Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-01-02 @ 7:22 AM
Study NCT ID:
NCT03759769
Status:
COMPLETED
Last Update Posted:
2018-11-30
First Post:
2018-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The McGill Wheelchair Simulator
Sponsor:
McGill University
Organization:
Study Overview
Official Title:
The McGill Immersive Wheelchair (miWe) Simulator for the Clinical Assessment and At-home Training of Powered Wheelchair Driving Skills
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
miWe
Brief 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: