D. (2010). Sport-related concussion in children and
adolescents. Pediatrics, 126(3), 597-615.
Kozlowski, K. (2014). Exercise and Concussion, Part 1: Local and systemic alterations
in normal function. International Journal of Athletic Therapy & Training, 19(2), 23-27.
Kozlowski, K. (2014). Exercise and Concussion, Part 2: Exercise as a therapeutic
intervention. International Journal of Athletic Therapy & Training, 19(2), 28-32.
McCrory, P., Meeuwisse, W. H., Aubry, M., Cantu, B., Dvořák, J., Echemendia, R. J.,
Engebretsen, L., Johnston, K., Kutcher, J. S., Raftery, M., Sills, A., Benson, B. W.,
Davis, G. A., Ellenbogen, R. G., Guskiewicz, K., Herring, S. A., Iverson, G. L.,
Jordan, B. D., Kissick, J., McCrea, M., McIntosh, A. S., Maddocks, D., Makdissi, M.,
Purcell, L., Putukian, M., Schneider, S., Tator, C. H., & Turner, M. (2013).
Consensus statement on concussion in sport: the 4th International conference on
concussion in sport held in Zurich, November 2012. British Journal of Sports
Medicine, 47, 250-258.
Tan, C. O., Meehan, W. P., Iverson, G. L., & Taylor, J. A. (2014). Cerebrovascular
regulation, exercise, and mild traumatic brain injury. Neurology, 83(18), 1665-1672.
20
Baker, J. G., Freitas, M. S., Leddy, J. J., Kozlowski, K., & Willer, B. S. (2012). Return to
full functioning after graded exercise assessment and progressive exercise treatment
of postconcussion syndrome. Rehabilitation Research and Practice, 2012, 1-7.
Level of Evidence: 2b, Retrospective cohort study
Purpose: To show functional outcomes of those with postconcussion syndrome (PCS)
when prescribed a progressive subsymptom threshold exercise program.
Methods: Ninety-one subjects with PCS (3 or more concussion symptoms lasting
longer than 3 weeks) were split into two different groups based upon the results of a
graded exercise assessment: Sixty-five subjects were placed in the physiological PCS
(P-PCS) group due to physiological exacerbation of symptoms; 26 subjects exercised to
maximum capacity without exacerbation of symptoms. All subjects were offered a
graduated exercise program, 6 declined (5 P=PCS, and 1 PCS). The exercise program
was individualized based upon heart rate during the assessment. Two years post injury
a telephone follow-up survey was administered to assess the final functional outcome:
Forty P-PCS and 23 PCS group participants, including those who declined the exercise
program, were reached.
Results: Of those who could be reached for the follow-up survey: Twenty-seven (77%)
P-PCS and 14 (64%) PCS group participants who participated in the exercise program
returned to their prior level of functioning. Of those who declined to participate in the
exercise program 1 (20%) returned to their prior level of functioning.
Bottom Line: Individualized progressive exercise treatment appears to be useful in
returning PCS subjects to their prior level of functioning.
21
Darling, S. R., Leddy, J. J., Baker, J. G., Williams, A. J., Surace, A., Miecznikowski, J.
C., & Willer, B. (2014). Evaluation of the Zurich Guidelines and exercise testing for
return to play in adolescents following concussion. Clinical Journal of Sport
Medicine, 24(2), 128-133.
Level of Evidence: 2b, Retrospective cohort study
Purpose: To evaluate return to play (RTP) decision outcomes made from a
combination of the Buffalo Concussion Treadmill Test (BCTT) and Zurich guidelines.
The secondary purpose was to determine if a computerized neuropsychological test
(cNP) predicted new or increased learning problems in the classroom.
Methods: Adolescent athletes diagnosed with a concussion and referred to a
concussion clinic between 2010 and 2012 were eligible to be included in the
retrospective chart review and phone survey follow-up study. Ninety-one of 117
potential subjects were available for follow-up and included in the study. The subjects
received pre- and post BCTTs and post cNP testing. The phone follow-up inquired if the
subjects experienced any concussion related symptoms affecting their athletics or
schooling after being deemed asymptomatic.
Results: All subjects returned to sport a week after successfully completing the BCTT
and progressing through the stepwise Zurich guidelines. About 39% reported new or
increased problems in the classroom after being cleared to return. cNP testing was not
proven to be significant in predicting RTP success or predicting new or increased
learning problems in the classroom.
Bottom Line: The BCTT in combination with the Zurich guidelines are reliable methods
to in determining RTP in concussed adolescent athletes. The cNP testing did not prove
significant with predicting RTP or future learning difficulties.
22
Kozlowski, K., Graham, J., Leddy, J. J., Devinney-Boymel, L., & Willer, B. S. (2013).
Exercise intolerance in individuals with postconcussion syndrome. Journal of Athletic
Training, 48(5), 627-635.
Level of Evidence: 2b, Individual inception cohort study with > 80% follow-up
Purpose: To assess exercise intolerance in patients with postconcussion syndrome
(PCS) as seen by increases in concussion symptoms during treadmill testing.
Methods: Two groups of subjects, PCS group and control group, were compared
against during graduated treadmill testing for duration, heart rate, rate of perceived
exertion (RPE) through the Borg Scale, systolic blood pressure [BP], and diastolic BP.
The PCS group consisted of 34 subjects diagnosed with PCS. The control group
consisted of 22 healthy subjects, no previous history of head injuries. Both groups
completed the graduated treadmill test. The test was ended for any individual if they
became too fatigued to continue, if any subject in the PCS group began to experience
any exacerbation in concussion symptoms, or if the individual reached the end of the
test at 21 minutes.
Results: The PCS group subjects had significantly decreased tolerance to the treadmill
test than their healthy counterparts. The PCS group participants had significantly
reduced testing duration (9.4 minutes less on average, P<0.001), max heart rate
(P<0.001), max systolic BP (P=0.02), and max diastolic BP (P=0.03).
Bottom Line: From the systemic evidence quantified form this study, patients with PCS
maybe able to safely participate in exercises at a low-levels (<75% age predicted max
heart rate). However, the exercise prescription should be individualized based on
results from a graduated treadmill test.
23
Leddy, J. J., Baker, J. G., Kozlowski, K., Bisson, L., & Willer, B. (2011). Reliability of a
graded exercise test for assessing recovery from concussion. Clinical Journal of
Sport Medicine, 21(2), 89-94.
Level of Evidence: 1b, Individual inception cohort study with > 80% follow-up
Purpose: To assess the retest reliability (RTR) of a standardized graded treadmill
exercise test in determining return to play (RTP) status of both concussed athletes and
nonathletes.
Methods: Twenty-one subjects (11athletes and 10 non-athletes) experiencing
concussion symptoms ≥6 weeks but <52 weeks referred consecutively to a concussion
clinic, and 10 control subjects (no history of concussions and sedentary for the past 6
weeks) performed 2 incremental treadmill exercise tests 2 to 3 weeks apart. The
treadmill test followed the Balke protocol to the first sign of concussive symptom
exacerbation. “The treadmill speed was set at 3.3 mph at 0.0% incline. After 1 minute,
the grade increased to 2.0% while maintaining the same speed. At the start of the third
minute and each minute thereafter, the grade increased by 1.0%, maintaining the speed
at 3.3 mph.” RPE and heart rate were recorded every minute with BP being recorded
every 2 minutes.
Results: RTR for the treadmill test revealed maximal heart rate to have good RTR and
moderate RTR for maximal SBP. DBP proved to not be a reliable reproducible
measurement.
Bottom Line: The Balke exercise treadmill test for symptom identification in concussed
patients has “sufficient maximum heart rate RTR,” and appears to be a more reliable
method for tracking the progress of athletes trying to RTP than the stepwise program,
which is subjective. Further studies need to be performed.
24
Leddy, J. J., Cox, J. L., Baker, J. G., Wack, D. S., Pendergast, D. R., Zivadinov, R., &
Willer, B. (2013). Exercise treatment for postconcussion syndrome: A pilot study of
changes in functional magnetic resonance imaging activation, physiology, and
symptoms. The Journal of Head Trauma Rehabilitation, 28(4), 241-249.
Level of Evidence: 1b, Individual RTC
Purpose: To compare fMRI results between subjects with PCS who received an
exercise program, subjects with PCS who received a placebo intervention, and a
healthy control group.
Methods: The PCS exercise group (n=4) were prescribed exercises 20 minutes/day,
6days/week, at an intensity of 80% of max HR achieved subsymptom found via
treadmill testing. The PCS placebo group (n=4) received a sham-stretching program (20
minutes/day 6 days/week) and instructed not to exceed 40%-50% of their age predicted
max HR. The control group (n=4) was comprised of healthy subjects, matched to the
demographics of the PCS subjects. fMRI results were compared before treatment and
12 weeks later.
Results: fMRI results before treatment: No difference between the exercise and
placebo PCS groups, the control group had greater activation in the posterior cingulate
gyrus, lingual gyrus, and cerebellum. fMRI results after treatment: No differences
between the exercise PCS group and the control group, the placebo PCS group had
significantly (P<0.05) less cerebellar activity.
Bottom Line: A prescribed progressive aerobic exercise program, as described in the
methods sections, appears beneficial in the recovery from PCS and appears to help
restore cerebral blood flow regulation.
25
Leddy, J. J., Kozlowski, K., Donnelly, J. P., Pendergast, D. R., Epstein, L. H., & Willer,
B. (2010). A preliminary study of subsymptom threshold exercise training for
refractory post-concussion syndrome. Clinical Journal of Sport Medicine, 20(1), 2127.
Level of Evidence: 1b, Individual inception cohort study with > 80% follow-up
Purpose: To show the safety and effectiveness of reducing concussive symptoms in
individuals with PCS through the implementation a progressive subsymptom threshold
exercise training (SSTET) program.
Methods: Twelve subjects experiencing PCS referred consecutively to a concussion
clinic participated. Subjects performed 2 treadmill exercise tests 2 to 3 weeks apart. The
treadmill test followed the Balke protocol to the first sign of concussive symptom
exacerbation. RPE and HR were recorded every minute, with BP being recorded every
2 minutes. Subjects were prescribed exercises at the intensity of 80% of max HR
achieved subsymptom, 1x/day, 5 to 6 days/week. Symptoms were recorded before
exercising using the Graded Symptom Checklist (GSC). Exercise was terminated at first
sign of symptom exacerbation. Treadmill testing was performed every 3 weeks until all
symptoms resolved. A phone follow-up survey was administered 3 months after
symptom resolution.
Results: All 12 subjects followed the exercise prescription with no adverse reactions.
Significant differences: Baseline and end treatment GSC (P=0.002), exercise duration
increased significantly (P=0.001), and peak heart rate and SBP with exercise increase
significantly (both P<0.001). The phone follow-up revealed all subjects completely
returned to work, school, and athletic activities.
Bottom Line: Individualized progressive SSTET appears to be safe and assists in the
recovery of PCS.
26
Leddy, J. J., Sandhu, H., Sodhi, V., Baker, J. G., & Willer, B. (2012). Rehabilitation of
concussion and post-concussion syndrome. Sports Health: A Multidisciplinary
Approach, 4(2), 147-154.
Level of Evidence: 2a, Systematic Review of cohort studies, retrospective cohort
studies, and Level 2b and better studies
Purpose: To review available literature on recommendations for rehabilitation of
concussion and postconcussion syndrome (PCS).
Methods: The authors used broad protocols to gather all currently available literature
for the systematic review. Databases used were: MEDLINE and PubMed. Key terms
used were: “brain concussion/ complications OR brain concussion/ diagnosis OR brain
concussion/ therapy AND sports OR athletic injuries. Secondary search terms included:
post-concussion syndrome, trauma, symptoms, metabolic, sports medicine, cognitive
behavioral therapy, treatment and rehabilitation. Additional articles were identified from
the bibliographies of recent reviews.”
Results: Of the initial 564 articles found, 119 were chosen for inclusion in the study as
they focused on the “diagnosis, pathophysiology, and treatment/ rehabilitation of
concussion and PCS.”
Bottom Line: Prolonged rest for patients diagnosed with PCS has not proven to be
beneficial. Aerobic exercise therapy, cognitive behavioral therapy and early education
have show to be effective treatment methods. Treatment methods need to be
individualized for patients with PCS.
27
Leddy, J. J., & Willer, B. (2013). Use of graded exercise testing in concussion and
return-to-activity management. Current Sports Medicine Reports, 12(6), 370-376.
