<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03759769</url>
  </required_header>
  <id_info>
    <org_study_id>275323</org_study_id>
    <nct_id>NCT03759769</nct_id>
  </id_info>
  <brief_title>The McGill Wheelchair Simulator</brief_title>
  <acronym>miWe</acronym>
  <official_title>The McGill Immersive Wheelchair (miWe) Simulator for the Clinical Assessment and At-home Training of Powered Wheelchair Driving Skills</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGill University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>McGill University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effectiveness of a wheelchair simulator in the training of power&#xD;
      wheelchair driving skills. Practice with the simulator takes place at home.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mobility impairment is a major form of disability affecting Canadians of all ages. In Canada,&#xD;
      an estimated 0.6% of the general population need a wheelchair for mobility, while 20-30% of&#xD;
      these require a powered wheelchair (PW). Powered mobility is instrumental in facilitating&#xD;
      independence, promoting participation in meaningful life activities, and in decreasing the&#xD;
      burden on caregivers. Recovering mobility through the use of a PW may result in improvements&#xD;
      at the level of work, leisure and self-care. But because of their weight and speed, training&#xD;
      is required, as for any other vehicle. Further, PWs have an inherent risk of causing injuries&#xD;
      to the user or to bystanders, as well as damage to the environment. Therefore, assessment and&#xD;
      training are critical, so that participants may learn how to safely and efficiently handle&#xD;
      their PW, e.g., to avoid tips and falls, for maneuvering in tight spaces and to avoid&#xD;
      collisions with furniture or bystanders. However, assessment and training in navigating&#xD;
      crowded spaces or in complex route finding are often difficult to achieve in the clinic, due&#xD;
      to lack of space or concerns for safety. There is no standardized training process and in&#xD;
      practice, there is often little time for training during the PW delivery process. Further,&#xD;
      both clinicians and PW users agree that the amount of training provided to new PW drivers is&#xD;
      insufficient. To address these issues, team members have initiated work related to the&#xD;
      development of McGill Immersive Wheelchair (miWe) simulator version 1.0. This computer&#xD;
      software can be run in the clinic or at home, and has the potential to provide a robust&#xD;
      platform for the assessment and training of complex PW driving skills.&#xD;
&#xD;
      The objectives are: 1) to identify power wheelchair tasks that are challenging and/or unsafe&#xD;
      and are likely to be encountered by power wheelchair users. Phase 2) To create simulator maps&#xD;
      representing the tasks determined to be most challenging to users as per Phase 1. 3a) To&#xD;
      evaluate, in new PW users, the feasibility and acceptability of power wheelchair training&#xD;
      offered in a home-based simulator program that incorporates challenging tasks developed in&#xD;
      Phase 2. 3b) To determine the preliminary comparative effectiveness of power wheelchair&#xD;
      training using conventional training + a home-based simulator program VERSUS conventional&#xD;
      training + home-based joystick and visuo-spatial training program on: driving skills&#xD;
      (technical knowledge about wheelchair maneuvering and completion of driving tasks); driving&#xD;
      performance (how the task is performed); and driving confidence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2013</start_date>
  <completion_date type="Actual">May 30, 2016</completion_date>
  <primary_completion_date type="Actual">May 30, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in Wheelchair Skills Test (WST)</measure>
    <time_frame>2 weeks</time_frame>
    <description>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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in wheelchair confidence (WheelCon)</measure>
    <time_frame>2 weeks</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in appreciation of assistive technology (ATOP/M)</measure>
    <time_frame>2 weeks</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in life-space mobility (LSA)</measure>
    <time_frame>2 weeks</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Wheelchair (Powered) Colliding With Stationary Object</condition>
  <arm_group>
    <arm_group_label>simulator</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Practice at home all activities of the wheelchair simulator, at least 20 minute per session, at least one session every second day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Practice on a computer video game, at least 20 minute per session, at least one session every second day</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Wheelchair simulator</intervention_name>
    <description>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</description>
    <arm_group_label>simulator</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Video game</intervention_name>
    <description>'Kart' driving video game</description>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1) participants are between 18 and 65 years of age; 2) have received their first PW&#xD;
             within the last 3 months; 3) are living at home or in a long-term care facility (i.e.,&#xD;
             not currently hospitalized); 4) drive their PW with a hand-controlled joystick; 5) are&#xD;
             able to follow directions in either French or English as determined by their medical&#xD;
             chart from the rehabilitation center; 6) have no significant visual impairments not&#xD;
             corrected by eyewear; and 7) show sufficient cognition to participate in training&#xD;
             (Mini-mental State Exam&gt;25).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1) participants have baseline WST score greater than 85; 2) they have unstable medical&#xD;
             conditions as determined by their medical chart (e.g. angina, seizures that may be&#xD;
             exacerbated by the simulator)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philippe Archambault, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McGill University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jewish Rehabilitation Hospital</name>
      <address>
        <city>Laval</city>
        <state>Quebec</state>
        <zip>H7V1R2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McGill University</investigator_affiliation>
    <investigator_full_name>Philippe Archambault</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>power wheelchair</keyword>
  <keyword>virtual reality</keyword>
  <keyword>skills</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will not be shared with other researchers.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03759769
org study id: 275323
nct id: NCT03759769
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: change in Wheelchair Skills Test (WST)
time frame: 2 weeks
description: 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)
measure: change in wheelchair confidence (WheelCon)
time frame: 2 weeks
description: 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)
measure: change in appreciation of assistive technology (ATOP/M)
time frame: 2 weeks
description: 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).
measure: change in life-space mobility (LSA)
time frame: 2 weeks
description: 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).
arm group label: simulator
arm group type: Experimental
description: Practice at home all activities of the wheelchair simulator, at least 20 minute per session, at least one session every second day
arm group label: control
arm group type: Active Comparator
description: Practice on a computer video game, at least 20 minute per session, at least one session every second day
intervention type: Other
intervention name: Wheelchair simulator
description: 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
arm group label: simulator
intervention type: Other
intervention name: Video game
description: 'Kart' driving video game
arm group label: control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Philippe Archambault, PhD
role: Principal Investigator
affiliation: McGill University
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McGill University
investigator full name: Philippe Archambault
investigator title: Associate Professor
sharing ipd: No
ipd description: IPD will not be shared with other researchers.