Wheelchair (Powered) Colliding With Stationary ObjectmiWeNCT03759769
The McGill Wheelchair Simulator
A study testing Wheelchair simulator and Video game in people with Wheelchair (Powered) Colliding With Stationary Object, run by McGill University at 1 site in Canada.
Trial summary
This study evaluates the effectiveness of a wheelchair simulator in the training of power wheelchair driving skills. Practice with the simulator takes place at home. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Wheelchair (Powered) Colliding With Stationary Object
- What is being tested?
- Wheelchair simulator and Video game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- 27 Nov 2013to 30 May 2016
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) participants are between 18 and 65 years of age; 2) have received their first PW within the last 3 months; 3) are living at home or in a long-term care facility (i.e., not currently hospitalized); 4) drive their PW with a hand-controlled joystick; 5) are able to follow directions in either French or English as determined by their medical chart from the rehabilitation center; 6) have no significant visual impairments not corrected by eyewear; and 7) show sufficient cognition to participate in training (Mini-mental State Exam>25).
Who cannot join
- 1) participants have baseline WST score greater than 85; 2) they have unstable medical conditions as determined by their medical chart (e.g. angina, seizures that may be exacerbated by the simulator)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The McGill Immersive Wheelchair (miWe) Simulator for the Clinical Assessment and At-home Training of Powered Wheelchair Driving Skills
This study evaluates the effectiveness of a wheelchair simulator in the training of power wheelchair driving skills. Practice with the simulator takes place at home.
Read the detailed description
Mobility impairment is a major form of disability affecting Canadians of all ages. In Canada, an estimated 0.6% of the general population need a wheelchair for mobility, while 20-30% of these require a powered wheelchair (PW). Powered mobility is instrumental in facilitating independence, promoting participation in meaningful life activities, and in decreasing the burden on caregivers. Recovering mobility through the use of a PW may result in improvements at the level of work, leisure and self-care. But because of their weight and speed, training is required, as for any other vehicle. Further, PWs have an inherent risk of causing injuries to the user or to bystanders, as well as damage to the environment. Therefore, assessment and training are critical, so that participants may learn how to safely and efficiently handle their PW, e.g., to avoid tips and falls, for maneuvering in tight spaces and to avoid collisions with furniture or bystanders. However, assessment and training in navigating crowded spaces or in complex route finding are often difficult to achieve in the clinic, due to lack of space or concerns for safety. There is no standardized training process and in practice, there is often little time for training during the PW delivery process. Further, both clinicians and PW users agree that the amount of training provided to new PW drivers is insufficient. To address these issues, team members have initiated work related to the development of McGill Immersive Wheelchair (miWe) simulator version 1.0. This computer software can be run in the clinic or at home, and has the potential to provide a robust platform for the assessment and training of complex PW driving skills.
The objectives are: 1) to identify power wheelchair tasks that are challenging and/or unsafe and are likely to be encountered by power wheelchair users. Phase 2) To create simulator maps representing the tasks determined to be most challenging to users as per Phase 1. 3a) To evaluate, in new PW users, the feasibility and acceptability of power wheelchair training offered in a home-based simulator program that incorporates challenging tasks developed in Phase 2. 3b) To determine the preliminary comparative effectiveness of power wheelchair training using conventional training + a home-based simulator program VERSUS conventional training + home-based joystick and visuo-spatial training program on: driving skills (technical knowledge about wheelchair maneuvering and completion of driving tasks); driving performance (how the task is performed); and driving confidence.
- Being tested
- Wheelchair simulator, Video game
- Keywords
- power wheelchair, virtual reality, skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheelchair simulatorOther
Computer application providing 3D first person view of a wheelchair, with six different activities: street crossing, entering an elevator, entering an adapted van, bathroom, shopping mall and supermarket
Video gameOther
'Kart' driving video game
| Study group | Role | What they receive |
|---|---|---|
| simulator | Experimental | Practice at home all activities of the wheelchair simulator, at least 20 minute per session, at least one session every second day Receives: Other: Wheelchair simulator |
| control | Active comparator | Practice on a computer video game, at least 20 minute per session, at least one session every second day Receives: Other: Video game |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Wheelchair Skills Test (WST)
Measures power wheelchair driving skills; 32 items scored using pass or fail. The average of valid items is computed and converted to percentage (range: 0-100 with higher values indicating better wheelchair skills)
Measured: 2 weeks
Secondary outcomes (3)
change in wheelchair confidence (WheelCon)
Measures driving confidence; 62 items in 6 categories, scored on 0 to 100. Average of valid items are computed for each sub scale; a total score is then computed by averaging the sub scales (range: 0-100; higher score indicates higher wheelchair confidence)
Measured: 2 weeks
change in appreciation of assistive technology (ATOP/M)
Assistive Technology Outcomes Profile for Mobility; measures subjective appreciation of assistive technology by comparing performance in activities with and without an assistive device. The scale includes 28 items scored from 1 to 5. Total score is the average, converted to percentile (range 0-100 with higher score indicating better appreciation of assistive device).