Level of Evidence: 3a, Systematic Review of 3b and better studies
Purpose: “To review the use of exercise testing to evaluate physiologic recovery from
the acute effects of concussion and to review the theory and evidence behind using
individualized aerobic exercise treatment in the return-to-activity (RTA) management of
those with concussion and post concussion syndrome.”
Methods: This was a systematic review of literature. 50 studies were cited as being
used for this article. Inclusion/exclusion of studies used were not discussed, nor was
how the search for studies was performed.
Results: Data for the studies presented in the article, sparse as it was, was
homogeneous.
Bottom Line: The Buffalo Concussion Treadmill Test (a slight variation on the Balke
exercise treadmill test) appears safe and should be used to establish an individualized
exercise duration and intensity, and be used throughout the treatment phase in order to
monitor the patient’s symptoms and tolerance of exercise. Individualized progressive
subsymptom threshold exercise training appears to be safe and expedites the recovery
of PCS.
28
Makdissi, M., Cantu, R. C., Johnston, K. M., McCrory, P., & Meeuwisse, W. H. (2013).
The difficult concussion patient: what is the best approach to investigation and
management of persistent (> 10 days) postconcussive symptoms?. British Journal of
Sports Medicine, 47(5), 308-313.
Level of Evidence: 2a, Systematic Review of cohort studies, retrospective cohort
studies, and Level 2b and better studies
Purpose: To review available literature on recommendations for management of
concussions symptoms lasting > 10 days.
Methods: The authors used broad protocols to gather all currently available literature
for the systematic review. Databases used were: MEDLINE, ISI Web of Science,
PubMed, and SportDiscus. Key words used were: concussion, mild traumatic brain
injury, head injury and sport or athlete/athletic. The key words were combined with
terms which would limit the search to difficult to resolve concussions and management
of them: symptoms, complex, difficult, prolonged, persistent, post-concussion
syndrome, investigation, imaging, biomarker, gene/genetic, treatment, medication,
management, exercise and rehabilitation. “Reference lists from retrieved articles were
searched for additional articles, and the authors’ own collections of articles were
included in the search strategy.”
Results: The authors did not disclose the number of articles included in the study or
inclusion/exclusion criteria. The reference page included 68 articles.
Bottom Line: Controversial to dated studies (>10 years old), prolonged rest has not
proven beneficial in the treatment of prolonged concussion symptoms. Providing a
subsymptom exercise prescription along with a combination of other treatments such as
vestibular, physical, manual, cognitive, and psychological therapy are beneficial in the
treatment of concussions.
29
Discussion
Six weeks after being concussed, the patient was continuing to experience more
than 3 concussion related symptoms classifying him as having PCS. Most individuals
who experience a concussion have spontaneous resolution of symptoms within 7 to 10
days (Leddy et al., 2010). The Zurich guidelines are the most commonly used method
for tracking and treating individuals in their quest to return to play or work. However, the
creators of the Zurich guidelines are the first to state their guidelines have not yet been
proven to be a reliable, outcome based method for returning individuals to work or sport
(McCrory et al., 2013). Subsymptom threshold treadmill testing and exercise training
has proven to be a safe, reliable, and effective method in treating individuals with
prolonged concussion symptoms for returning to work and sport (Baker, Freitas, Leddy,
Kozlowski, & Willer, 2012; Darling et al., 2014; Kozlowski et al., 2013; Leddy et al.,
2010; Leddy, Baker, Kozlowski, Bisson, & Willer, 2011; Leddy et al., 2012; Leddy &
Willer, 2013; Leddy et al., 2013).
Prior to being referred to the concussion clinic, the patient’s medical caregivers
were following the Zurich guidelines solely for 6 weeks, and prescribed the patient
prolonged rest. As the authors of the Zurich guidelines state, the guidelines are yet to
be proven an effective method for RTP following a concussion (McCrory et al., 2013).
Prolonged rest for individuals diagnosed with PCS has not been proven to be beneficial
(Leddy et al., 2012; Makdissi, et al., 2013). The evidence based research on the BCTT
protocol proves significantly that patients with prolonged concussion symptoms benefit
from this methodology for RTP (Baker et al., 2012; Darling et al., 2014; Leddy et al.,
2010). The evidence based research seems to show that the use of the Zurich guideline
30
is an unproven method, while the BCTT protocol is a proven method. The “Guide to
Physical Therapist Practice” by the American Physical therapy Association (2001)
reminds us that physical therapy practice must be based on evidence based research,
clinical experience and patient values. Although the Zurich guidelines have not
experimentally been proven to be a reliable method for recovery from concussions
(McCrory et al., 2013), clinical experience by clinicians around the world supports the
implementation of the Zurich guidelines for tracking of the concussed patient’s
symptoms for RTP. The opinion of this author is to treat concussed patients with a
combination of the BCTT protocol and the Zurich guidelines. Darling et al. (2013)
proved the combination of these two methodologies is beneficial in returning concussed
patients to sport.
The patient received the combination of the BCTT protocol and Zurich guidelines.
The medical doctor on the concussion team managed the patient through the Zurich
guidelines, while the physical therapist implemented the BCTT protocol. The patient
was discharged successfully from physical therapy at the end of November 2014. At of
the beginning of January 2015, the patient returned to play without residual concussion
symptoms.
The literature review revealed the BCTT protocol is a newer methodology used in
the treatment of concussions. More research is needed to continue to prove its efficacy,
and to expand on the results from previous studies. The literature review on the BCTT
protocol revealed the need to compare a statistically significant number of individuals
diagnosed with PCS, randomized in two groups, with one group receiving the BCTT
31
protocol, and the other receiving the Zurich guidelines protocol, with the dependent
variable being RTP, in order to compare RTP results of these two methodologies.
Conclusion
Acutely concussed individuals are thought to have decreased cerebral
autoregulation affecting cerebral blood flow, which can cause an exacerbation of
concussion symptoms with exercise (Leddy et al., 2012; Tan, Meehan, Iverson, &
Taylor, 2014). While rest is emphasized in the first stage of the Zurich guidelines, some
concussed individuals with prolonged concussion symptoms have difficulty moving past
this stage. However, prolonged rest for individuals diagnosed with PCS has not been
proven to be beneficial (Leddy et al., 2012; Makdissi, et al., 2013). Subsymptom
threshold treadmill testing and exercise training has proven to be a safe, reliable, and
effective method in treating individuals with prolonged concussion symptoms (Baker,
Freitas, Leddy, Kozlowski, & Willer, 2012; Darling et al., 2014; Kozlowski et al., 2013;
Leddy et al., 2010; Leddy, Baker, Kozlowski, Bisson, & Willer, 2011; Leddy et al., 2012;
Leddy & Willer, 2013; Leddy et al., 2013). Research has shown the majority of
concussed individuals who have participated in subsymptom threshold treadmill testing
and exercise training protocols return to their prior level of functioning, work and sport
(Baker et al., 2012; Darling et al., 2014; Leddy et al., 2010), and show recovery of brain
activity (Leddy et al., 2013).
Bottom Line
Subsymptom threshold treadmill testing and exercise training is a safe, reliable,
and effective method in treating patients with prolonged concussion symptoms for return
to work and sport.
32
Name: David Scussel
Prognostic Study – Evidence Appraisal Worksheet
Citation (use AMA or APA format):
Baker, J. G., Freitas, M. S., Leddy, J. J., Kozlowski, K., & Willer, B. S. (2012).
Return to full functioning after graded exercise assessment and progressive
exercise treatment of postconcussion syndrome. Rehabilitation Research and
Practice, 2012, 1-7.
Level of Evidence (Oxford scale): 2a, Retrospective cohort study
Is the purpose and background information sufficient?
Appraisal Criterion
Study Purpose
Reader’s Comments
Yes, the purpose of the study was stated
clearly within the article. The purpose of
Stated clearly?
Usually stated briefly in abstract and in greater the study was to show functional outcomes
(i.e. return to work, athletic activities, and
detail in introduction. May be phrased as a
other ADLs) of those with postconcussion
question or hypothesis.
A clear statement helps you determine if topic syndrome (PCS) when prescribed a
progressive subsymptom threshold
is important, relevant and of interest to you.
exercise program.
Consider how the study can be applied to PT
and/or your own situation. What is the
purpose of this study?
Yes, relevant background research is
Literature
presented. The authors justify the need for
Relevant background presented?
this study by stating although “concussion
A review of the literature should provide
management has been moving toward an
background for the study by synthesizing
individualized, patient-centered approach
relevant information such as previous
research and gaps in current knowledge, along to assessment and treatment, and more
athletes and nonathletes are being treated
with the clinical importance of the topic.
at specialized concussion clinics… very
Describe the justification of the need for this
little outcomes research has been
study
conducted on the effectiveness of
treatment for concussion.”
Does the research design have strong sampling techniques?
Appraisal Criterion
Did the investigators provide sufficient
information to describe the sample in their
study?
Does the study clearly define the group
of patients; is there a clear inclusion
and exclusion criterion? Is there a clear
description of the stage and timing of
Reader’s Comments
Yes, the authors described the population
sample in their study well.
Inclusion criteria including stage and
timing of the injury: A retrospective chart
review of patients who were referred for
PCS symptoms (experiencing > 3
persistent symptoms at rest for a period >
33
the problem (illness) studied.
3 weeks as a result of a concussion) to the
University at Buffalo Sports Medicine
Concussion Clinic between 2007 and 2009
who returned for an exercise assessment
were included in the study.
Exclusion criteria: Must meet inclusion
criteria, comorbidities and demographics
not a factor for exclusion.
Yes, all eligible PCS patients who were
referred and completed an exercise
assessment at the University at Buffalo
Sports Medicine Concussion Clinic
between 2007 and 2009 were included in
the study.
Are the subjects representative of the
population from which they were drawn?
Did they capture all eligible subjects?
Are the results of this prognostic study valid?
Appraisal Criterion
1.
2.
3.
Were the subjects assembled at a common
(usually early) point in the course of their
disorder?
a. If not, what are the implications of
multiple starting points for this study’s
results?
Was the study time frame long enough to
capture the outcome(s) of interest? Was
patient follow-up sufficiently long and
complete?
a. If not, what are the potential
consequences of the follow-up time
for the study’s results?
Did all subjects originally enrolled complete
the study?
a. If not, how many subjects were lost
b. What if anything did the authors do
about this attrition?
c. What are the implications of this
attrition and the way it was handled
with respect to the study’s findings?
Reader’s Comments
The commonality between the subjects’
injuries was being referred to the
University at Buffalo Sports Medicine
Concussion Clinic between 2007 and 2009
for PCS and subsequently participating in
an exercise assessment. Subjects were
reached via phone for a follow-up survey
at an average of 2 years post injury (range
= 4 to 73 months).
Yes, the time frame of the study was long
enough to capture the subjects’ function
outcome results. Subjects were reached
via phone for a follow-up survey at an
average of 2 years post injury (range = 4
to 73 months).
Of the 91 subjects who initially met the
criteria to be in the retrospective chart
review, 63 were available for a follow-up
survey of functional outcomes results.
Reduction of group size is expected during
a retrospective long-term (average of 2
years) follow-up study. This study was
able to follow-up with 69% of the subjects
initially included. The authors do state
although there were not differences in
demographic information between the
participants who were able to be reached
for follow-up and those who were not
34
4.
Were objective outcome criteria applied to the
subjects in a masked or blinded fashion??
a. If not, what are the potential
consequences for this study’s results
5.
If subgroups with different prognoses are
identified, was there adjustment for important
prognostic or risk factors?
a. If not, what should have been
included? What are the potential
consequences for the lack of this
adjustment
6.
Was there an independent set of patients to
validate the study?
a. If not, what are the potential
consequences for this study’s results?
available, due to the mall sample size
there could have been difference between
these two groups. The authors state the
results for this pilot study indicates “the
need for further study.”
Subjects were not randomized or blinded
in any fashion. As this was a retrospective
follow-up study based on a chart review
blinding was not necessary. However,
future prospective studies hoping to
replicate and elaborate upon the results of
this study need to implement
randomization and blinding of subjects,
and blinding of the researcher performing
the follow-up survey in order to make the
study’s results of greater significance. I do
not see how a researcher could be blinded
during the subjects’ treatment, as a POC
with exercise as opposed to without
exercise would be obvious.
Different subgroups were identified and
separated into two groups: Sixty-five
patients were placed in the physiological
PCS (P-PCS) group due to physiological
exacerbation of symptoms; 26 patients
exercised to maximum capacity without
exacerbation of symptoms.
All subjects were followed-up with the
same survey for functional outcomes.
Although the precaution of separating the
two groups was implemented, no
significant difference was found between
the groups. Only those who declined to
participate in an exercise program showed
a significant difference fro those who had
accepted.
There was no control group in this
retrospective chart review. Not having a
control group in this case decreased the
potential sample size and the relative
impact of the study’s results. A future
prospective study with a control group
should be implemented to valid the study’s
findings and to elaborate upon the results.
Are the valid results of this prognostic study important?
Appraisal Criterion
Reader’s Comments
35
7.
What were the statistical findings of this
study?
a. When appropriate use the calculation
forms below to determine these
values
b. Report on correlation coefficient
and/or coefficient of determination
c. Did they include a survival curve, ROC,
odds ratios, relative risk ratio
d. How precise are the CIs?
e. Other stats should be included here
8.
What is the meaning of these statistical
findings for your patient/client’s case? What
does this mean to your practice?
a, b, c, d  N/A
e. The chi-square test or Fischer’s exact
test for small samples was used when
comparing categorical variables between
groups. Independent sample t-tests for
continuous variables. Step-wise logistic
regression analysis of the descriptive
statistics was performed.
“A significance level of P < 0.05 was used
throughout the statistical comparisons, and
in the step-wise logistic regression
analysis.”
No significant demographic differences
were found between groups.
The P-PCS group displayed significantly
more headaches (P < 0.02) and greater
fatigue (P < 0.01) than the PCS group.
Significantly (P < 0.02) those who
participated in an exercise program
returned to their prior level of functioning
compared to those who declined to
participate in an exercise program.
Individualized progressive exercise
treatment appears to be useful in returning
PCS patients to their prior level of
functioning.
Can you apply this valid, important evidence about this prognostic
study in caring for your patient/client? What is the external validity?
Appraisal Criterion
9.
How likely are these outcomes over time?
10. Are the study subjects similar to your patient/
client?
a. If not, how different? Can you use this
test in spite of the differences?
11. Would sharing this information help your
patient/client given their expressed values and
preferences?
Reader’s Comments
Although more studies must be taken into
account, it appears implementing an
exercise program for the PCS population
can help to return them to their prior level
of functioning.
The study subjects did not differ in
average demographic statistics when
compare to the concussed population I
have seen in clinic to date.
Educating my patients is key to helping
them buy into any treatment I provide
them. The information and results fro this
study would help the patient make an
informed decision when debating whether
to accept a therapeutic exercise program
or not.
36
What is the bottom line?
Appraisal Criterion
Summarize your findings and relate this back to clinical
significance and usefulness of this study
Reader’s Comments
Significantly (P < 0.02) those who
participated in an exercise program
returned to their prior level of
functioning compared to those who
declined to participate in an
exercise program.
Bottom Line: Individualized
progressive exercise treatment
appears to be useful in returning
PCS patients to their prior level of
functioning.
37
Name: David Scussel
Intervention – Evidence Appraisal Worksheet
Citation (use AMA or APA format):
Darling, S. R., Leddy, J. J., Baker, J. G., Williams, A. J., Surace, A.,
Miecznikowski, J. C., & Willer, B. (2014). Evaluation of the Zurich Guidelines
and exercise testing for return to play in adolescents following concussion.
Clinical Journal of Sport Medicine, 24(2), 128-133.
Level of Evidence (Oxford scale):
2b, Retrospective cohort study
Is the purpose and background information sufficient?
Appraisal Criterion
Study Purpose
Reader’s Comments
To evaluate return to play (RTP) decision
Stated clearly?
outcomes made from a combination of the
Usually stated briefly in abstract and in greater Buffalo Concussion Treadmill Test (BCTT)
and Zurich guidelines. The secondary
detail in introduction. May be phrased as a
purpose was to determine if a
question or hypothesis.
A clear statement helps you determine if topic computerized neuropsychological test
(cNP) predicted new or increased learning
is important, relevant and of interest to you.
problems in the classroom.
Consider how the study can be applied to PT
and/or your own situation. What is the
purpose of this study?
Literature
Relevant background presented?
A review of the literature should provide
background for the study by synthesizing
relevant information such as previous
research and gaps in current knowledge, along
with the clinical importance of the topic.
Describe the justification of the need for this study
Yes, background information was
presented stating the BCTT has been
proven reliable and successful in RTP
methods after being concussed. However,
the Zurich guidelines used by itself has not
been tested for outcomes. Much hype has
surrounded cNP testing for concussed
subjects but its reliability and utility has
come into question.
Does the research design have strong internal validity?
Appraisal Criterion

Discuss possible threats to internal validity in
the research design. Include:
 Assignment
 Attrition
 History
 Instrumentation
Reader’s Comments
Assignment: Adolescent athletes
diagnosed with a concussion and referred
to a concussion clinic between 2010 and
2012 were eligible to be included in the
retrospective chart review and phone
survey follow-up study. Ninety-one of 117
38





Maturation
Testing
Compensatory Equalization of
treatments
Compensatory rivalry
Statistical Regression
potential subjects were available for followup and included in the study. In order to
get a large sample size of concussed
adolescent athletes a retrospective chart
review was performed. The large number
(91) of subjects decreases the risk to
internal validity.
Attrition: All subjects (91) who were
available for a follow-up phone survey
completed the study.
History: The authors addressed the
history and progress of identifying
concussions,
Instrumentation: The subjects received
pre- and post BCTTs and post cNP
testing. The phone follow-up inquired if the
subjects experienced any concussion
related symptoms affecting their athletics
or schooling after being deemed
asymptomatic.
Maturation: Concussions are very
subjective in their diagnosis and tracking
the heeling process requires either
tracking subjective symptoms or
comparing brain imaging. For this study
cNP testing was compared against BCTT
results to see if cNP results could predict
new or increased learning problems in the
classroom once the concussed athlete
was deemed asymptomatic.
Testing: The subjects received pre- and
post BCTTs and post cNP testing. The
phone follow-up inquired if the subjects
experienced any concussion related
symptoms affecting their athletics or
schooling after being deemed
asymptomatic.
Compensatory equalization of
treatment: Specific protocols were used.
A randomized prospective study with
blinding protocols would have increased
the validity of the study.
Compensatory rivalry: As this was a
retro selective chart review study with the
only contact after the patient was
discharged being a phone call follow-up
39
survey, and all subjects in the study
received the same follow-up survey, the
threat to internal validity was eliminated.
Statistical regression: There was only on
group in this study. The demographics
between the subjects were similar, which
eliminates the threat to internal validity.
Are the results of this therapeutic trial valid?
Appraisal Criterion
12. Did the investigators randomly assign subjects
to treatment groups?
a. If no, describe what was done
b. What are the potential consequences
of this assignment process for the
study’s results?
13. Did the investigators know who was being
assigned to which group prior to the
allocation?
a. If they were not blind, what are the
potential consequences of this
knowledge for the study’s results?
14. Were the groups similar at the start of the
trial? Did they report the demographics of the
study groups?
a. If they were not similar – what
differences existed?
b. Do you consider these differences a
threat to the research validity? How
might the differences between
groups affect the results of the
study?
15. Did the subjects know to which treatment
group they were assign?
a. If yes, what are the potential
consequences of the subjects’
knowledge for this study’s results
16. Did the investigators know to which
treatment group subjects were assigned ?
a. If yes, what are the potential
Reader’s Comments
No.
a. The study was based on a retrospective
chart review. Adolescent athletes
diagnosed with a concussion and referred
to a concussion clinic between 2010 and
2012 were eligible to be included in the
retrospective chart review and phone
survey follow-up study.
b. The results of the study could be made
more significant to the scientific community
if the study was a prospective study with a
control group, and if randomization and
blinding protocols were used.
a. All subjects were assigned to the same
group and received the same treatment.
No potential consequences exist.
The demographics of the participants were
disclosed and no significant discrepancies
existed.
There was only one group used for this
study eliminating any potential
consequences to the study’s results.
Yes, the investigators knew which group
the subjects were in. There was only one
group used for this study eliminating any
40
potential consequences to the study’s
results.
17. Were the groups managed equally, apart from All participants were managed equally.
consequences of the subjects’
knowledge for this study’s results
the actual experimental treatment?
a. If not, what are the potential
consequences of this knowledge for
the study’s results?
18. Was the subject follow-up time sufficiently
long to answer the question(s) posed by the
research?
a. If not, what are the potential
consequences of this knowledge for
the study’s results?
19. Did all the subjects originally enrolled
complete the study?
a. If not how many subjects were lost?
b. What, if anything, did the authors do
about this attrition?
c. What are the implications of the
attrition and the way it was handled
with respect to the study’s findings?
20. Were all patients analyzed in the groups to
which they were randomized (i.e. was there
an intention to treat analysis)?
a. If not, what did the authors do with
the data from these subjects?
b. If the data were excluded, what are
the potential consequences for this
study’s results?
Yes the subject follow-up time was
sufficient.
Yes all participants completed the study.
Yes all subjects’ data was analyzed.
Are the valid results of this RCT important?
Appraisal Criterion
Reader’s Comments
21. What were the statistical findings of this
a, c, d, e, f  N/A
study?
b. R programming language was used for
a. When appropriate use the
statistical analysis. Logistic regression
calculation forms below to determine
analysis was used to determine if results
these values
from cNP testing was predictive of learning
b. Include: tests of differences With pdifficulties. All subjects returned to sport a
values and CI
week after successfully completing the
c. Include effect size with p-values and
CI
BCTT and progressing through the
d. Include ARR/ABI and RRR/RBI with p- stepwise Zurich guidelines. About 39%
values and CI
reported new or increased problems in the
e. Include NNT and CI
classroom after being cleared to return.
f. Other stats should be included here
cNP testing was not proven to be
significant in predicting RTP success or
predicting new or increased learning
problems in the classroom.
22. What is the meaning of these statistical
The BCTT in combination with the Zurich
findings for your patient/client’s case? What
guidelines are reliable methods to in
does this mean to your practice?
determining RTP in concussed adolescent
41
23. Do these findings exceed a minimally
important difference? Was this brought up or
discussed?
a. If the MCID was not met, will you
still use this evidence?
athletes. The cNP testing did not prove
significant with predicting RTP or future
learning difficulties.
Minimally important difference was not
discussed in this study.
Can you apply this valid, important evidence about an intervention in
caring for your patient/client? What is the external validity?
Appraisal Criterion
24. Does this intervention sound appropriate for
use (available, affordable) in your clinical
setting? Do you have the facilities, skill set,
time, 3rd party coverage to provide this
treatment?
25. Are the study subjects similar to your patient/
client?
a. If not, how different? Can you use
this intervention in spite of the
differences?
26. Do the potential benefits outweigh the
potential risks using this intervention with
your patient/client?
Reader’s Comments
Yes the BCTT and Zurich guidleines are
available and affordable in all clinical
settings I have been exposed to as all
outpatient ortho PT clinics I have visited
have a treadmill, the Borg RPE is a
measurement tool taught in PT school,
and the exercises prescribed to patients
can be performed independently. As this
treadmill test is considered part of an
evaluation and the exercises prescribed
are considered therapeutic, 3rd party
payers will pay for the intervention.
However, the cNP testing is not available
to most clinics, but it was proven to not be
reliable or effective in testing individual for
readiness to return to play or school.
Yes, the study participants are similar to
the adolescent concussed patients I have
seen in practice.
As the treadmill test and exercises
prescribed are terminated immediately
upon exacerbation of concussion
symptoms there is little risk to the patient
in participating in this intervention.
27. Does the intervention fit within your
Yes, as my goal as a clinician is to help
patient/client’s stated values or expectations? return the patient to play/work asap, and
a. If not, what will you do now?
the patients goal is usually to RTP and
reduce symptoms ASAP as well.
28. Are there any threats to external validity in
All subjects in the study were adolescents.
this study?
The information contained in this study is
generalizable to the adolescent population
but not the greater general population.
42
What is the bottom line?
Appraisal Criterion
Reader’s Comments
PEDRO score (see scoring at end of form)
4
Summarize your findings and relate this back to clinical The BCTT in combination with the Zurich
significance
guidelines are reliable methods to in
determining RTP in concussed adolescent
athletes. The cNP testing did not prove
significant with predicting RTP or future
learning difficulties.
