<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/NCT02982252</url>
  </required_header>
  <id_info>
    <org_study_id>H14-01702 (Phase 2)</org_study_id>
    <nct_id>NCT02982252</nct_id>
  </id_info>
  <brief_title>Collaborative Power Mobility Innovative Learning OpporTunity (CoPILOT) - A Pilot Study of a New Training Approach (Phase 2)</brief_title>
  <official_title>Collaborative Power Mobility Innovative Learning OpporTunity (CoPILOT) - A Pilot Study of a New Training Approach (Phase 2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Networks of Centres of Excellence of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Alzheimer Society of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Promobilia Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rick Hansen Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Losing the ability to walk can lead to fewer opportunities to socialize with friends and&#xD;
      family and participate in the community. When this happens, powered wheelchairs can provide&#xD;
      access to homes and communities, contributing to health and well-being. Training by a&#xD;
      qualified occupational therapist allows an individual to use a powered wheelchair safely and&#xD;
      effectively. Learning to drive a powered wheelchair can be difficult, frustrating and time&#xD;
      consuming for people with cognitive and physical challenges. In this study, the investigators&#xD;
      will ask participants with cognitive impairments to complete training with an occupational&#xD;
      therapist using either a shared control wheelchair or training methods according to the&#xD;
      standard of care. The investigators believe shared control training, entitled Collaborative&#xD;
      Powered mobility Innovative Learning OpporTunity (CoPILOT) will enhance driving skill while&#xD;
      maximizing safety learning. CoPILOT has the potential to enable people to participate more in&#xD;
      their day to day lives and regain mobility independence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Powered wheelchairs can improve participation in daily life, increase quality of&#xD;
      life, and add 'life to years' for individuals with SCI. Cognitive limitations, associated&#xD;
      with advanced age at the time of a spinal cord injury or comorbid traumatic brain injury,&#xD;
      impair learning and may prevent an individual from acquiring or maintaining skills necessary&#xD;
      to drive a powered mobility device. Standard power wheelchair training, limited by time,&#xD;
      equipment and budget constraints, may not meet the learning needs of individuals with&#xD;
      cognitive impairment, preventing an individual from obtaining use of a powered wheelchair,&#xD;
      impacting independence and quality of life. The total system cost of procuring a power&#xD;
      wheelchair can range from $10,000 - $30,000; suboptimal use resulting from inadequate&#xD;
      training is a poor use of resources and comes at a substantial social price. The&#xD;
      Collaborative Power mobility Innovative Learning OpporTunity (CoPILOT) is a training approach&#xD;
      utilizing shared control wheelchair technology and allows a therapist to provide an&#xD;
      error-free learning experience for individuals in their own environments, while maintaining&#xD;
      safety of the user and the individuals around them. Using shared control technology, the&#xD;
      wheelchair user remains in control of the wheelchair while learning to drive, except in cases&#xD;
      where the trainer overrides the control (using a remote controlled interface) to maintain&#xD;
      safety and provide targeted learning opportunities.&#xD;
&#xD;
      Purpose and Objectives: The purpose of this study is to obtain pilot data for a larger&#xD;
      randomized control trial of a shared control power wheelchair training program (CoPILOT) for&#xD;
      improving power wheelchair mobility skills among novice power wheelchair users with comorbid&#xD;
      cognitive impairment compared to standard of care. Collection of pilot data is necessary&#xD;
      prior to moving forward with a larger randomized controlled trial (RCT).&#xD;
&#xD;
      Hypotheses: The investigators expect the intervention protocol will be feasible for a larger&#xD;
      randomized control trial. Compared to the standard of care group, the investigators expect&#xD;
      the CoPILOT group will experience significant improvement in power wheelchair skill capacity.&#xD;
      The investigators also expect the CoPILOT group will experience improvements in wheelchair&#xD;
      skill safety, confidence, capacity for divided attention tasks, and health related quality of&#xD;
      life, compared to the standard of care participants.&#xD;
&#xD;
      Methods: This feasibility study will use an evaluator blind parallel RCT. New power&#xD;
      wheelchair users with mild to moderate cognitive impairment will be recruited from the GF&#xD;
      Strong or Vancouver General Hospital Spinal Cord Injury patient population. Participants will&#xD;
      be randomly assigned to a CoPILOT (shared control training) group or standard of care group.&#xD;
      All training will be completed by qualified occupational therapist trainers. Participants in&#xD;
      both groups will receive either 6 or 12 hours of training in a standard powered wheelchair;&#xD;
      however, the CoPILOT groups will use remote control technology the investigators have&#xD;
