The Influence of Seat Height on Hemiplegic-pattern Propulsion of Manual Wheelchairs
Primary Purpose
Wheelchairs, Hemiplegia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Neutral seat height
Very low seat height
Low seat height
Very high seat height
High seat height
Sponsored by
About this trial
This is an interventional treatment trial for Wheelchairs
Eligibility Criteria
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:
-
Sites / Locations
- Nova Scotia Rehabilitation and Arthritis Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Seat Height Intervention
Arm Description
Randomly assigned 5 wheelchair seat heights ranging from very low (2" below) to very high (2" above) the lower leg length of the participant.
Outcomes
Primary Outcome Measures
speed (m/s)
wheelchair propulsion speed over 10 m forward and 5 m backward
push frequency (cycles per second)
number of foot cycles completed over the 10 m forward and 5 m backward
Propulsion effectiveness
distance travelled per foot propulsion cycle
Secondary Outcome Measures
forward propulsion wheelchair skills test score
fail, pass with difficulty or pass for wheeling forward 10 m
propulsion difficulty questionnaire
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03330912
Brief Title
The Influence of Seat Height on Hemiplegic-pattern Propulsion of Manual Wheelchairs
Official Title
The Influence of Seat Height on Hemiplegic-pattern Propulsion of Manual Wheelchairs
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lee Kirby
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the effect of seat height on hemiplegic-pattern wheelchair propulsion. Each subject will act as their own control and measures will be obtained in a one sixty minute session. Five seat heights relative to the subject's leg length will be measured in a random order to see the effect on forward and backwards wheelchair propulsion.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wheelchairs, Hemiplegia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single subject - participants will be compared to themselves. STROBE guidelines will be followed.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Seat Height Intervention
Arm Type
Experimental
Arm Description
Randomly assigned 5 wheelchair seat heights ranging from very low (2" below) to very high (2" above) the lower leg length of the participant.
Intervention Type
Device
Intervention Name(s)
Neutral seat height
Intervention Description
Seat height set relative to participant's leg length with neutral set at the measured lower leg length
Intervention Type
Device
Intervention Name(s)
Very low seat height
Intervention Description
Seat height set relative to participant's leg length, 2" below the measured lower leg length
Intervention Type
Device
Intervention Name(s)
Low seat height
Intervention Description
Seat height set relative to participant's leg length, 1" below the measured lower leg length
Intervention Type
Device
Intervention Name(s)
Very high seat height
Intervention Description
Seat height set relative to participant's leg length, 2" above the measured lower leg length
Intervention Type
Device
Intervention Name(s)
High seat height
Intervention Description
Seat height set relative to participant's leg length, 1" above the measured lower leg length
Primary Outcome Measure Information:
Title
speed (m/s)
Description
wheelchair propulsion speed over 10 m forward and 5 m backward
Time Frame
same day measure obtained immediately after seat adjustment, approximately 10 minutes
Title
push frequency (cycles per second)
Description
number of foot cycles completed over the 10 m forward and 5 m backward
Time Frame
same day measure obtained immediately after seat adjustment, approximately 10 minutes
Title
Propulsion effectiveness
Description
distance travelled per foot propulsion cycle
Time Frame
same day measure obtained immediately after seat adjustment, approximately 10 minutes
Secondary Outcome Measure Information:
Title
forward propulsion wheelchair skills test score
Description
fail, pass with difficulty or pass for wheeling forward 10 m
Time Frame
same day measure obtained immediately after seat adjustment, approximately 10 minutes
Title
propulsion difficulty questionnaire
Description
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.
Time Frame
same day measure obtained immediately after seat adjustment, approximately 10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Kirby, MD
Organizational Affiliation
Nova Scotia Health Authority, Dalhousie University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nova Scotia Rehabilitation and Arthritis Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 4K4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32238086
Citation
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.
Results Reference
background
PubMed Identifier
32594783
Citation
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.
Results Reference
background
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The Influence of Seat Height on Hemiplegic-pattern Propulsion of Manual Wheelchairs
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