43
Name: David Scussel
Intervention – Evidence Appraisal Worksheet
Citation (use AMA or APA format):
Kozlowski, K., Graham, J., Leddy, J. J., Devinney-Boymel, L., & Willer, B. S.
(2013). Exercise intolerance in individuals with postconcussion syndrome.
Journal of Athletic Training, 48(5), 627-635.
Level of Evidence (Oxford scale):
1b, Individual inception cohort study with > 80% follow-up
Is the purpose and background information sufficient?
Appraisal Criterion
Study Purpose
Reader’s Comments
To assess exercise intolerance in patients
Stated clearly?
with postconcussion syndrome (PCS) as
Usually stated briefly in abstract and in greater seen by increases in concussion
symptoms during treadmill testing.
detail in introduction. May be phrased as a
question or hypothesis.
A clear statement helps you determine if topic
is important, relevant and of interest to you.
Consider how the study can be applied to PT
and/or your own situation. What is the
purpose of this study?
Yes, background information was
presented stating the graduated treadmill
Literature
test perfected by Dr. John Leddy, MD and
Relevant background presented?
his fellow researchers has proven to be
A review of the literature should provide
reliable and safe. This study’s intent is to
background for the study by synthesizing
elaborate on the measurements of heart
relevant information such as previous
rate, rate of perceived exertion (RPE)
research and gaps in current knowledge, along through the Borg Scale, systolic blood
with the clinical importance of the topic.
pressure [BP], and diastolic BP to show
Describe the justification of the need for this study
difference between health individuals and
individual with PCS during treadmill
testing.
Does the research design have strong internal validity?
Appraisal Criterion

Discuss possible threats to internal validity in
the research design. Include:
 Assignment
 Attrition
 History
Reader’s Comments
Assignment: 34 individuals diagnosed
with PCS who were consecutively referred
to a concussion clinic were placed in the
PCS group. 22 healthy individuals
matched to the PCS group’s
44






Instrumentation
Maturation
Testing
Compensatory Equalization of
treatments
Compensatory rivalry
Statistical Regression
demographics made up the control group.
No threat to internal validity.
Attrition: All subjects completed the
study.
History: The authors addressed the
history and progress of identifying
concussions and the history graduated
treadmill testing PCS patients.
Instrumentation: The treadmill test
followed the Balke protocol to the first sign
of concussive symptom exacerbation. “The
treadmill speed was set at 3.3 miles per
hour at a 0.0% incline… After 1 minute, we
increased the treadmill grade to 2.0% and
instructed the participant to maintain the
same walking speed... At each 2-minute
interval, BP was taken. At the start of the
third minute and each minute thereafter,
we increased the grade by 1.0%,
measured heart rate and RPE, and
assessed the presence of symptoms.” All
participants received the same treatment
decreasing the threat to internal validity.
Maturation: Concussions are very
subjective in their diagnosis to begin with
and tracking the heeling process requires
tracking subjective symptoms reported by
the patient.
Testing: All subjects participated in the
treadmill test following the Balke protocol.
The test was ended for any individual if
they became too fatigued to continue, if
any subject in the PCS group began to
experience any exacerbation in
concussion symptoms, or if the individual
reached the end of the test at 21 minutes.
Compensatory equalization of
treatment: Specific protocols were used.
A randomized study with blinding protocols
would have increased the validity of the
study.
Compensatory rivalry: All subjects
participated in the treadmill training
protocol eliminating compensating rivalry.
Statistical regression: Those who had
experienced concussions were put into the
45
PCS group while those who had never
experienced a concussion were put into
the control group. The PCS group was not
split into subsequent groups. The control
group was comprised of individuals
matching the demographics of the PCS
group members.
Are the results of this therapeutic trial valid?
Appraisal Criterion
29. Did the investigators randomly assign subjects
to treatment groups?
a. If no, describe what was done
b. What are the potential consequences
of this assignment process for the
study’s results?
30. Did the investigators know who was being
assigned to which group prior to the
allocation?
a. If they were not blind, what are the
potential consequences of this
knowledge for the study’s results?
31. Were the groups similar at the start of the
trial? Did they report the demographics of the
study groups?
a. If they were not similar – what
differences existed?
b. Do you consider these differences a
threat to the research validity? How
might the differences between
groups affect the results of the
study?
32. Did the subjects know to which treatment
group they were assign?
a. If yes, what are the potential
consequences of the subjects’
knowledge for this study’s results
Reader’s Comments
No.
a. 34 individuals diagnosed with PCS who
were consecutively referred to a
concussion clinic were placed in the PCS
group. 22 healthy individuals matched to
the PCS group’s demographics were
placed in the control group.
b. The results of the study could be made
more significant to the scientific community
if the study blinding protocols were used.
a. The researchers were not blinded to
whether the participants were members of
the PCS group or the control group. The
potential consequence of ending the test
too soon existed of the PCS group as the
researchers could have been too hypervigilant about looking for exacerbation of
concussion symptoms. If the researchers
were blinded to the participants’ group
assignment this potential consequence
could have been eliminated.
The groups were similar in demographics
at the beginning of the study and no
significant differences existed between the
two groups concerning demographics.
All subjects completed the same test,
eliminating any potential consequences to
the study’s results.
46
33. Did the investigators know to which
treatment group subjects were assigned ?
a. If yes, what are the potential
consequences of the subjects’
knowledge for this study’s results
Yes, the investigators knew which group
the subjects were in. The potential
consequence of ending the test too soon
existed of the PCS group as the
researchers could have been too hypervigilant about looking for exacerbation of
concussion symptoms. If the researchers
were blinded to the participants’ group
assignment this potential consequence
could have been eliminated.
34. Were the groups managed equally, apart from All participants were managed equally.
the actual experimental treatment?
a. If not, what are the potential
consequences of this knowledge for
the study’s results?
35. Was the subject follow-up time sufficiently
long to answer the question(s) posed by the
research?
a. If not, what are the potential
consequences of this knowledge for
the study’s results?
36. Did all the subjects originally enrolled
complete the study?
a. If not how many subjects were lost?
b. What, if anything, did the authors do
about this attrition?
c. What are the implications of the
attrition and the way it was handled
with respect to the study’s findings?
37. Were all patients analyzed in the groups to
which they were randomized (i.e. was there
an intention to treat analysis)?
a. If not, what did the authors do with
the data from these subjects?
b. If the data were excluded, what are
the potential consequences for this
study’s results?
There was no follow-up.
Yes all participants completed the study.
a. After completion of the treadmill test 1
PCS group subject’s data was removed
statistical analysis due to the values being
highly variable and greater than 2 times
the standard deviation.
b. As only 1 of 34 group members’ data
was removed form the study, the study’s
data remains viable and no potential
consequences exist. If that group
member’s data was left in the study their
data would potentially skew the data of the
PCS group.
Are the valid results of this RCT important?
Appraisal Criterion
38. What were the statistical findings of this
study?
a. When appropriate use the
calculation forms below to determine
these values
b. Include: tests of differences With p-
Reader’s Comments
a, c, d, e, f  N/A
b. Independent t-tests to assess
differences in group means. Cohen d was
used for effect size of test duration, max
heart rate, RPE, max systolic BP, and max
47
values and CI
Include effect size with p-values and
CI
d. Include ARR/ABI and RRR/RBI with pvalues and CI
e. Include NNT and CI
f. Other stats should be included here
c.
39. What is the meaning of these statistical
findings for your patient/client’s case? What
does this mean to your practice?
40. Do these findings exceed a minimally
important difference? Was this brought up or
discussed?
a. If the MCID was not met, will you
still use this evidence?
diastolic BP. Effect size > 0.80 was
considered high; 0.050 to 0.80 was
considered moderate to high; and ≤ 0.050
was considered low.
Test duration mean: PCS 8.5 min,
control17.9 min (P<0.001).
Max heart rate mean: PCS 142.8, control
175.2 (P<0.001).
Max systolic BP: PCS 142.1, control 155.5
(P=0.02)
Max diastolic BP: PCS 79.7, control 73.5
(P=0.03)
“The Cohen d effect size criteria for clinical
differences demonstrated a high effect
size (.0.80) for test duration (2.3), maximal
heart rate (1.5), and RPE (1.6) and a
moderate to high effect size (.0.50) for
maximal systolic BP (0.61) and diastolic
BP (0.58).”
The PCS group subjects had significantly
decreased tolerance to the treadmill test
than their healthy counterparts. Exercise
prescriptions should be individualized for
patients with PCS based on results from a
graduated treadmill test.
Minimally important difference was not
discussed in this study.
Can you apply this valid, important evidence about an intervention in
caring for your patient/client? What is the external validity?
Appraisal Criterion
41. Does this intervention sound appropriate for
use (available, affordable) in your clinical
setting? Do you have the facilities, skill set,
time, 3rd party coverage to provide this
treatment?
42. Are the study subjects similar to your patient/
client?
a. If not, how different? Can you use
this intervention in spite of the
differences?
Reader’s Comments
Yes the intervention is both available and
affordable in all clinical settings I have
been exposed to as all outpatient ortho PT
clinics I have visited have a treadmill, and
the Borg RPE is a measurement tool
taught in PT school. As this intervention is
considered part of an evaluation 3rd party
payers will pay for it.
Yes, the study participants are similar to
the concussed patients I have seen in
practice.
48
43. Do the potential benefits outweigh the
potential risks using this intervention with
your patient/client?
As the treadmill test is ended immediately
upon exacerbation of concussion
symptoms or patient reported fatigue there
is little risk to the patient in participating in
this intervention.
44. Does the intervention fit within your
Yes, as my goal as a clinician is to help
patient/client’s stated values or expectations? return the patient to play/work asap, and
a. If not, what will you do now?
the patients goal is usually to RTP and
reduce symptoms ASAP as well.
45. Are there any threats to external validity in
The sample size of the study for the
this study?
control group was low, n=22. This is a
threat to external validity.
What is the bottom line?
Appraisal Criterion
PEDRO score (see scoring at end of form)
Summarize your findings and relate this back to clinical
significance
Reader’s Comments
5
From the systemic evidence quantified
form this study, patients with PCS maybe
able to safely participate in exercises at a
low-levels (<75% age predicted max heart
rate). However, the exercise prescription
should be individualized based on results
from a graduated treadmill test.
49
Name: David Scussel
Intervention – Evidence Appraisal Worksheet
Citation (use AMA or APA format):
Leddy, J. J., Baker, J. G., Kozlowski, K., Bisson, L., & Willer, B. (2011). Reliability
of a graded exercise test for assessing recovery from concussion. Clinical
Journal of Sport Medicine, 21(2), 89-94.
Level of Evidence (Oxford scale):
1b, Individual inception cohort study with > 80% follow-up
Is the purpose and background information sufficient?
Appraisal Criterion
Study Purpose
Reader’s Comments
Yes, the purpose of the study was to
Stated clearly?
assess the retest reliability (RTR) and
Usually stated briefly in abstract and in greater interrater reliability (IRR) of a standardized
graded treadmill exercise test in
detail in introduction. May be phrased as a
determining return to play (RTP) status of
question or hypothesis.
A clear statement helps you determine if topic both concussed athletes and nonathletes.
is important, relevant and of interest to you.
Consider how the study can be applied to PT
and/or your own situation. What is the
purpose of this study?
Literature
Relevant background presented?
A review of the literature should provide
background for the study by synthesizing
relevant information such as previous
research and gaps in current knowledge, along
with the clinical importance of the topic.
Describe the justification of the need for this study
Yes, background information was
presented making the case the stepwise
program for recovery from concussions
starting with rest and ending with full
contact practice while progressing through
each stage every 24 hours may be
outdated and is not a proven reliable
method. Further background was
presented to indicate provocative
exercising testing of concussed individuals
maybe proven to be a reliable method with
replicable studies.
Does the research design have strong internal validity?
Appraisal Criterion

Discuss possible threats to internal validity in
the research design. Include:
 Assignment
 Attrition
 History
Reader’s Comments
Assignment: Twenty-one subjects
(11athletes and 10 non-athletes)
experiencing concussion symptoms ≥6
weeks but <52 weeks referred
50






Instrumentation
Maturation
Testing
Compensatory Equalization of
treatments
Compensatory rivalry
Statistical Regression
consecutively to a concussion clinic, and
10 control subjects (no history of
concussions and sedentary for the past 6
weeks) were assigned to the study. The
study would have had a narrow confidence
interval if a greater number of participants
were recruited for both the experimental
and control groups.