Measured: 2 weeks
change in life-space mobility (LSA)
Life-Space Assessment. The scale measures how frequently (never to every day) one spends time in different life spaces (home, around the home, neighborhood, city, other cities); and if one requires assistive devices or physical assistance. A score for each living area is computed by multiplying frequency of use (1 to 5) to independence (1 to 5), for a range of 1-25. A total score is computed by adding the sub scales (range: 5-125 with greater scores indicating higher use of life spaces and more independence).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start27 Nov 2013
- Primary completion30 May 2016
- Study completion30 May 2016
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 Wheelchair (Powered) Colliding With Stationary ObjectStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
- Responsible party
- Principal investigator, Philippe Archambault, McGill University
- Investigators
- Philippe Archambault, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759769
- Sponsor's protocol ID
- 275323
- Acronym
- miWe
- Status last verified
- Nov 2018
- First submitted
- 27 Nov 2018
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Publications
Faure C, Routhier F, Lettre J, Choukou MA, Archambault PS. Effectiveness of the miWe Simulator Training on Powered Wheelchair-driving Skills: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2023 Sep;104(9):1371-1377. doi: 10.1016/j.apmr.2023.04.022. Epub 2023 May 19.
PubMed 37209934
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The McGill Immersive Wheelchair (miWe) Simulator for the Clinical Assessment and At-home Training of Powered Wheelchair Driving Skills
- ClinicalTrials.gov ID
- NCT03759769
- Acronym / sponsor ID
- miWe / 275323
- Keywords
- power wheelchair, virtual reality, skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
- Study start
- 27 Nov 2013 (actual)
- Primary completion
- 30 May 2016 (actual)
- Study completion
- 30 May 2016 (actual)
- First posted
- 30 Nov 2018 (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.
This study evaluates the effectiveness of a wheelchair simulator in the training of power wheelchair driving skills. Practice with the simulator takes place at home.
Detailed description
Mobility impairment is a major form of disability affecting Canadians of all ages. In Canada, an estimated 0.6% of the general population need a wheelchair for mobility, while 20-30% of these require a powered wheelchair (PW). Powered mobility is instrumental in facilitating independence, promoting participation in meaningful life activities, and in decreasing the burden on caregivers. Recovering mobility through the use of a PW may result in improvements at the level of work, leisure and self-care. But because of their weight and speed, training is required, as for any other vehicle. Further, PWs have an inherent risk of causing injuries to the user or to bystanders, as well as damage to the environment. Therefore, assessment and training are critical, so that participants may learn how to safely and efficiently handle their PW, e.g., to avoid tips and falls, for maneuvering in tight spaces and to avoid collisions with furniture or bystanders. However, assessment and training in navigating crowded spaces or in complex route finding are often difficult to achieve in the clinic, due to lack of space or concerns for safety. There is no standardized training process and in practice, there is often little time for training during the PW delivery process. Further, both clinicians and PW users agree that the amount of training provided to new PW drivers is insufficient. To address these issues, team members have initiated work related to the development of McGill Immersive Wheelchair (miWe) simulator version 1.0. This computer software can be run in the clinic or at home, and has the potential to provide a robust platform for the assessment and training of complex PW driving skills.
The objectives are: 1) to identify power wheelchair tasks that are challenging and/or unsafe and are likely to be encountered by power wheelchair users. Phase 2) To create simulator maps representing the tasks determined to be most challenging to users as per Phase 1. 3a) To evaluate, in new PW users, the feasibility and acceptability of power wheelchair training offered in a home-based simulator program that incorporates challenging tasks developed in Phase 2. 3b) To determine the preliminary comparative effectiveness of power wheelchair training using conventional training + a home-based simulator program VERSUS conventional training + home-based joystick and visuo-spatial training program on: driving skills (technical knowledge about wheelchair maneuvering and completion of driving tasks); driving performance (how the task is performed); and driving confidence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| simulator | Experimental | Other: Wheelchair simulatorPractice at home all activities of the wheelchair simulator, at least 20 minute per session, at least one session every second day |
| control | Active comparator | Other: Video gamePractice on a computer video game, at least 20 minute per session, at least one session every second day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) participants are between 18 and 65 years of age; 2) have received their first PW within the last 3 months; 3) are living at home or in a long-term care facility (i.e., not currently hospitalized); 4) drive their PW with a hand-controlled joystick; 5) are able to follow directions in either French or English as determined by their medical chart from the rehabilitation center; 6) have no significant visual impairments not corrected by eyewear; and 7) show sufficient cognition to participate in training (Mini-mental State Exam>25).
Key exclusion criteria (1 listed)
- 1) participants have baseline WST score greater than 85; 2) they have unstable medical conditions as determined by their medical chart (e.g. angina, seizures that may be exacerbated by the simulator)
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 simulatorComputer application providing 3D first person view of a wheelchair, with six different activities: street crossing, entering an elevator, entering an adapted van, bathroom, shopping mall and supermarket | Other | simulator |
| Video game'Kart' driving video game | Other | control |
Primary outcome
change in Wheelchair Skills Test (WST)
Time frame: 2 weeks
Measures power wheelchair driving skills; 32 items scored using pass or fail. The average of valid items is computed and converted to percentage (range: 0-100 with higher values indicating better wheelchair skills)
3 secondary outcomes
change in wheelchair confidence (WheelCon)
Time frame: 2 weeks
change in appreciation of assistive technology (ATOP/M)
Time frame: 2 weeks
change in life-space mobility (LSA)
Time frame: 2 weeks
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 30 Nov 2018.
- Derived from this study: PubMed 37209934Faure C, Routhier F, Lettre J, Choukou MA, Archambault PS. Effectiveness of the miWe Simulator Training on Powered Wheelchair-driving Skills: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2023 Sep;104(9):1371-1377. doi: 10.1016/j.apmr.2023.04.022. Epub 2023 May 19.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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.
Philippe Archambault, PhD principal investigator
McGill University
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 simulator and Video game in people with Wheelchair (Powered) Colliding With Stationary Object, run by McGill University 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 1 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 30 Nov 2018. 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?
change in Wheelchair Skills Test (WST) (time frame: 2 weeks). 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 NCT03759769, 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 30 Nov 2018.