      developed. Post-Treatment Qualitative Interviews will be conducted. Questions will be related&#xD;
      to protocol administration and use of the CoPILOT approach and shared control technology,&#xD;
      including necessary modifications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">October 1, 2019</completion_date>
  <primary_completion_date type="Actual">October 1, 2019</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 Power-mobility Indoor Driving Assessment (PIDA)</measure>
    <time_frame>Baseline (pre-randomization), Up to 5 Weeks (immediate post-intervention)</time_frame>
    <description>The PIDA covers specific tasks required for functional indoor driving, which are specific to the environment (i.e. accessing the bed from the right and left, and approaching the closet and dresser in the bedroom). The PIDA has been evaluated for content and face validity, has good inter-rater (ICC 0.87) and fair intra-rater (ICC 0.67) reliability.55. We aim to explore the potential usefulness of this outcome measure for this population, in this environment, for inclusion in future clinical trials.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Wheelchair Skills Test Questionnaire (WST-P-Q)</measure>
    <time_frame>Baseline (pre-randomization), Up to 5 weeks (immediate post-intervention)</time_frame>
    <description>The WST-P-Q is a standardized subjective evaluation of the capacity, performance, and confidence for 30 powered wheelchair skills. Total percent scores (0-100%) are calculated for both capacity, performance, and confidence. The WST was selected as a secondary measure because it is a standardized tool for evaluating wheelchair capacity, the primary construct of interest.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Wheelchair-use Confidence Scale (WheelCon-P )</measure>
    <time_frame>Baseline (pre-randomization), Up to 5 Weeks (immediate post-intervention)</time_frame>
    <description>This measurement for power wheelchair users is a 59-item self-report scale (0-100) with documented reliability and validity. Responses indicate current level of perceived confidence (%) to navigate the physical environment in a wheelchair, perform activities in a wheelchair, problem solve, advocate for specific needs, and manage social situations and emotions. The WheelCon was selected as a secondary outcome measure because confidence for using a wheelchair has been shown to influence wheelchair skills capacity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Health Utility Index Mark 3 (HUI3)</measure>
    <time_frame>Baseline (pre-randomization), Up to 5 Weeks (immediate post-intervention)</time_frame>
    <description>Health utility measurement is useful in performing cost-utility and cost-effectiveness analyses of new rehabilitation interventions. The HUI3 is a brief questionnaire that asks subjects about their health status, reflected in a single-score measure of health-related quality of life (HRQOL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in The Wheelchair Outcome Measure (WhOM)</measure>
    <time_frame>Baseline (pre-randomization), Up to 5 Weeks (immediate post-intervention)</time_frame>
    <description>The WhOM assess the individual's wheelchair related goals, the importance of those goals, and the satisfaction in their ability to complete those tasks. This will be used to assess goal attainment (performance and satisfaction) following training.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Wheeling While Talking Test</measure>
    <time_frame>Baseline (pre-randomization), Up to 5 Weeks (immediate post-intervention)</time_frame>
    <description>The Wheeling While Talking Test assesses the individual's ability to complete wheeling tasks under divided attention conditions. This test is being evaluated for use in powered wheelchair studies.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>CoPILOT (6 weeks)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental group participants will receive structured training in a standard powered wheelchair using the CoPILOT shared control wheelchair technology consisting of 6 hours total training time (1 hour training sessions, 3 days per week for 2 weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care (6 weeks)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of care participants will receive training according to the standard of care in rehabilitation facilities in the Vancouver area in a standard powered wheelchair consisting of 6 hours total training time (1 hour training sessions, 3 days per week for 2 weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CoPILOT (12 weeks)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental group participants will receive structured training in a standard powered wheelchair using the CoPILOT shared control wheelchair technology consisting of 12 hours total training time (1 hour training sessions, 4 days per week for 3 weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care (12 weeks)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of care participants will receive training according to the standard of care in rehabilitation facilities in the Vancouver area in a standard powered wheelchair consisting of 12 hours total training time (1 hour training sessions, 4 days per week for 3 weeks).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CoPILOT</intervention_name>
    <description>Participants in all groups will receive either six or twelve hours of training in a standard powered wheelchair; however, the CoPILOT groups will use remote control technology we have developed. The technology provides the trainer with remote control of wheelchair speed and direction allowing the trainer to override the participant's actions as needed to ensure safe error-free shared controlled wheelchair training. The CoPILOT approach will accommodate varied learning needs, as per adult learning principles, while decreasing trainer input until the participant can complete tasks independently.</description>
    <arm_group_label>CoPILOT (12 weeks)</arm_group_label>
    <arm_group_label>CoPILOT (6 weeks)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Live in a residential facility&#xD;
&#xD;
          2. Have mild to moderate cognitive impairment (MMSE 18-26)&#xD;
&#xD;
          3. Be new to powered wheelchairs (no full time driving experience for 3 weeks or more&#xD;
             within the past five years) or previously denied a powered wheelchair (due to&#xD;
             cognitive impairments impacting ability to learn or inability to learn the required&#xD;
             skills); and&#xD;
&#xD;
          4. Be physically able to operate a powered wheelchair joystick.&#xD;
&#xD;
        Exclusion Critera:&#xD;
&#xD;
          1. Have a visual or hearing impairment which may compromise training safety&#xD;
&#xD;
          2. Do not understand English well enough to complete assessments and/or training.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William C Miller, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GF Strong Rehabilitation Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 2G9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>November 1, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>October 7, 2019</last_update_submitted>
  <last_update_submitted_qc>October 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>William C. Miller</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Power mobility</keyword>
  <keyword>Wheelchair skills training</keyword>
  <keyword>Older adults</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <!-- 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/NCT02982252
org study id: H14-01702 (Phase 2)
nct id: NCT02982252
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Losing the ability to walk can lead to fewer opportunities to socialize with friends and
      family and participate in the community. When this happens, powered wheelchairs can provide
      access to homes and communities, contributing to health and well-being. Training by a
      qualified occupational therapist allows an individual to use a powered wheelchair safely and
      effectively. Learning to drive a powered wheelchair can be difficult, frustrating and time
      consuming for people with cognitive and physical challenges. In this study, the investigators
      will ask participants with cognitive impairments to complete training with an occupational
      therapist using either a shared control wheelchair or training methods according to the
      standard of care. The investigators believe shared control training, entitled Collaborative
      Powered mobility Innovative Learning OpporTunity (CoPILOT) will enhance driving skill while
      maximizing safety learning. CoPILOT has the potential to enable people to participate more in
      their day to day lives and regain mobility independence.
Background: Powered wheelchairs can improve participation in daily life, increase quality of
      life, and add 'life to years' for individuals with SCI. Cognitive limitations, associated
      with advanced age at the time of a spinal cord injury or comorbid traumatic brain injury,
      impair learning and may prevent an individual from acquiring or maintaining skills necessary
      to drive a powered mobility device. Standard power wheelchair training, limited by time,
      equipment and budget constraints, may not meet the learning needs of individuals with
      cognitive impairment, preventing an individual from obtaining use of a powered wheelchair,
      impacting independence and quality of life. The total system cost of procuring a power
      wheelchair can range from $10,000 - $30,000; suboptimal use resulting from inadequate
      training is a poor use of resources and comes at a substantial social price. The
      Collaborative Power mobility Innovative Learning OpporTunity (CoPILOT) is a training approach
      utilizing shared control wheelchair technology and allows a therapist to provide an
      error-free learning experience for individuals in their own environments, while maintaining
      safety of the user and the individuals around them. Using shared control technology, the
      wheelchair user remains in control of the wheelchair while learning to drive, except in cases
      where the trainer overrides the control (using a remote controlled interface) to maintain
      safety and provide targeted learning opportunities.

      Purpose and Objectives: The purpose of this study is to obtain pilot data for a larger
      randomized control trial of a shared control power wheelchair training program (CoPILOT) for
      improving power wheelchair mobility skills among novice power wheelchair users with comorbid
      cognitive impairment compared to standard of care. Collection of pilot data is necessary
      prior to moving forward with a larger randomized controlled trial (RCT).