Attrition: All participants completed the
study.
History: The authors addressed the
history and lack of reliability of the
stepwise progression methods used to
clear individuals for return to play after
being concussed.
Instrumentation: The treadmill test
followed the Balke protocol to the first sign
of concussive symptom exacerbation. “The
treadmill speed was set at 3.3 mph at
0.0% incline. After 1 minute, the grade
increased to 2.0% while maintaining the
same speed. At the start of the third
minute and each minute thereafter, the
grade increased by 1.0%, maintaining the
speed at 3.3 mph.” RPE and heart rate
were recorded every minute with BP being
recorded every 2 minutes.
Maturation: Concussions are very
subjective in their diagnosis to begin with
and tracking the heeling process requires
tracking subjective symptoms reported by
the patient.
Testing: The test was performed on all
subjects 2 to 3 weeks apart. I would
assume testing at least once or twice more
would have validated the results further.
Although, increasing the length of the
study would have probably resulted in an
increase in attrition.
Compensatory equalization of
treatment: Specific protocols were used.
Blinding of patients and researchers would
have increased the validity of the study.
Compensatory rivalry: All subjects
participated in the treadmill training
protocol eliminating compensating rivalry.
51
Statistical regression: Those who had
experienced concussions were put into the
PCS group while those who had never
experienced a concussion were put into
the control group. The PCS group was not
split into subsequent groups.
Are the results of this therapeutic trial valid?
Appraisal Criterion
Reader’s Comments
46. Did the investigators randomly assign subjects No.
to treatment groups?
a. 21 consecutive concussion patients with
a. If no, describe what was done
symptoms ≥6 weeks but <52 weeks
b. What are the potential consequences
referred to a concussion clinic were placed
of this assignment process for the
in the PCS group. 10 control subjects with
study’s results?
no history of concussions and having been
sedentary for the past 6 weeks were
placed in the control group.
b. No potential consequences exist as all
subjects participated in the treadmill
protocol and gave their consent to
participate in the study.
47. Did the investigators know who was being
a. The researchers were not blinded to
assigned to which group prior to the
whether the participants were members of
allocation?
the PCS group or the control group. No
a. If they were not blind, what are the
potential consequences existed as all
potential consequences of this
subjects completed the study’s protocol.
knowledge for the study’s results?
48. Were the groups similar at the start of the
The groups were similar in demographics
trial? Did they report the demographics of the at the beginning of the study and no
study groups?
significant differences existed between the
a. If they were not similar – what
two groups concerning demographics.
differences existed?
b. Do you consider these differences a
threat to the research validity? How
might the differences between
groups affect the results of the
study?
49. Did the subjects know to which treatment
group they were assign?
a. If yes, what are the potential
consequences of the subjects’
knowledge for this study’s results
50. Did the investigators know to which
treatment group subjects were assigned ?
a. If yes, what are the potential
consequences of the subjects’
knowledge for this study’s results
51. Were the groups managed equally, apart from
Yes, all subjects knew which group they
were in. As all participants completed the
treadmill protocol no potential
consequences existed.
Yes, the investigators knew which group
the subjects were in. As all participants
completed the treadmill protocol no
potential consequences existed.
All participants completed the treadmill
52
the actual experimental treatment?
a. If not, what are the potential
consequences of this knowledge for
the study’s results?
52. Was the subject follow-up time sufficiently
long to answer the question(s) posed by the
research?
a. If not, what are the potential
consequences of this knowledge for
the study’s results?
53. Did all the subjects originally enrolled
complete the study?
a. If not how many subjects were lost?
b. What, if anything, did the authors do
about this attrition?
c. What are the implications of the
attrition and the way it was handled
with respect to the study’s findings?
54. Were all patients analyzed in the groups to
which they were randomized (i.e. was there
an intention to treat analysis)?
a. If not, what did the authors do with
the data from these subjects?
b. If the data were excluded, what are
the potential consequences for this
study’s results?
protocol and were managed equally.
Yes the subject follow-up time was
sufficient. If the follow-up time were
lengthened it would have increased the
validity of the results of the study but also
increased the attrition of participants.
Yes all participants completed the study.
Yes all subjects’ data was analyzed in the
groups to which they were assigned.
Are the valid results of this RCT important?
Appraisal Criterion
Reader’s Comments
55. What were the statistical findings of this
a, c, d, e, f  N/A
study?
b. Cohen’s criteria for effect size for
a. When appropriate use the
intraclass correlation coefficient (ICC)
calculation forms below to determine
(SPSS version 16.0; SPSS, Inc., Chicago,
these values
Illinois) was used to report agreement of
b. Include: tests of differences With pmaximal heart rate, SBP, DBP, and RPE
values and CI
between the 2 treadmill tests.
c. Include effect size with p-values and
CI
95% CI was used.
d. Include ARR/ABI and RRR/RBI with p- P was reported, but not set to a
values and CI
significance level such as P < 0.05.
e. Include NNT and CI
PCS group ICC and P stats: heart rate ICC
f. Other stats should be included here
0.79 P<0.36, max SBP ICC 0.37 P<0.02,
DBP ICC 0.20 P<0.80, RPE ICC 0.42
P<0.09.
Control group ICC and P stats: heart rate
ICC 0.64 P<0.97, max SBP ICC 0.90
P<0.71, DBP ICC 0.52 P<0.37, RPE ICC
0.80 P<0.11.
56. What is the meaning of these statistical
RTR for the treadmill test revealed
findings for your patient/client’s case? What
maximal heart rate to have good RTR and
does this mean to your practice?
moderate RTR for maximal SBP. DBP
53
57. Do these findings exceed a minimally
important difference? Was this brought up or
discussed?
a. If the MCID was not met, will you
still use this evidence?
proved to not be a reliable reproducible
measurement. The treadmill test is a
reliable method test to use in the clinic for
those who have been concussed.
Minimally important difference was not
discussed in this study.
Can you apply this valid, important evidence about an intervention in
caring for your patient/client? What is the external validity?
Appraisal Criterion
58. Does this intervention sound appropriate for
use (available, affordable) in your clinical
setting? Do you have the facilities, skill set,
time, 3rd party coverage to provide this
treatment?
59. Are the study subjects similar to your patient/
client?
a. If not, how different? Can you use
this intervention in spite of the
differences?
60. Do the potential benefits outweigh the
potential risks using this intervention with
your patient/client?
Reader’s Comments
Yes the intervention is both available and
affordable in all clinical settings I have
been exposed to as all outpatient ortho PT
clinics I have visited have a treadmill, and
the Borg RPE is a measurement tool
taught in PT school. As this intervention is
considered part of an evaluation 3rd party
payers will pay for it.
Yes, the study participants are similar to
the concussed patients I have seen in
practice.
As the treadmill test is terminated
immediately upon exacerbation of
concussion symptoms or if the patient
fatigues out, while heart rate and BP are
being monitored frequently, there is little
risk to the patient in participating in this
intervention.
61. Does the intervention fit within your
Yes, as my goal as a clinician is to help
patient/client’s stated values or expectations? return the patient to play/work asap, and
a. If not, what will you do now?
the patients goal is usually to RTP and
reduce symptoms ASAP as well.
62. Are there any threats to external validity in
The sample size of the study for both the
this study?
experimental and control groups were low,
21 and 10 respectively. This is a threat to
external validity.
What is the bottom line?
Appraisal Criterion
PEDRO score (see scoring at end of form)
Reader’s Comments
5
54
Summarize your findings and relate this back to clinical
significance
The Balke exercise treadmill test for
symptom identification in concussed
patients has “sufficient maximum heart
rate RTR,” and appears to be a more
reliable method for tracking the progress of
athletes trying to RTP than the stepwise
program, which is subjective. Further
studies need to be performed.
55
Name: David Scussel
Intervention – Evidence Appraisal Worksheet
Citation (use AMA or APA format):
Leddy, J. J., Cox, J. L., Baker, J. G., Wack, D. S., Pendergast, D. R., Zivadinov,
R., & Willer, B. (2013). Exercise treatment for postconcussion syndrome: A
pilot study of changes in functional magnetic resonance imaging activation,
physiology, and symptoms. The Journal of Head Trauma Rehabilitation,
28(4), 241-249.
Level of Evidence (Oxford scale):
1b, Individual RTC
Is the purpose and background information sufficient?
Appraisal Criterion
Study Purpose
Reader’s Comments
To compare before and after fMRI results
Stated clearly?
between subjects with postconcussion
Usually stated briefly in abstract and in greater syndrome (PCS) who received an exercise
program, subjects with PCS who received
detail in introduction. May be phrased as a
a placebo intervention, and a healthy
question or hypothesis.
A clear statement helps you determine if topic control group.
is important, relevant and of interest to you.
Consider how the study can be applied to PT
and/or your own situation. What is the
purpose of this study?
Literature
Relevant background presented?
A review of the literature should provide
background for the study by synthesizing
relevant information such as previous
research and gaps in current knowledge, along
with the clinical importance of the topic.
Yes, background information was
presented stating fMRI has been used with
subjects diagnosed with PCS when
completing cognitive tasks but has yet to
be utilized to show results from before and
after treatment techniques meant to help
resolve PCS symptoms.
Describe the justification of the need for this study
Does the research design have strong internal validity?
Appraisal Criterion

Discuss possible threats to internal validity in
the research design. Include:
 Assignment
 Attrition
 History
Reader’s Comments
Assignment: The first 4 PCS patients
eligible for treatment were assigned to the
exercise PCS groups, the next 4 PCS
patients were assigned to the placebo
stretching group. The assignment process
was chosen in order to keep interaction
56






Instrumentation
Maturation
Testing
Compensatory Equalization of
treatments
Compensatory rivalry
Statistical Regression
between the patients separate and to help
them to think they were receiving the best
available treatment to them. The
assignment process decreased the risk to
internal validity.
Attrition: All participants completed the
study.
History: The authors addressed the
history of fMRI used in the PCS population
and the need for this study.
Instrumentation: The PCS exercise
group performed a progressive aerobic
exercise program at 80% of the heart rate
subthreshold to exacerbation of
concussion symptoms found through
treadmill testing. The aerobic exercise
program was 20 minutes/day, 6days/week,
in the home or at a gym. The PCS placebo
group received a sham stretching program
(stretched 20 minutes/day 6 days/week)
and were instructed not to exceed 40%50% of their age predicted max heart rate.
The control group was comprised of
healthy subjects who were matched to the
demographics of the PCS subjects. fMRI
results were compared between the 3
groups before treatment began and 12
weeks later.
Maturation: Concussions are very
subjective in their diagnosis and tracking
the heeling process requires either
tracking subjective symptoms or
comparing brain imaging. For this study
fMRI results were compared between the
3 groups before treatment began and 12
weeks later.
Testing: The group performed their
respective treatments for 12 weeks. fMRI
results were compared between the 3
groups before treatment began and 12
weeks later.
Compensatory equalization of
treatment: Specific protocols were used.
Blinding of patients and researchers would
have increased the validity of the study.
Compensatory rivalry: The PCS subjects
57
were assigned to their respective groups in
succession as described in the assignment
section in order to prevent interaction and
help the subjects to think they were
receiving the best available treatment.
Statistical regression: Demographics
between the groups were similar and the
control group was matched to the PCS
groups to help eliminate the threat to
internal validity.
Are the results of this therapeutic trial valid?
Appraisal Criterion
Reader’s Comments
63. Did the investigators randomly assign subjects No.
to treatment groups?
a. The first 4 PCS patients eligible for
a. If no, describe what was done
treatment were assigned to the exercise
b. What are the potential consequences
PCS groups, the next 4 PCS patients were
of this assignment process for the
assigned to the placebo stretching group.
study’s results?
The assignment process was chosen in
order to keep interaction between the
patients separate and to help them to think
they were receiving the best available
treatment to them.
b. Without randomization the potential to
have discrepancies between groups could
result in skewed results.
64. Did the investigators know who was being
a. The researchers did not know which
assigned to which group prior to the
subjects would be placed into which group
allocation?
before hand as the subject had not yet
a. If they were not blind, what are the
been patients at the clinic were the
potential consequences of this
experiment was being held. The
knowledge for the study’s results?
assignment to the two PCS groups was
based on who was referred to the clinic
first. The first 4 PCS subjects referred to
the clinic were assigned to the exercise
group. The next 4 referred were assigned
to the placebo group.
65. Were the groups similar at the start of the
The demographics of the participants were
trial? Did they report the demographics of the disclosed and no significant discrepancies
study groups?
existed. The control, healthy subjects were
a. If they were not similar – what
matched to the PCS subjects.
differences existed?
b. Do you consider these differences a
threat to the research validity? How
might the differences between
groups affect the results of the
58
study?
66. Did the subjects know to which treatment
group they were assign?
a. If yes, what are the potential
consequences of the subjects’
knowledge for this study’s results
No. The PCS subjects were kept apart
from each other and did not know what
type of treatment the other groups were
receiving. However the control group knew
they were the healthy control group only
receiving fMRIs twice over a 12 week
period.
67. Did the investigators know to which
Yes, the investigators knew which group
treatment group subjects were assigned ?
the subjects were in. As the study’s results
a. If yes, what are the potential
depended on imaging results, which are
consequences of the subjects’
objective, results and free of bias, potential
knowledge for this study’s results
consequences were eliminated.
68. Were the groups managed equally, apart from All participants were managed equally.
the actual experimental treatment?
a. If not, what are the potential
consequences of this knowledge for
the study’s results?
69. Was the subject follow-up time sufficiently
long to answer the question(s) posed by the
research?
a. If not, what are the potential
consequences of this knowledge for
the study’s results?
70. Did all the subjects originally enrolled
complete the study?
a. If not how many subjects were lost?
b. What, if anything, did the authors do
about this attrition?
c. What are the implications of the
attrition and the way it was handled
with respect to the study’s findings?
71. Were all patients analyzed in the groups to
which they were randomized (i.e. was there
an intention to treat analysis)?
a. If not, what did the authors do with
the data from these subjects?
b. If the data were excluded, what are
the potential consequences for this
study’s results?
Yes the subject follow-up time was
sufficient to show significant changes in
results from before treatment
implementation and after.
Yes all participants completed the study.
Yes all subjects’ data was analyzed.
Are the valid results of this RCT important?
Appraisal Criterion
Reader’s Comments
72. What were the statistical findings of this
a, c, d, e, f  N/A
study?
b. fMRI results before treatment: No
a. When appropriate use the
difference between the exercise and
calculation forms below to determine
placebo PCS groups, the control group
these values
had greater activation in the posterior
b. Include: tests of differences With pcingulate gyrus, lingual gyrus, and
values and CI
cerebellum (P<0.05). fMRI results after
c. Include effect size with p-values and
59
CI
d. Include ARR/ABI and RRR/RBI with pvalues and CI
e. Include NNT and CI
f. Other stats should be included here
73. What is the meaning of these statistical
findings for your patient/client’s case? What
does this mean to your practice?
74. Do these findings exceed a minimally
important difference? Was this brought up or
discussed?
a. If the MCID was not met, will you
still use this evidence?
treatment: No differences between the
exercise PCS group and the control group,
the placebo PCS group had significantly
(P<0.05) less cerebellar activity.
A prescribed progressive aerobic exercise
program, as used in this study, appears
beneficial in the recovery from PCS and to
help restore cerebral blood flow regulation.
The concussed population I have seen in
clinic thus far has benefitted from such
intervention techniques, and should
continue to benefit from it.
Minimally important difference was not
discussed in this study.
Can you apply this valid, important evidence about an intervention in
caring for your patient/client? What is the external validity?
Appraisal Criterion
75. Does this intervention sound appropriate for
use (available, affordable) in your clinical
setting? Do you have the facilities, skill set,
time, 3rd party coverage to provide this
treatment?
76. Are the study subjects similar to your patient/
client?
a. If not, how different? Can you use
this intervention in spite of the
differences?
77. Do the potential benefits outweigh the
potential risks using this intervention with
your patient/client?
Reader’s Comments
Yes the intervention is both available and
affordable in all clinical settings I have
been exposed to as all outpatient ortho PT
clinics I have visited have a treadmill, the
Borg RPE is a measurement tool taught in
PT school, and the exercises prescribed to
patients can be performed independently.
As this treadmill test is considered part of
an evaluation and the exercises prescribed
are considered therapeutic, 3rd party
payers will pay for the intervention.
Yes, the study participants are similar to
the concussed patients I have seen in
practice.
As the treadmill test and exercises
prescribed are terminated immediately
upon exacerbation of concussion
symptoms there is little risk to the patient
in participating in this intervention.
78. Does the intervention fit within your
Yes, as my goal as a clinician is to help
patient/client’s stated values or expectations? return the patient to play/work asap, and
a. If not, what will you do now?
the patients goal is usually to RTP and
reduce symptoms ASAP as well.
60
79. Are there any threats to external validity in
this study?
The sample size of the study was low (for
each group n=4). This is a threat to
external validity as there is great potential
the population studied does not generalize
to the great general population.
What is the bottom line?
Appraisal Criterion
PEDRO score (see scoring at end of form)
Summarize your findings and relate this back to clinical
significance
Reader’s Comments
7
A prescribed progressive aerobic exercise
program at 80% of the heart rate
subthreshold to exacerbation of
concussion symptoms found through
treadmill testing performed 20min/day
most days of the week appears beneficial
in the recovery from PCS and appears to
help restore cerebral blood flow regulation.
61
Name: David Scussel
Intervention – Evidence Appraisal Worksheet
Citation (use AMA or APA format):
Leddy, J. J., Kozlowski, K., Donnelly, J. P., Pendergast, D. R., Epstein, L. H., &
Willer, B. (2010). A preliminary study of subsymptom threshold exercise
training for refractory post-concussion syndrome. Clinical Journal of Sport
Medicine, 20(1), 21-27.
Level of Evidence (Oxford scale):
1b, Individual inception cohort study with > 80% follow-up
Is the purpose and background information sufficient?
Appraisal Criterion
Study Purpose
Reader’s Comments
To show the safety and effectiveness of
Stated clearly?
reducing concussive symptoms in
Usually stated briefly in abstract and in greater individuals with post concussion syndrome
(PCS) through the implementation a
detail in introduction. May be phrased as a
progressive subsymptom threshold
question or hypothesis.
A clear statement helps you determine if topic exercise training (SSTET) program.
is important, relevant and of interest to you.
Consider how the study can be applied to PT
and/or your own situation. What is the
purpose of this study?
Literature
Relevant background presented?
A review of the literature should provide
background for the study by synthesizing
relevant information such as previous
research and gaps in current knowledge, along
with the clinical importance of the topic.
Describe the justification of the need for this study
Yes, background information was
presented making the case autonomic
function is altered and cerebral
autoregulation is impaired after being
concussed and through SSTET the
parasympathetic system activity will
increase, the sympathetic activity will
decrease and cerebral blood flow will
improve thereby improving the symptoms
experienced by the concussed population.
Does the research design have strong internal validity?
Appraisal Criterion

Discuss possible threats to internal validity in
the research design. Include:
 Assignment
 Attrition
 History
Reader’s Comments
Assignment: Twelve subjects
experiencing PCS symptoms ≥6 weeks but
<52 weeks referred consecutively to a
concussion clinic participated in the study.
The low number of participants could
62






Instrumentation
Maturation
Testing
Compensatory Equalization of
treatments
Compensatory rivalry
Statistical Regression
potentially affect the validity of the study,
as the subject pool may not accurately
represent the general population.
Attrition: All participants completed the
study.
History: The authors addressed the
history and lack of interventions to assist
individuals who do not recover
spontaneously after being concussed.
Instrumentation: The treadmill test
followed the Balke protocol to the first sign
of concussive symptom exacerbation. “The
treadmill speed was set at 3.3 mph at
0.0% incline. After 1 minute, the grade was
increased to 2.0% while maintaining the
same speed. At the start of the third
minute and each minute thereafter, the
grade was increased by 1.0%, maintaining
speed at 3.3 mph.” RPE and heart rate
were recorded every minute with BP being
recorded every 2 minutes.
Maturation: Concussions are very
subjective in their diagnosis to begin with
and tracking the heeling process requires
tracking subjective symptoms reported by
the patient. In order to track the
progression of the subjective symptoms
the authors had the subjects record their
symptoms using the Graded Symptom
Checklist (GSC) everyday at the same
time before exercising.
Testing: The treadmill test was performed
on all subjects 2 to 3 weeks apart, then
once every 3 weeks until symptoms
resolved for the individual subjects. Three
months after symptoms resolved the
subjects were followed up with a phone
survey to see if they returned to full
functioning.
Compensatory equalization of
treatment: Specific protocols were used.
Blinding of patients and researchers would
have increased the validity of the study.
Compensatory rivalry: All subjects
participated in all elements of the study
eliminating compensating rivalry.
63
Statistical regression: The age range
(16-53) and length of time post-concussion
at time of induction into the study (6-40
weeks) was broad. Due to the small
sample size (12) these broad ranges can
be a threat to internal validity.
Are the results of this therapeutic trial valid?
Appraisal Criterion
Reader’s Comments
80. Did the investigators randomly assign subjects No.
to treatment groups?
a. 12 consecutive concussion patients with
a. If no, describe what was done
symptoms ≥6 weeks but <52 weeks
b. What are the potential consequences
referred to a concussion clinic were
of this assignment process for the
included in the study.
study’s results?
b. Without a concussed control group and
random assignment into the two potential
groups the results of the study become
muted as it leaves the community
reviewing this study asking if the results
were due to chance or due to the
intervention.
81. Did the investigators know who was being
a. There was only one group for this study.
assigned to which group prior to the
The researchers were aware that all
allocation?
subjects were receiving the treatment. It
a. If they were not blind, what are the
would be evident to the trained clinician
potential consequences of this
who was in the control group, if one were
knowledge for the study’s results?
used for this study, receiving a shame
treadmill test and exercise program, or no
exercise. Therefore blinding the clinicians
would not be pertinent in this study.
82. Were the groups similar at the start of the
a. The demographics of the subjects
trial? Did they report the demographics of the varied greatly: The age range (16-53) and
study groups?
length of time post-concussion at time of
a. If they were not similar – what
induction into the study (6-40 weeks) was
differences existed?
broad.
b. Do you consider these differences a
b. Due to the small sample size (12) these
threat to the research validity? How
broad ranges can be a threat to internal
might the differences between
groups affect the results of the
validity.
study?
83. Did the subjects know to which treatment
group they were assign?
a. If yes, what are the potential
consequences of the subjects’
knowledge for this study’s results
84. Did the investigators know to which
treatment group subjects were assigned ?
Yes, all subjects knew which group they
were in. As all participants completed the
treadmill protocol and SSTET. No potential
consequences existed.
Yes, the investigators knew which group
64
a.
If yes, what are the potential
consequences of the subjects’
knowledge for this study’s results
the subjects were in. As all participants
completed the treadmill protocol and
SSTET. No potential consequences
existed.
85. Were the groups managed equally, apart from All participants completed the treadmill
the actual experimental treatment?
protocol and SSTET, and were managed
a. If not, what are the potential
equally.
consequences of this knowledge for
the study’s results?
86. Was the subject follow-up time sufficiently
long to answer the question(s) posed by the
research?
a. If not, what are the potential
consequences of this knowledge for
the study’s results?
87. Did all the subjects originally enrolled
complete the study?
a. If not how many subjects were lost?
b. What, if anything, did the authors do
about this attrition?
c. What are the implications of the
attrition and the way it was handled
with respect to the study’s findings?
88. Were all patients analyzed in the groups to
which they were randomized (i.e. was there
an intention to treat analysis)?
a. If not, what did the authors do with
the data from these subjects?
b. If the data were excluded, what are
the potential consequences for this
study’s results?
Yes the subject follow-up time was
sufficient. All participants at the end of the
follow-up time reported resolution of all
concussion symptoms.
Yes all participants completed the study.
Yes all subjects’ data was analyzed. Only
one group existed for this study.
Are the valid results of this RCT important?
Appraisal Criterion
Reader’s Comments
89. What were the statistical findings of this
a, c, d, e, f  N/A
study?
b. All 12 subjects were able to follow the
a. When appropriate use the
exercise prescription with no adverse
calculation forms below to determine
reactions. Significant differences with
these values
paired t-test: Baseline and end treatment
b. Include: tests of differences With pGSC (P=0.002), exercise duration
values and CI
increased significantly (P=0.001), and
c. Include effect size with p-values and
CI
peak heart rate and SBP with exercise
d. Include ARR/ABI and RRR/RBI with p- increase significantly (both P<0.001). The
values and CI
phone follow-up revealed all subjects
e. Include NNT and CI
completely returned to work, school, and
f. Other stats should be included here
athletic activities.
