Omnibus Running
Research Protocol
Please see attached document for signed cover page
1. Is this project externally funded?
No.
2. Project Staff
Please list personnel, including students, who will be working with human subjects on this protocol (insert
additional rows as needed):
NAME
Irene Davis
Allison Altman
Brad Bowser
Rebecca Fellin
Richard Willy
Jess Romboch
Matthew Westcott
ROLE
Primary Investigator
Secondary Investigator
Secondary Investigator
Secondary Investigator
Secondary Investigator
Research Assistant
Research Assistant
HS TRAINING COMPLETE?
Yes
Yes
Yes
Yes
Yes
Yes
Yes
3. Special Populations
Does this project involve any of the following:
Research on Children? No
Research with Prisoners? No
Research with any other vulnerable population (please describe)? No
4. RESEARCH ABSTRACT
1) Analysis of the mechanics of normal running may include video analysis, measurement of joint
angles, ground reaction forces, electrical activity of muscles and tibial shock. The purpose of this
study is to examine one or more of these characteristics of movement in healthy, uninjured
individuals
The data may be used for the following purposes:
1) Development of normative data
2) Comparisons of gender
3) Comparisons of age
4) Comparisons of speed (between 2.68-3.80 meters/second)
5) Comparisons of footwear/non-custom insoles.
6) Comparison of running mechanics over time
The purpose of the study will be indicated on the informed consent form.
Data will be collected while subjects are running overground or on a treadmill. The researcher will indicate
with a check mark which running protocol will be utilized for the pilot session by indicating in the right
margin the applicable protocol on the Human Subjects Informed Consent document. The subject will
initial in the right margin of the informed consent document next to the indicated protocol.
5. PROCEDURES
All testing will take place at the Motion Analysis Laboratory or the Instrumented Treadmill Laboratory in
the Physical Therapy Department at the University of Delaware. Prior to experimental testing, the
investigator will indicate which testing protocol will be utilized by circling the appropriate number on the
Human Subjects Informed Consent Document. Informed consent will be obtained from each subject
(Appendix A). The subjects will have the opportunity to have any questions answered to their
satisfaction.
Subjects must be healthy (no injury, illness, or any condition, which might affect their ability to run). If the
subject will be tested while running on a treadmill, they must be able to run for 10 minutes on the
instrumented treadmill at a speed in the range of 2.68-3.80 meters/second (6.0-8.5 mph). Familiarity with
treadmill running will be determined by a visual analog scale (scoring greater than 7/10) which each
subject will complete prior to participation in the study (Appendix B). If the subject will be tested while
running overground, they must also be capable of running approximately 75 feet through the Motion
Analysis Laboratory at a speed in the range of 2.68-3.80 meters/second (6.0-8.5 mph).
Subjects will complete one of the following testing protocols: 1) Overground Running and 2) Treadmill
Running
1) Overground Running
Kinematic data will be collected using an 8-camera VICON motion analysis system (Oxford Metrics
Group, Oxford, England). Ground reaction force data will be collected via a forceplate (Bertec,
Worthington, OH) mounted in the center of the runway of the Motion Analysis Laboratory in McKinly
Laboratory. Accelerometer data will be collected utilizing a tri-axial accelerometer (PCB Piezotronics,
Depew, NY). All kinematic data will be collected at 200 or 240 Hz. Forceplate and accelerometer data will
be collected at 1000 or 1200 Hz. Subjects will then be asked to run along a 75-foot runway at a
prescribed speed. The prescribed speed will be in the range of 2.68-4.47 meters/second (6.0-10.0 mph).
Speed will be monitored via photocells mounted on the wall of the Motion Analysis Laboratory. We will
record the speed for each trial and provide verbal feedback to help subjects run the appropriate speed for
this study. We will only accept trials that are run at the prescribed speed +/-5%. Ten trials will be
collected. It is possible that subjects will be required to run across the lab more than 10 times in order to
obtain the ten acceptable trials.
2) Treadmill Running
Kinematic data will be collected using an 8-camera VICON motion analysis system (Oxford Metrics
Group, Oxford, England). Ground reaction force data will be collected via an instrumented treadmill
(AMTI, Watertown, MA). Accelerometer data will be collected utilizing a tri-axial accelerometer (PCB
Piezotronics, Depew, NY). All kinematic data will be collected at 200 or 240 Hz. Forceplate and
accelerometer data will be collected at 1000 or 1200 Hz. The prescribed running speed will be in the
range of 2.68-4.47 meters/second (6.0-10.0 mph). Treadmill speed will be controlled by the investigator.
