WheelchairsNCT04998539
Effect of Travel Direction, Body Position and Technique on the Ease of Getting an Occupied Wheelchair Over a Soft Surface
A study testing Wheelchair forward direction, Wheelchair backward direction and Upright technique in people with Wheelchairs, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wheelchairs
- What is being tested?
- Wheelchair forward direction, Wheelchair backward direction and Upright technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2021to 1 Sep 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- have unstable medical conditions that might make the handling of a manual wheelchair dangerous, or emotional problems that might make participation unsafe or unpleasant.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Nova Scotia Rehabilitation and Arthritis Centre
Halifax, Nova Scotia, B3H 4K4
About this study
Official title: 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.
Read the 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.
- Conditions
- Wheelchairs
- Being tested
- Wheelchair forward direction, Wheelchair backward direction, Upright technique, Wheelie technique, Wheelchair occupant upright body position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheelchair forward directionOther
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.
Wheelchair backward directionOther
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.
Upright techniqueOther
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.
Wheelie techniqueOther
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.
Wheelchair occupant upright body positionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Upright wheelchair forward and occupant upright | Experimental | 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. Receives: Other: Wheelchair forward direction; Other: Upright technique; Other: Wheelchair occupant upright body position |
| Upright wheelchair backward and occupant upright | Experimental | 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. Receives: Other: Wheelchair backward direction; Other: Upright technique; Other: Wheelchair occupant upright body position |
| Wheelie wheelchair forward and occupant upright | Experimental | 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. Receives: Other: Wheelchair forward direction; Other: Wheelie technique; Other: Wheelchair occupant upright body position |
| Wheelie wheelchair backward and occupant upright | Experimental | 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. Receives: Other: Wheelchair backward direction; Other: Wheelie technique; Other: Wheelchair occupant upright body position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time taken to perform task
The amount of time in seconds taken to perform the task and move the occupied wheelchair across 5 meters of soft surface (gym mats).
Measured: through study completion , an average of 1 hour
Secondary outcomes (2)
Ability to perform task
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).
Measured: through study completion , an average of 1 hour
Ease of performing the task
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".
Measured: through study completion , an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start1 Aug 2021
- Primary completion1 Mar 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for WheelchairsStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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
- Randomised
- Intervention model
- Crossover
- Model description
- This study consists of a randomized crossover trial with within-participant comparisons.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University
- Responsible party
- Principal investigator, Lee Kirby, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998539
- Sponsor's protocol ID
- WSP-2021PP
- Other IDs
- 1027105
- Status last verified
- Sep 2022
- First submitted
- 16 Jul 2021
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kirby RL, Parker K, Poon E, Smith C, Osmond D, Ladouceur M, Haworth VS, Theriault CJ, Sandila N. Effect of travel direction and wheelchair position on the ease of a caregiver getting an occupied wheelchair across a soft surface: a randomized crossover trial. Disabil Rehabil Assist Technol. 2024 May;19(4):1298-1306. doi: 10.1080/17483107.2023.2170476. Epub 2023 Jan 25.
PubMed 36695416
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04998539
- Acronym / sponsor ID
- WSP-2021PP
- Conditions
- Wheelchairs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Dalhousie University
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 10 Aug 2021 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- This study consists of a randomized crossover trial with within-participant comparisons.
| Arm | Type | Receives |
|---|---|---|
| Upright wheelchair forward and occupant upright | Experimental | Other: Wheelchair forward direction, Other: Upright technique, Other: Wheelchair occupant upright body positionParticipant 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. |
| Upright wheelchair backward and occupant upright | Experimental | Other: Wheelchair backward direction, Other: Upright technique, Other: Wheelchair occupant upright body positionParticipant 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. |
| Wheelie wheelchair forward and occupant upright | Experimental | Other: Wheelchair forward direction, Other: Wheelie technique, Other: Wheelchair occupant upright body positionParticipant 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. |
| Wheelie wheelchair backward and occupant upright | Experimental | Other: Wheelchair backward direction, Other: Wheelie technique, Other: Wheelchair occupant upright body positionParticipant 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- have unstable medical conditions that might make the handling of a manual wheelchair dangerous, or emotional problems that might make participation unsafe or unpleasant.
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 |
|---|---|---|
| Wheelchair forward directionParticipants 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. | Other | Upright wheelchair forward and occupant upright, Wheelie wheelchair forward and occupant upright |
| Wheelchair backward directionParticipants 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. | Other | Upright wheelchair backward and occupant upright, Wheelie wheelchair backward and occupant upright |
| Upright techniqueParticipants 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. | Other | Upright wheelchair backward and occupant upright, Upright wheelchair forward and occupant upright |
| Wheelie techniqueParticipants 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. | Other | Wheelie wheelchair backward and occupant upright, Wheelie wheelchair forward and occupant upright |
| Wheelchair occupant upright body positionThe 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. | Other | Upright wheelchair backward and occupant upright, Upright wheelchair forward and occupant upright, Wheelie wheelchair backward and occupant upright, Wheelie wheelchair forward and occupant upright |
Primary outcome
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).
2 secondary outcomes
Ability to perform task
Time frame: through study completion , an average of 1 hour
Ease of performing the task
Time frame: through study completion , an average of 1 hour
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 22 Sep 2022.
- Derived from this study: PubMed 36695416Kirby RL, Parker K, Poon E, Smith C, Osmond D, Ladouceur M, Haworth VS, Theriault CJ, Sandila N. Effect of travel direction and wheelchair position on the ease of a caregiver getting an occupied wheelchair across a soft surface: a randomized crossover trial. Disabil Rehabil Assist Technol. 2024 May;19(4):1298-1306. doi: 10.1080/17483107.2023.2170476. Epub 2023 Jan 25.
Related trials for Wheelchairs
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Recruiting
Comparison Between Objective Biomechanical Cost and Perceived Physical Demand in Manual Wheelchair Users During Propulsion Tasks
Manual Wheelchair Use, Spinal Cord Injury
Not yet recruiting
Efficacy of Seated Physical Activity INtervention(SPIN) for Wheelchair Users With Multiple Sclerosis
Multiple Sclerosis
Not yet recruiting
Personal Exoskeleton or Manual Wheelchair: a Comparison of Performance and Satisfaction in Activities of Daily Living Among People With Spinal Cord Injuries, Using the SCED Methodology.
Paraplegia, Spinal Cord Injury
Not yet recruiting
User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems
Mobility Impairment
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 Wheelchair forward direction, Wheelchair backward direction and Upright technique in people with Wheelchairs, run by Nova Scotia Health Authority 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 4 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 22 Sep 2022. 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?
Time taken to perform task (time frame: through study completion , an average of 1 hour). 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 NCT04998539, which also lists 1 linked publication.
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 22 Sep 2022.