- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03330912
The Influence of Seat Height on Hemiplegic-pattern Propulsion of Manual Wheelchairs
Study Overview
Status
Conditions
Detailed Description
Many people who have suffered a stroke require a wheelchair for mobility. Hemiplegia is a common result of stroke.Many people with hemiplegia propel themselves using their sound-side arms and legs ("hemiplegic-pattern propulsion") in manual wheelchairs.Often people using this pattern are prescribed wheelchairs with a reduced seat height to facilitate foot propulsion. Despite the seeming obviousness of the need to lower the seat height for people who use foot propulsion,there is little available evidence to help establish optimal wheelchair seat height. The study objective is to test the hypothesis that there is an optimum wheelchair seat height (expressed as a percentage of the lower leg length) for hemiplegic-pattern wheelchair propulsion. The investigators expect that the optimum seat height will be lower than that usually used for wheelchairs that are hand-propelled.
A single-subject design with able-bodied participants will be used to investigate 5 randomized seat heights. The 5 seat heights will be set relative to the subjects leg length at a single 60 minute data collection session All measures will be obtained during one session. The optimal seat height will be chosen based on wheelchair propulsion speed, push frequency and effectiveness over 10m going forward on smooth surface, and 5m going backwards over a soft surface.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 4K4
- Nova Scotia Rehabilitation and Arthritis Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- willing to participate
- is right-hand dominant (to simplify wheelchair and laboratory set-up)
- has a subjective unshod height of ≤ 183 cm (6'0")
- is able to be comfortably seated in the manual wheelchair used for the study
- is 18 years of age or older, is alert and cooperative
- is competent to provide informed consent
- is able to communicate in English
- does not have an unstable medical condition
Exclusion Criteria:
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Seat Height Intervention
Randomly assigned 5 wheelchair seat heights ranging from very low (2" below) to very high (2" above) the lower leg length of the participant.
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Seat height set relative to participant's leg length with neutral set at the measured lower leg length
Seat height set relative to participant's leg length, 2" below the measured lower leg length
Seat height set relative to participant's leg length, 1" below the measured lower leg length
Seat height set relative to participant's leg length, 2" above the measured lower leg length
Seat height set relative to participant's leg length, 1" above the measured lower leg length
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
speed (m/s)
Time Frame: same day measure obtained immediately after seat adjustment, approximately 10 minutes
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wheelchair propulsion speed over 10 m forward and 5 m backward
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same day measure obtained immediately after seat adjustment, approximately 10 minutes
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push frequency (cycles per second)
Time Frame: same day measure obtained immediately after seat adjustment, approximately 10 minutes
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number of foot cycles completed over the 10 m forward and 5 m backward
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same day measure obtained immediately after seat adjustment, approximately 10 minutes
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Propulsion effectiveness
Time Frame: same day measure obtained immediately after seat adjustment, approximately 10 minutes
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distance travelled per foot propulsion cycle
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same day measure obtained immediately after seat adjustment, approximately 10 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
forward propulsion wheelchair skills test score
Time Frame: same day measure obtained immediately after seat adjustment, approximately 10 minutes
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fail, pass with difficulty or pass for wheeling forward 10 m
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same day measure obtained immediately after seat adjustment, approximately 10 minutes
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propulsion difficulty questionnaire
Time Frame: same day measure obtained immediately after seat adjustment, approximately 10 minutes
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Investigator developed questionnaire asking how difficult it was to perform the propulsion test.
The participant will self-report his/her level of difficulty for this skill using a five-point Likert scale (1 =very easy, 2=somewhat easy, 3=neither easy nor difficult, 4= somewhat difficult and 5=very difficult).
A single number will be reported.
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same day measure obtained immediately after seat adjustment, approximately 10 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lee Kirby, MD, Nova Scotia Health Authority, Dalhousie University
Publications and helpful links
General Publications
- 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.
- 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 2 - wheeling backward on a soft surface. Disabil Rehabil Assist Technol. 2022 Apr;17(3):325-330. doi: 10.1080/17483107.2020.1782490. Epub 2020 Jun 27.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1022716
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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