- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03759769
The McGill Wheelchair Simulator (miWe)
The McGill Immersive Wheelchair (miWe) Simulator for the Clinical Assessment and At-home Training of Powered Wheelchair Driving Skills
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Laval, Quebec, Canada, H7V1R2
- Jewish Rehabilitation Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: simulator
Practice at home all activities of the wheelchair simulator, at least 20 minute per session, at least one session every second day
|
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
|
|
Active Comparator: control
Practice on a computer video game, at least 20 minute per session, at least one session every second day
|
'Kart' driving video game
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in wheelchair confidence (WheelCon)
Time Frame: 2 weeks
|
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)
|
2 weeks
|
|
change in appreciation of assistive technology (ATOP/M)
Time Frame: 2 weeks
|
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).
|
2 weeks
|
|
change in life-space mobility (LSA)
Time Frame: 2 weeks
|
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).
|
2 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philippe Archambault, PhD, McGill University
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
Keywords
Other Study ID Numbers
- 275323
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Clinical Trials on Wheelchair simulator
-
VA Office of Research and DevelopmentCompletedSpinal Cord Injuries and DisordersUnited States
-
HaEmek Medical Center, IsraelCompletedFatigue | Back Pain | Personal SatisfactionIsrael
-
Guangzhou University of Traditional Chinese MedicineCompleted
-
Nova Scotia Health AuthorityDalhousie UniversityCompleted
-
Nova Scotia Health AuthoritySuspended
-
University of PrimorskaCompleted
-
Hospital Center Guillaume RégnierCompleted
-
University of PittsburghU.S. Department of EducationCompleted
-
Royal College of Surgeons, IrelandHealth Service ExecutiveUnknownTraining | Education | Computer SimulationIreland
-
Tianjin Medical University General HospitalRecruitingComputer Simulator and Mannequin SimulatorChina