- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04998539
Effect of Travel Direction, Body Position and Technique on the Ease of Getting an Occupied Wheelchair Over a Soft Surface
September 21, 2022 updated by: Lee Kirby, Nova Scotia Health Authority
Effect of Travel Direction, Body Position and Technique on the Ease of a Caregiver Getting an Occupied Wheelchair Over a Soft Surface: a Randomized Crossover Trial
Wheelchair skills training is an important step in the wheelchair provision process.
Caregivers play an important role in the lives of wheelchair users but very little is known about wheelchair skills training for caregivers.
The goal of the study is to understand the effect of wheelchair travel direction, wheelchair occupant body position and technique used by caregivers on the ease of getting an occupied wheelchair over a soft surface.
Study Overview
Status
Completed
Conditions
Detailed Description
Able bodied participants will be used to simulate caregivers and wheelchair occupants.
Participants simulating caregivers will be asked to move the occupied wheelchair over a 5 m soft surface.
Participants will be randomly assigned a direction to move the wheelchair (forward or backwards), wheelchair occupant body position (upright or leaning forward) and technique in moving the wheelchair (upright with all 4 wheels on ground or in a wheelie position with the wheelchair tipped backwards and balanced on the rear wheels).
The ease of getting the occupied wheelchair over the soft surface will be evaluated by the amount of time taken to complete the task, how well the participant completed the task and the ease of performing the task as evaluated by the participant.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- able to communicate in English,
- alert, cooperative, and competent to provide informed consent,
- willing to participate (as evidenced by attending the single data-collection session), and
- have no physical impairments that would prevent their being able to push and pull a wheelchair over a soft surface
Exclusion Criteria:
- have unstable medical conditions that might make the handling of a manual wheelchair dangerous, or emotional problems that might make participation unsafe or unpleasant.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Upright wheelchair forward and occupant upright
Participant will push an upright wheelchair forward over a 5 m soft surface with the wheelchair occupant in the upright body position.
The participant will perform the task once.
|
Participants will move the wheelchair over 5 meters of a soft surface (gym mats) in the forward direction.
Participants will push the wheelchair when moving forward.
Participants will move the wheelchair across the 5 m soft surface using the upright technique.
The upright technique involves the wheelchair being moved with all 4 wheels on the ground.
The participant occupying the wheelchair (wheelchair occupant) will be seated with a body position that is upright (back is leaning against the wheelchair back rest and arms on wheelchair arm rests) while the wheelchair is being moved.
|
|
Experimental: Upright wheelchair backward and occupant upright
Participant will pull an upright wheelchair backwards over a 5 m soft surface with the wheelchair occupant in the upright body position.
The participant will perform the task once.
|
Participants will move the wheelchair across the 5 m soft surface using the upright technique.
The upright technique involves the wheelchair being moved with all 4 wheels on the ground.
The participant occupying the wheelchair (wheelchair occupant) will be seated with a body position that is upright (back is leaning against the wheelchair back rest and arms on wheelchair arm rests) while the wheelchair is being moved.
Participants will move the wheelchair over 5 meters of a soft surface (gym mats) in the backward direction.
Participants will pull the wheelchair when moving backwards.
|
|
Experimental: Wheelie wheelchair forward and occupant upright
Participant will push a wheelchair using the wheelie technique forward over a 5 m soft surface with the wheelchair occupant in the upright body position.The participant will perform the task once.
|
Participants will move the wheelchair over 5 meters of a soft surface (gym mats) in the forward direction.
Participants will push the wheelchair when moving forward.
The participant occupying the wheelchair (wheelchair occupant) will be seated with a body position that is upright (back is leaning against the wheelchair back rest and arms on wheelchair arm rests) while the wheelchair is being moved.
Participants will move the wheelchair across the 5 m soft surface using the wheelie technique.
The wheelie technique involves the wheelchair being tipped backward and balanced on the rear wheels.
Participant wheelchair occupants will always be upright when being moved using the wheelie technique.
|
|
Experimental: Wheelie wheelchair backward and occupant upright
Participant will pull a wheelchair using the wheelie technique backwards over a 5 m soft surface with the wheelchair occupant in the upright body position.The participant will perform the task once.
|
The participant occupying the wheelchair (wheelchair occupant) will be seated with a body position that is upright (back is leaning against the wheelchair back rest and arms on wheelchair arm rests) while the wheelchair is being moved.
Participants will move the wheelchair over 5 meters of a soft surface (gym mats) in the backward direction.
Participants will pull the wheelchair when moving backwards.
Participants will move the wheelchair across the 5 m soft surface using the wheelie technique.
The wheelie technique involves the wheelchair being tipped backward and balanced on the rear wheels.
Participant wheelchair occupants will always be upright when being moved using the wheelie technique.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time taken to perform task
Time Frame: through study completion , an average of 1 hour
|
The amount of time in seconds taken to perform the task and move the occupied wheelchair across 5 meters of soft surface (gym mats).
|
through study completion , an average of 1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ability to perform task
Time Frame: through study completion , an average of 1 hour
|
The ability of the participant to perform the task of moving the occupied wheelchair across the 5 meter soft surface.
Participant will be scored using an ordinal scale from 0 to 3 (0 = fail, distance completed < 2.5 m and /or time taken more than 20 seconds, 1=partial pass with distance completed between 2.5 m and 4.9 m and time less than or equal to 20 seconds, 2 = pass with completion of the 5 m distance and time taken between 11 and 20 seconds, and advanced pass = 3 with completion of the 5 m distance and time taken being less than or equal to 10 seconds).
|
through study completion , an average of 1 hour
|
|
Ease of performing the task
Time Frame: through study completion , an average of 1 hour
|
Participant self-reported ease of performing the task of moving the occupied wheelchair over a 5 meter soft surface.
A five-point Likert scale with 4 = "very easy", 3 = "somewhat easy", 2 = "neither easy nor difficult", 1 = "somewhat difficult" and 0 = "very difficult".
|
through study completion , an average of 1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2021
Primary Completion (Actual)
March 1, 2022
Study Completion (Actual)
September 1, 2022
Study Registration Dates
First Submitted
July 16, 2021
First Submitted That Met QC Criteria
August 3, 2021
First Posted (Actual)
August 10, 2021
Study Record Updates
Last Update Posted (Actual)
September 22, 2022
Last Update Submitted That Met QC Criteria
September 21, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- WSP-2021PP
- 1027105 (Other Identifier: Nova Scotia Health REB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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