90. What is the meaning of these statistical
findings for your patient/client’s case? What
does this mean to your practice?
Individualized progressive SSTET appears
to be safe and assists in the recovery of
PCS. The concussed population I have
65
91. Do these findings exceed a minimally
important difference? Was this brought up or
discussed?
a. If the MCID was not met, will you
still use this evidence?
seen in clinic thus far has benefitted from
such intervention techniques.
Minimally important difference was not
discussed in this study.
Can you apply this valid, important evidence about an intervention in
caring for your patient/client? What is the external validity?
Appraisal Criterion
92. Does this intervention sound appropriate for
use (available, affordable) in your clinical
setting? Do you have the facilities, skill set,
time, 3rd party coverage to provide this
treatment?
93. Are the study subjects similar to your patient/
client?
a. If not, how different? Can you use
this intervention in spite of the
differences?
94. Do the potential benefits outweigh the
potential risks using this intervention with
your patient/client?
Reader’s Comments
Yes the intervention is both available and
affordable in all clinical settings I have
been exposed to as all outpatient ortho PT
clinics I have visited have a treadmill, the
Borg RPE is a measurement tool taught in
PT school, and the exercises prescribed to
patients can be performed independently.
As this treadmill test is considered part of
an evaluation and the exercises prescribed
are considered therapeutic 3rd party payers
will pay for the intervention.
Yes, the study participants are similar to
the concussed patients I have seen in
practice.
As the treadmill test and exercises
prescribed are terminated immediately
upon exacerbation of concussion
symptoms there is little risk to the patient
in participating in this intervention.
95. Does the intervention fit within your
Yes, as my goal as a clinician is to help
patient/client’s stated values or expectations? return the patient to play/work asap, and
a. If not, what will you do now?
the patients goal is usually to RTP and
reduce symptoms ASAP as well.
96. Are there any threats to external validity in
The sample size of the study was low
this study?
(n=12). This is a threat to external validity.
What is the bottom line?
Appraisal Criterion
Reader’s Comments
PEDRO score (see scoring at end of form)
4
Summarize your findings and relate this back to clinical Individualized progressive SSTET appears
significance
to be safe and assists in the recovery of
PCS. The Balke exercise treadmill test
66
should be used to establish an
individualized exercise duration and
intensity, and be used throughout the
treatment phase in order to monitor the
patient’s symptoms and tolerance of
exercise.
67
Name: David Scussel
Systematic Review – Evidence Appraisal Worksheet
Citation (use AMA or APA format):
Leddy, J. J., Sandhu, H., Sodhi, V., Baker, J. G., & Willer, B. (2012).
Rehabilitation of concussion and post-concussion syndrome. Sports Health: A
Multidisciplinary Approach, 4(2), 147-154.
Level of Evidence (Oxford scale): 2a, Systematic Review of cohort studies,
retrospective cohort studies, and Level 2b and better studies
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 define the focus of
the review: To review available literature
on recommendations for rehabilitation of
concussion and postconcussion syndrome
(PCS).
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’
The authors used broad protocols to
gather all currently available literature for
the systematic review. Databases used
were: MEDLINE and PubMed. Key terms
used were: “brain concussion/
complications OR brain concussion/
diagnosis OR brain concussion/ therapy
AND sports OR athletic injuries.
Secondary search terms included: postconcussion syndrome, trauma, symptoms,
metabolic, sports medicine, cognitive
behavioral therapy, treatment and
rehabilitation. Additional articles were
identified from the bibliographies of recent
reviews.”
For an article to be included it had to focus
on: “diagnosis, pathophysiology, and
treatment/ rehabilitation of concussion and
PCS…”
The authors did not specify any other
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-
68
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 end of
the study?
• Account for drop outs?
• Detection –
• Did the study selectively report the
results?
• Is there missing data?
inclusion or exclusion criteria in the review.
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).
Data summary tables were included in the
study. However, these were only
summaries of some of the articles
reviewed in this SR and did not disclose
any inclusion or exclusion criteria. The
summary tables were easy to follow.
•
Selection – Performance – Attrition –
Detection: In the studies chosen for
inclusion in this article the selection,
performance, attrition, and detection were
not discussed or reported on in detail
enough to provide answers for this section.
Are the results of this SR valid?
Appraisal Criterion
97. 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?
98. Did this study follow the Cochrane methods
selection process and did it identify all
Reader’s Comments
a. The types of studies included were
prospective cohort studies, retrospective
cohort studies, cross-sectional studies,
case series, and retrospective case series
b. Incorporating all types of studies
broadens the depth of the SR. However, in
this case it would have been beneficial for
the authors to report on the inclusion and
exclusion criteria of the articles used in
order to present the study as not being
biased toward any view
No. Bias may be present in this review of
69
relevant trials?
a. If not, what are the consequences for
this review’s results?
99. 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?
current literature.
No. One cannot replicate the methodology
behind this review and therefore cannot
add to it in the future as new research
comes out due to the inclusion and
exclusion criteria not being addressed
100.What was the quality of the individual studies Concerning participating in an exercise
included? Were the results consistent from
program: Past studies reported rest until
study to study? Did the investigators
asymptomatic was the best method for
provide details about the research validity
recovery, while recent studies have proven
or quality of the studies included in review?
subsymptom exercise assists in the
recovery of concussion symptoms.
101.Did the investigators address publication bias
No.
Are the valid results of this SR important?
Appraisal Criterion
102.
Were the results homogenous from
study to study?
a. If not, what are the consequences for
this review’s results?
103.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?
104.From the findings, is it apparent what the
cumulative weight of the evidence is?
Reader’s Comments
All results from the studies were
homogenous.
N/A
Yes, it is apparent through recent studies
subsymptom exercising along with a
combination of other treatments such as
vestibular, physical, manual, cognitive, and
psychological therapy are beneficial in the
treatment of concussions.
Can you apply this valid, important evidence from this SR in caring for
your patient/client? What is the external validity?
Appraisal Criterion
105.Is your patient different from those in this SR?
106.Is the treatment feasible in your setting? Do
you have the facilities, skill set, time, 3rd party
coverage to provide this treatment?
Reader’s Comments
Patients presenting with concussions I
have seen in clinic to date do not differ
than the patients described in the SR.
Treadmill testing and prescribing
subsymptom exercises is feasible. All the
outpatient orthopedic clinics I have visited
thus far into my career have the equipment
to manage the concussed population. PT
schools teach the required skill set to test
and treat this population. Third party
payers will pay for the evaluation and
skilled treatment provided. Most clinics I
70
have visited are limited in that they can
only provide the PT treatment for the
individual. Referral to other specialties,
such as cognitive behavioral therapy, may
be appropriate.
107.Does the intervention fit within your
Yes, as my goal as a clinician is to help
patient/client’s stated values or expectations? return the patient to play/work asap, and
a. If not, what will you do now?
the patients goal is usually to return to pay
and reduce symptoms ASAP as well.
What is the bottom line?
Appraisal Criterion
Summarize your findings and relate this back to clinical
significance
Reader’s Comments
Prolonged rest for patients diagnosed with
PCS has not proven to be beneficial.
Aerobic exercise therapy, cognitive
behavioral therapy and early education
have show to be effective treatment
methods. Treatment methods need to be
individualized for patients with PCS.
71
Name: David Scussel
Systematic Review – Evidence Appraisal Worksheet
Citation (use AMA or APA format):
Leddy, J. J., & Willer, B. (2013). Use of graded exercise testing in concussion
and return-to-activity management. Current Sports Medicine Reports, 12(6),
370-376.
Level of Evidence (Oxford scale):
3a, Systematic Review of 3b and better studies
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 define the focus of
the review: The purpose is “to review the
use of exercise testing to evaluate
physiologic recovery from the acute effects
of concussion and to review the theory and
evidence behind using individualized
aerobic exercise treatment in the return-toactivity (RTA) management of those with
concussion and post concussion
syndrome.”
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’
The authors stated in the article they
reviewed current research on the topic
matter and provided a reference list.
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 nonexperts, or both?
• Did the people assessing the
The criteria for include inclusion other than
the authors stating relevant research was
included was not disclosed.
The authors appear to have used only
peer reviewed articles in the compilation of
this article.
72
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 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).
Selection – Performance – Attrition –
Detection: In the studies chosen for
inclusion in this article the selection,
performance, attrition, and detection were
not discussed or reported on in detail
enough to provide answers for this section.
A data collection form was not included,
the studies were not coded to my
knowledge, and inclusion and exclusion
criteria were not disclosed
Are the results of this SR valid?
Appraisal Criterion
108.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?
109.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?
Reader’s Comments
a. The types of studies included were
cohort studies, case studies, retrospective
chart reviews, and randomized studies
b. Incorporating all types of studies
broadens the depth of the SR. However, in
this case it would have been beneficial for
the authors to report on the inclusion and
exclusion criteria of the articles used in
order to present the article as not being
biased toward any view
No. Bias may be present in this review of
current literature.
73
110.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?
111.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?
112.Did the investigators address publication bias
No. One cannot replicate the methodology
behind this review and therefore cannot
add to it in the future as new research
comes out.
The authors described past studies
depicting different methods of resolving
concussion symptoms. The authors then
present newer research describing newer
methods to resolving concussion
symptoms. The quality of individual studies
was not discussed. The new
methodologies discussed displayed similar
results. The authors did not provide details
about the research validity or quality of the
studies included in review.
No
Are the valid results of this SR important?
Appraisal Criterion
113.
Were the results homogenous from
study to study?
a. If not, what are the consequences for
this review’s results?
114.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?
115.From the findings, is it apparent what the
cumulative weight of the evidence is?
Reader’s Comments
All results from the studies were
homogenous.
N/A
No, as most of the studies reviewed were
not high quality. The methodology
reviewed appears to be newer and the
authors do state future randomized trails
are needed.
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
116.Is your patient different from those in this SR? Patient presenting with concussions I have
seen in clinic to date do not differ than the
patients described in the SR.
117.Is the treatment feasible in your setting? Do
Yes the intervention is both available and
you have the facilities, skill set, time, 3rd party affordable in all clinical settings I have
coverage to provide this treatment?
been exposed to as all outpatient ortho PT
clinics I have visited have a treadmill, the
Borg RPE is a measurement tool taught in
PT school, and the exercises prescribed to
patients can be performed independently.
As this treadmill test is considered part of
74
an evaluation and the exercises prescribed
are considered therapeutic 3rd party payers
will pay for the intervention.
118.Does the intervention fit within your
Yes, as my goal as a clinician is to help
patient/client’s stated values or expectations? return the patient to play/work asap, and
b. If not, what will you do now?
the patients goal is usually to return to pay
and reduce symptoms ASAP as well.
What is the bottom line?
Appraisal Criterion
Summarize your findings and relate this back to clinical
significance
Reader’s Comments
The Buffalo Concussion Treadmill Test (a
slight variation on the Balke exercise
treadmill test) appears safe and should be
used to establish an individualized
exercise duration and intensity, and be
used throughout the treatment phase in
order to monitor the patient’s symptoms
and tolerance of exercise. Individualized
progressive subsymptom threshold
exercise training appears to be safe and
expedites the recovery of PCS.
These methods used in my clinical rotation
appeared effective when used on multiple
individuals seen for concussions.
75
Name: David Scussel
Systematic Review – Evidence Appraisal Worksheet
Citation (use AMA or APA format):
Makdissi, M., Cantu, R. C., Johnston, K. M., McCrory, P., & Meeuwisse, W. H.
(2013). The difficult concussion patient: what is the best approach to
investigation and management of persistent (> 10 days) postconcussive
symptoms?. British Journal of Sports Medicine, 47(5), 308-313.
Level of Evidence (Oxford scale): 2a, Systematic Review of cohort studies,
retrospective cohort studies, and Level 2b and better studies
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 define the focus of
the review: To review available literature
on recommendations for management of
concussions symptoms lasting > 10 days.
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’
The authors used broad protocols to
gather all current available literature.
Databases used: MEDLINE, ISI Web of
Science, PubMed, and SportDiscus
Key words: concussion, mild traumatic
brain injury, head injury and sport or
athlete/athletic.
