The McGill Wheelchair Simulator (miWe)

November 28, 2018 updated by: Philippe Archambault, McGill University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • Quebec
      • Laval, Quebec, Canada, H7V1R2
        • Jewish Rehabilitation Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: simulator
Practice at home all activities of the wheelchair simulator, at least 20 minute per session, at least one session every second day
Other: Wheelchair simulator
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
Other: Video game
'Kart' driving video game

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McGill University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Philippe Archambault, PhD, McGill University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 275323

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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