- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06035484
Effect of Seat Height and Angle on Wheelchair Foot Propulsion
The purpose of the project is to explore the effect of differences in seat height and seat angle on bilateral foot propulsion using a manual wheelchair. The objectives of the study are to determine whether differences in seat height and seat angle impact: a) propulsion speed; b) knee range of motion used during propulsion; c) effectiveness of foot propulsion gait; and d) perceived difficulty with foot propulsion.
A repeated measures designs allows comparison between 5 different seat height conditions and 4 different seat angle conditions to determine whether there are significant differences in outcome, and if so, which conditions provide better outcomes. Participants will propel a customized MWC through a standardized course using each seat configuration; the sequence will be randomized to reduce any learning effects.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3E 0T6
- University of Manitoba
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- student in College of Rehabilitation Sciences enrolled in Master of Occupational Therapy, Master of Physical Therapy, or Bachelor of Respiratory Therapy program at the University of Manitoba.
- Able-bodied individuals
Exclusion Criteria:
- Students whose hip width exceeds 21 inches or lower leg length is shorter than 16 inches will be excluded as the test manual wheelchair will not accommodate these dimensions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: LL & 0
Wheelchair seat height will be positioned at lower leg length and set inclination will be zero
|
Seat height of a manual wheelchair will be changed according the different arms specified.
The participant will complete a course in the manual wheelchair with each arm.
Seat inclination of a manual wheelchair will be changed according the different arms specified.
The participant will complete a course in the manual wheelchair with each arm.
|
|
Experimental: LL + 1
Wheelchair seat height will be positioned at the participant's leg length plus one inch with an inclination of zero
|
Seat height of a manual wheelchair will be changed according the different arms specified.
The participant will complete a course in the manual wheelchair with each arm.
|
|
Experimental: LL - 1
Wheelchair seat height will be positioned at the participant's leg length minus one inch with an inclination of zero
|
Seat height of a manual wheelchair will be changed according the different arms specified.
The participant will complete a course in the manual wheelchair with each arm.
|
|
Experimental: LL - 2
Wheelchair seat height will be positioned at the participant's leg length minus two inches with an inclination of zero
|
Seat height of a manual wheelchair will be changed according the different arms specified.
The participant will complete a course in the manual wheelchair with each arm.
|
|
Experimental: LL - 3
Wheelchair seat height will be positioned at the participant's leg length minus three inches with an inclination of zero
|
Seat height of a manual wheelchair will be changed according the different arms specified.
The participant will complete a course in the manual wheelchair with each arm.
|
|
Experimental: 3 degrees Inclination
Wheelchair seat height will be positioned at the participant's leg length with a forward seat inclination of 3 degrees
|
Seat inclination of a manual wheelchair will be changed according the different arms specified.
The participant will complete a course in the manual wheelchair with each arm.
|
|
Experimental: 6 degrees Inclination
Wheelchair seat height will be positioned at the participant's leg length with a forward seat inclination of 6 degrees
|
Seat inclination of a manual wheelchair will be changed according the different arms specified.
The participant will complete a course in the manual wheelchair with each arm.
|
|
Experimental: 9 degrees Inclination
Wheelchair seat height will be positioned at the participant's leg length with a forward seat inclination of 9 degrees
|
Seat inclination of a manual wheelchair will be changed according the different arms specified.
The participant will complete a course in the manual wheelchair with each arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Propulsion speed
Time Frame: ~30-60 seconds
|
Speed will be determined via video recording.
Two outcomes will be determined initial 10m and total test course
|
~30-60 seconds
|
|
Knee range of motion
Time Frame: ~30-60 seconds
|
Xsens sensors and mobile app will be used to determine the positions of the thigh and lower leg and knee joint angle will be obtained from the difference between these positions.
|
~30-60 seconds
|
|
Effectiveness of foot propulsion gait
Time Frame: ~30-60 seconds
|
Evaluated using the Wheelchair Propulsion Test developed by Askari et al. (2013).
Simple, valid and reliable measure of propulsion for either upper or lower extremity propulsion techniques.
|
~30-60 seconds
|
|
Perceived difficulty with foot propulsion
Time Frame: ~30-60 seconds
|
Participant will provide subjective evaluations of how difficult they found foot propulsion after each trial, using Perceived Difficulty Questionnaire (Heinrichs et al., 2021).
|
~30-60 seconds
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Askari S, Kirby RL, Parker K, Thompson K, O'Neill J. Wheelchair propulsion test: development and measurement properties of a new test for manual wheelchair users. Arch Phys Med Rehabil. 2013 Sep;94(9):1690-8. doi: 10.1016/j.apmr.2013.03.002. Epub 2013 Mar 14.
- Heinrichs ND, Kirby RL, Smith C, Russell KFJ, Theriault CJ, Doucette SP. Effect of seat height on manual wheelchair foot propulsion, a repeated-measures crossover study: part 1 - wheeling forward on a smooth level surface. Disabil Rehabil Assist Technol. 2021 Nov;16(8):831-839. doi: 10.1080/17483107.2020.1741036. Epub 2020 Apr 2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HS25835 (H2023:027)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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