The key words were combined with terms
which would limit the search to difficult to
resolve concussions and management of
them: symptoms, complex, difficult,
prolonged, persistent, post-concussion
syndrome, investigation, imaging,
biomarker, gene/genetic, treatment,
medication, management, exercise and
rehabilitation.
“Reference lists from retrieved articles
were searched for additional articles, and
the authors’ own collections of articles
76
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 nonexperts, 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 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).
were included in the search strategy.”
Limited to: Past 10 years, English
language
The criteria for include inclusion other than
the authors stating relevant research was
included was not disclosed.
The authors appear to have used only
peer reviewed articles in the compilation of
this article.
Selection – Performance – Attrition –
Detection: In the studies chosen for
inclusion in this article the selection,
performance, attrition, and detection were
not discussed or reported on in detail
enough to provide answers for this section.
Data summary tables were included in the
study. However, these were only
summaries of some of the articles
reviewed in this SR and did not disclose
any inclusion or exclusion criteria. The
summary tables were easy to follow.
Are the results of this SR valid?
Appraisal Criterion
119.Is this a SR of randomized trials? Did they
limit this to high quality studies at the top of
Reader’s Comments
a. The types of studies included were
prospective cohort studies, retrospective
77
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?
120.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?
121.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?
cohort studies, cross-sectional studies,
case series, and retrospective case series
b. Incorporating all types of studies
broadens the depth of the SR. However, in
this case it would have been beneficial for
the authors to report on the inclusion and
exclusion criteria of the articles used in
order to present the study as not being
biased toward any view
No. Bias may be present in this review of
current literature.
No. One cannot replicate the methodology
behind this review and therefore cannot
add to it in the future as new research
comes out due to the inclusion and
exclusion criteria not being addressed
122.What was the quality of the individual studies Concerning participating in an exercise
included? Were the results consistent from
program: Dated studies reported rest until
study to study? Did the investigators
asymptomatic was the best method for
provide details about the research validity
recovery, while recent studies have proven
or quality of the studies included in review?
subsymptom exercise assists in the
recovery of prolonged concussion
symptoms.
123.Did the investigators address publication bias
No.
Are the valid results of this SR important?
Appraisal Criterion
Reader’s Comments
124.
Were the results homogenous from All results from the studies were
study to study?
homogenous.
a.
If not, what are the consequences for
this review’s results?
125.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?
126.From the findings, is it apparent what the
cumulative weight of the evidence is?
N/A
Yes, it is apparent through recent studies
subsymptom exercising along with a
combination of other treatments such as
vestibular, physical, manual, cognitive, and
psychological therapy are beneficial in the
treatment of concussions.
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
78
127.Is your patient different from those in this SR?
patients presenting with concussions I
have seen in clinic to date do not differ
than the patients described in the SR.
128.Is the treatment feasible in your setting? Do
Treadmill testing and prescribing
you have the facilities, skill set, time, 3rd party subsymptom exercises is feasible. All the
coverage to provide this treatment?
outpatient orthopedic clinics I have visited
thus far into my career have the equipment
to manage the concussed population. PT
schools teach the required skill set to test
and treat this population. Third party
payers will pay for the evaluation and
skilled treatment provided. Most clinics I
have visited are limited in that they can
only provide the PT treatment for the
individual and may need to refer out of the
facility to address cognitive and
psychological issues if the clinic is not
located in a hospital.
129.Does the intervention fit within your
Yes, as my goal as a clinician is to help
patient/client’s stated values or expectations? return the patient to play/work asap, and
c. If not, what will you do now?
the patient’s goal is usually to return to pay
and reduce symptoms ASAP as well.
What is the bottom line?
Appraisal Criterion
Summarize your findings and relate this back to clinical
significance
Reader’s Comments
Controversial to dated studies (>10 years
old), prolonged rest has not proven
beneficial in the treatment of prolonged
concussion symptoms. Providing a
subsymptom exercise prescription along
with a combination of other treatments
such as vestibular, physical, manual,
cognitive, and psychological therapy are
beneficial in the treatment of concussions.
79
#
Study
1
Baker, Freitas,
Leddy, Kozlowski,
& Willer, (2012)
2
Darling, et al.
(2014)
Oxford
Level
2b
PEDro
N/A
2b
4
Outcome
Measures
Purpose
Results
To show functional outcomes (i.e.
return to work, athletic activities,
and other ADLs) of those with
postconcussion syndrome (PCS)
when prescribed a progressive
subsymptom threshold exercise
program.
To evaluate return to play (RTP)
decision outcomes made from a
combination of the Buffalo
Concussion Treadmill Test
(BCTT) and Zurich guidelines.
The secondary purpose was to
determine if a computerized
neuropsychological test (cNP)
predicted new or increased
learning problems in the
classroom.
To assess exercise intolerance in
patients with postconcussion
syndrome (PCS) as seen by
increases in concussion
symptoms during treadmill
testing.
Functional outcomes
(i.e. return to work,
athletic activities, and
other ADLs)
Treadmill test duration
Max heart rate
Rate of perceived
exertion (RPE)
through the Borg
Scale
Max systolic BP
Max diastolic BP
The PCS group had significantly
decreased tolerance to the treadmill test
than their healthy counterparts. The PCS
group had significantly reduced testing
duration (9.4 minutes less on average,
P<0.001), max heart rate (P<0.001), max
systolic BP (P=0.02), and max diastolic
BP (P=0.03).
Yes
RTR for the treadmill test revealed
maximal heart rate to have good RTR and
moderate RTR for maximal SBP. DBP
proved to not be a reliable reproducible
measurement. The Balke exercise
treadmill test for symptom identification in
concussed patients has “sufficient
maximum heart rate RTR,” and appears
to be a more reliable method for tracking
the progress of athletes trying to RTP
than the stepwise program, which is
subjective.
fMRI results before treatment: No
difference between the exercise and
Yes
RTP outcome
New or increased
learning problems in
the classroom
3
Kozlowski,
Graham, Leddy,
Devinney-Boymel,
& Willer, (2013)
2b
5
4
Leddy, Baker,
Kozlowski, Bisson,
& Willer, (2011)
1b
5
To assess the retest reliability
(RTR) of a standardized graded
treadmill exercise test in
determining return to play (RTP)
status of both concussed athletes
and nonathletes.
RTR
5
Leddy, et al. (2013)
2b
7
To compare before and after fMRI
results between subjects with
Brain activity as seen
through fMRI
80
Twenty-seven (77%) P-PCS and 14
(64%) PCS group participants who
participated in the exercise program
returned to their prior level of functioning.
Of those who declined to participate in the
exercise program 1 (20%) returned to
their prior level of functioning.
All subjects returned to sport a week after
successfully completing the BCTT and
progressing through the stepwise Zurich
guidelines. About 39% reported new or
increased problems in the classroom after
being cleared to return. cNP testing was
not proven to be significant in predicting
RTP success or predicting new or
increased learning problems in the
classroom.
Answer
to PICO
Question
Yes
Yes
Yes
postconcussion syndrome (PCS)
who received an exercise
program, subjects with PCS who
received a placebo intervention,
and a healthy control group.
6
Leddy, et al. (2010)
1b
4
To show the safety and
effectiveness of reducing
concussive symptoms in
individuals with post concussion
syndrome (PCS) through the
implementation a progressive
subsymptom threshold exercise
training (SSTET) program.
Reported adverse
reactions from SSTET
Functional outcomes
(return to work, school
and athletic activities)
7
Leddy, Sandhu,
Sodhi, Baker, &
Willer, (2012)
2a
N/A
To review available literature on
recommendations for
rehabilitation of concussion and
postconcussion syndrome (PCS).
Recommendations for
rehabilitation of
concussion and (PCS)
8
Leddy, & Willer,
(2013)
3a
N/A
“To review the use of exercise
testing to evaluate physiologic
recovery from the acute effects of
concussion and to review the
theory and evidence behind using
individualized aerobic exercise
treatment in the return-to-activity
(RTA) management of those with
concussion and post concussion
syndrome.”
Adverse reactions
from treadmill testing
and individualized
aerobic exercise
treatment
9
Makdissi, Cantu,
Johnston, McCrory,
& Meeuwisse,
(2013)
2a
N/A
To review available literature on
recommendations for
management of concussions
symptoms lasting > 10 days.
Reported
recommendations for
concussion
management
81
placebo PCS groups, the control group
had greater activation in the posterior
cingulate gyrus, lingual gyrus, and
cerebellum. fMRI results after treatment:
No differences between the exercise PCS
group and the control group, the placebo
PCS group had significantly (P<0.05) less
cerebellar activity.
All 12 subjects were able to follow the
exercise prescription with no adverse
reactions. Significant differences:
Baseline and end treatment GSC
(P=0.002), exercise duration increased
significantly (P=0.001), and peak heart
rate and SBP with exercise increase
significantly (both P<0.001). The phone
follow-up revealed all subjects completely
returned to work, school, and athletic
activities.
Prolonged rest for patients diagnosed with
PCS has not proven to be beneficial.
Aerobic exercise therapy, cognitive
behavioral therapy and early education
have show to be effective treatment
methods. Treatment methods need to be
individualized for patients with PCS.
The Buffalo Concussion Treadmill Test (a
slight variation on the Balke exercise
treadmill test) appears safe and should be
used to establish an individualized
exercise duration and intensity, and be
used throughout the treatment phase in
order to monitor the patient’s symptoms
and tolerance of exercise. Individualized
progressive subsymptom threshold
exercise training appears to be safe and
expedites the recovery of PCS.
Prolonged rest has not proven beneficial
in the treatment of PCS. Providing a
subsymptom exercise prescription along
with a combination of other treatments
such as vestibular, physical, manual,
cognitive, and psychological therapy are
beneficial in the treatment of concussions.
Yes
Yes
Yes
No
Figure 1. Database search results
PubMed
CINAHL
Cochrane
Google
Scholar
MeSH Database
Four keyword
searches
No limits
3
7
47 71
Keyword Search
Four keyword
searches
No limits
3
5
28 17
MeSH Database &
Keyword Search
Four keyword
searches
No limits
0
0
0
4
Total Search Results:
All searches included
‘concussion’
Follow key below:
2
Relevant articles by title and abstract
(Duplicate articles between searches were taken into account)
8 Supporting articles found on heart rate,
the autonomic nervous system, exercise,
the pediatric population, and an
international consensus statement
regarding concussions
82
treadmill, exercise,
training, testing,
concussion
Title Search
Cited references
searched
15
9 Primary articles found related to the
PICO question: Is subsymptom threshold
exercise training a safe and effective
treatment for returning a 17 year old male
athlete with postconcussion syndrome to
sport?
Keywords:
Treadmill
training
Treadmill
testing
Exercise
training
Exercise
testing
References
American Physical Therapy Association. (2001). Guide to Physical Therapist Practice,
(2nd ed.). Physical Therapy, 81:9-744.
Baker, J. G., Freitas, M. S., Leddy, J. J., Kozlowski, K., & Willer, B. S. (2012). Return to
full functioning after graded exercise assessment and progressive exercise treatment
of postconcussion syndrome. Rehabilitation Research and Practice, 2012, 1-7.
Boake, C., McCauley, S. R., Levin, H. S., Pedroza, C., Contant, C. F., Song, J. X.,
Brown, S. A., Goodman, H., Brundage, S. I., & Diaz-Marchan, P. J. (2005).
Diagnostic criteria for postconcussional syndrome after mild to moderate traumatic
brain injury. The Journal of Neuropsychiatry and Clinical Neurosciences, 17(3), 350356.
Darling, S. R., Leddy, J. J., Baker, J. G., Williams, A. J., Surace, A., Miecznikowski, J.
C., & Willer, B. (2014). Evaluation of the Zurich Guidelines and exercise testing for
return to play in adolescents following concussion. Clinical Journal of Sport
Medicine, 24(2), 128-133.
Kozlowski, K. (2014). Exercise and Concussion, Part 2: Exercise as a therapeutic
intervention. International Journal of Athletic Therapy & Training, 19(2), 28-32.
Kozlowski, K., Graham, J., Leddy, J. J., Devinney-Boymel, L., & Willer, B. S. (2013).
Exercise intolerance in individuals with postconcussion syndrome. Journal of Athletic
Training, 48(5), 627-635.
Leddy, J. J., Baker, J. G., Kozlowski, K., Bisson, L., & Willer, B. (2011). Reliability of a
graded exercise test for assessing recovery from concussion. Clinical Journal of
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