The treadmill may be halted at anytime by either the subject or the investigator via emergency stop
buttons. A force plate mounted within the instrumented treadmill will record ground reaction forces as the
subject traverses it.
Subjects’ data will be collected using one, or a combination of the following data collection method(s):
a) Running Force Analysis:
We will have the subject stand on a plate in the lab floor or on the treadmill, which measures force,
and record a data trial. Subjects will then be asked to complete the running protocol as described
above as data are collected.
b) Running Muscle Activity Analysis:
Surface mounted electromyographic (EMG) sensors will be placed several of the subject’s
muscles to measure electrical signals going to the muscles. The EMG sensors are 1.5 in. x 0.75
in. x 0.25 in. Before the EMG sensors are placed on the subject’s leg, small areas over each of the
muscles to be measured will be shaved with a new disposable razor. Next, the subject’s skin will
be wiped with a paper towel to brush away hair and dead skin cells. Then the skin will be wiped
with rubbing alcohol so that the sensors make good contact. (The part of the sensor that touches
the subject’s skin will also be cleaned with rubbing alcohol.) Then tape and elastic bands will be
used to hold the sensors in place. Subjects will then be asked to complete the running protocol as
described above as data are collected.
c) Running Shock Analysis:
An accelerometer, (PCB, Depew, NY) a small device measuring shock, will be placed on the
subject’s leg just above the ankle. Subjects will then be asked to complete the running protocol as
described above as data are collected
d) Running Motion Analysis:
Reflective markers will be placed on the lower legs and pelvis. Next, we will have the subject
stand on a section of the lab floor or treadmill in view of eight cameras and record a data trial.
Subjects will then be asked to complete the running protocol as described above as data are
collected.
f) Running Video Analysis:
Subjects’ anonymity will be preserved by video taping from the shoulders down to their feet.
Subjects will be asked to complete the running protocol as described above as they are
videotaped.
6. STUDY POPULATION AND RECRUITMENT
All subjects recruited will be between 18 and 50 years old, currently running at least six miles per week
and familiar with treadmill running, if indicated. Subjects will be recruited from local running clubs and
races, the University of Delaware campus and surrounding communities. Subjects must be healthy, free
of illness or any other medical condition. Flyers will be posted around the University of Delaware campus
to advertise the study (Appendix C). Both males and females will serve as subjects. Subjects must be
healthy, free of illness or any other medical condition. If the subject experiences any pain or discomfort
during the testing procedure(s), the data collection will be stopped immediately. We plan to collect up to
150 subjects for this study.
7. RISKS AND BENEFITS
There is a possibility that a subject may slip, trip, or fall while on the treadmill or running through the
laboratory. Precautions to reduce the possibilities of these injuries will be taken. For safety treadmill
speeds will be increased and decreased gradually. The treadmill also has a handrail that subjects may
use to steady themselves, as well as an emergency stop button available if subjects need to stop the
treadmill. There will be two people present at all times during data collection to monitor the subjects. If
needed, first aid will be administered. It is unlikely, but possible, a subject may have some mild irritation
from the tape adhesive on his/her skin.
Benefits
Subjects will not receive any immediate benefits due to their participation in this study. However, results
from this study will help to improve the understanding of normal running mechanics.
8. COMPENSATION
Subjects will be compensated $25 for each testing session.
9. DATA
Only personnel collaborating with Dr. Irene Davis along with the individuals in the research office are
permitted to view the research records. The principal investigator will control access to the records, which
will be stored in a secure area. In the event that the data are used for publication purposes, a code
number will be assigned to each subject’s data in order to maintain subject confidentiality in reporting
results. The data will be stored indefinitely for future reference, on a password protected server, which is
only accessible by the study investigators. Each subject will be identified by a code number.
9. CONFIDENTIALITY
All subjects’ data will be identified by a subject code. Any photographs and videotaping will be limited to a
view from the shoulders to the feet so that the identification of the subject is protected.
10. CONSENT and ASSENT
__X__Consent forms will be used and are attached for review.
11. Other IRB Approval
Has this protocol been submitted to any other IRBs?
No.