HealthyNCT06035484
Effect of Seat Height and Angle on Wheelchair Foot Propulsion
A study testing Seat height and Seat inclination in people with Healthy, run by University of Manitoba at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Seat height and Seat inclination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 20 Apr 2023to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy
- Being tested
- Seat height, Seat inclination
- Keywords
- Manual Wheelchair, Bilateral propulsion, Foot propulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seat heightOther
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 inclinationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| LL & 0 | Experimental | Wheelchair seat height will be positioned at lower leg length and set inclination will be zero Receives: Other: Seat height; Other: Seat inclination |
| LL + 1 | Experimental | Wheelchair seat height will be positioned at the participant's leg length plus one inch with an inclination of zero Receives: Other: Seat height |
| LL - 1 | Experimental | Wheelchair seat height will be positioned at the participant's leg length minus one inch with an inclination of zero Receives: Other: Seat height |
| LL - 2 | Experimental | Wheelchair seat height will be positioned at the participant's leg length minus two inches with an inclination of zero Receives: Other: Seat height |
| LL - 3 | Experimental | Wheelchair seat height will be positioned at the participant's leg length minus three inches with an inclination of zero Receives: Other: Seat height |
| 3 degrees Inclination | Experimental | Wheelchair seat height will be positioned at the participant's leg length with a forward seat inclination of 3 degrees Receives: Other: Seat inclination |
| 6 degrees Inclination | Experimental | Wheelchair seat height will be positioned at the participant's leg length with a forward seat inclination of 6 degrees Receives: Other: Seat inclination |
| 9 degrees Inclination | Experimental | Wheelchair seat height will be positioned at the participant's leg length with a forward seat inclination of 9 degrees Receives: Other: Seat inclination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propulsion speed
Speed will be determined via video recording. Two outcomes will be determined initial 10m and total test course
Measured: ~30-60 seconds
Knee range of motion
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.
Measured: ~30-60 seconds
Effectiveness of foot propulsion gait
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.
Measured: ~30-60 seconds
Perceived difficulty with foot propulsion
Participant will provide subjective evaluations of how difficult they found foot propulsion after each trial, using Perceived Difficulty Questionnaire (Heinrichs et al., 2021).
Measured: ~30-60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start20 Apr 2023
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Within-subjects repeated measures design
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ed Giesbrecht, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035484
- Sponsor's protocol ID
- HS25835 (H2023:027)
- Status last verified
- May 2024
- First submitted
- 7 Feb 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared outside of the principle and student investigator's conducting this study.
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.
PubMed 23499781Heinrichs 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.
PubMed 32238086
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Seat Height and Angle on Wheelchair Foot Propulsion
- ClinicalTrials.gov ID
- NCT06035484
- Acronym / sponsor ID
- HS25835 (H2023:027)
- Conditions
- Healthy
- Keywords
- Manual Wheelchair, Bilateral propulsion, Foot propulsion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Within-subjects repeated measures design
| Arm | Type | Receives |
|---|---|---|
| LL & 0 | Experimental | Other: Seat height, Other: Seat inclinationWheelchair seat height will be positioned at lower leg length and set inclination will be zero |
| LL + 1 | Experimental | Other: Seat heightWheelchair seat height will be positioned at the participant's leg length plus one inch with an inclination of zero |
| LL - 1 | Experimental | Other: Seat heightWheelchair seat height will be positioned at the participant's leg length minus one inch with an inclination of zero |
| LL - 2 | Experimental | Other: Seat heightWheelchair seat height will be positioned at the participant's leg length minus two inches with an inclination of zero |
| LL - 3 | Experimental | Other: Seat heightWheelchair seat height will be positioned at the participant's leg length minus three inches with an inclination of zero |
| 3 degrees Inclination | Experimental | Other: Seat inclinationWheelchair seat height will be positioned at the participant's leg length with a forward seat inclination of 3 degrees |
| 6 degrees Inclination | Experimental | Other: Seat inclinationWheelchair seat height will be positioned at the participant's leg length with a forward seat inclination of 6 degrees |
| 9 degrees Inclination | Experimental | Other: Seat inclinationWheelchair seat height will be positioned at the participant's leg length with a forward seat inclination of 9 degrees |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seat heightSeat 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. | Other | LL & 0, LL + 1, LL - 1, LL - 2, LL - 3 |
| Seat inclinationSeat 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. | Other | 3 degrees Inclination, 6 degrees Inclination, 9 degrees Inclination, LL & 0 |
Primary outcome
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
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.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 23499781Askari 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.
- Background: PubMed 32238086Heinrichs 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.
- Individual participant dataSharing planned: No. Data will not be shared outside of the principle and student investigator's conducting this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seat height and Seat inclination in people with Healthy, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propulsion speed (time frame: ~30-60 seconds). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06035484, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.