      Hypotheses: The investigators expect the intervention protocol will be feasible for a larger
      randomized control trial. Compared to the standard of care group, the investigators expect
      the CoPILOT group will experience significant improvement in power wheelchair skill capacity.
      The investigators also expect the CoPILOT group will experience improvements in wheelchair
      skill safety, confidence, capacity for divided attention tasks, and health related quality of
      life, compared to the standard of care participants.

      Methods: This feasibility study will use an evaluator blind parallel RCT. New power
      wheelchair users with mild to moderate cognitive impairment will be recruited from the GF
      Strong or Vancouver General Hospital Spinal Cord Injury patient population. Participants will
      be randomly assigned to a CoPILOT (shared control training) group or standard of care group.
      All training will be completed by qualified occupational therapist trainers. Participants in
      both groups will receive either 6 or 12 hours of training in a standard powered wheelchair;
      however, the CoPILOT groups will use remote control technology the investigators have
      developed. Post-Treatment Qualitative Interviews will be conducted. Questions will be related
      to protocol administration and use of the CoPILOT approach and shared control technology,
      including necessary modifications.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Power-mobility Indoor Driving Assessment (PIDA)
time frame: Baseline (pre-randomization), Up to 5 Weeks (immediate post-intervention)
description: The PIDA covers specific tasks required for functional indoor driving, which are specific to the environment (i.e. accessing the bed from the right and left, and approaching the closet and dresser in the bedroom). The PIDA has been evaluated for content and face validity, has good inter-rater (ICC 0.87) and fair intra-rater (ICC 0.67) reliability.55. We aim to explore the potential usefulness of this outcome measure for this population, in this environment, for inclusion in future clinical trials.
measure: Change in Wheelchair Skills Test Questionnaire (WST-P-Q)
time frame: Baseline (pre-randomization), Up to 5 weeks (immediate post-intervention)
description: The WST-P-Q is a standardized subjective evaluation of the capacity, performance, and confidence for 30 powered wheelchair skills. Total percent scores (0-100%) are calculated for both capacity, performance, and confidence. The WST was selected as a secondary measure because it is a standardized tool for evaluating wheelchair capacity, the primary construct of interest.
measure: Change in Wheelchair-use Confidence Scale (WheelCon-P )
time frame: Baseline (pre-randomization), Up to 5 Weeks (immediate post-intervention)
description: This measurement for power wheelchair users is a 59-item self-report scale (0-100) with documented reliability and validity. Responses indicate current level of perceived confidence (%) to navigate the physical environment in a wheelchair, perform activities in a wheelchair, problem solve, advocate for specific needs, and manage social situations and emotions. The WheelCon was selected as a secondary outcome measure because confidence for using a wheelchair has been shown to influence wheelchair skills capacity.
measure: Change in Health Utility Index Mark 3 (HUI3)
time frame: Baseline (pre-randomization), Up to 5 Weeks (immediate post-intervention)
description: Health utility measurement is useful in performing cost-utility and cost-effectiveness analyses of new rehabilitation interventions. The HUI3 is a brief questionnaire that asks subjects about their health status, reflected in a single-score measure of health-related quality of life (HRQOL).
measure: Change in The Wheelchair Outcome Measure (WhOM)
time frame: Baseline (pre-randomization), Up to 5 Weeks (immediate post-intervention)
description: The WhOM assess the individual's wheelchair related goals, the importance of those goals, and the satisfaction in their ability to complete those tasks. This will be used to assess goal attainment (performance and satisfaction) following training.
measure: The Wheeling While Talking Test
time frame: Baseline (pre-randomization), Up to 5 Weeks (immediate post-intervention)
description: The Wheeling While Talking Test assesses the individual's ability to complete wheeling tasks under divided attention conditions. This test is being evaluated for use in powered wheelchair studies.
arm group label: CoPILOT (6 weeks)
arm group type: Experimental
description: Experimental group participants will receive structured training in a standard powered wheelchair using the CoPILOT shared control wheelchair technology consisting of 6 hours total training time (1 hour training sessions, 3 days per week for 2 weeks).
arm group label: Standard of Care (6 weeks)
arm group type: No Intervention
description: Standard of care participants will receive training according to the standard of care in rehabilitation facilities in the Vancouver area in a standard powered wheelchair consisting of 6 hours total training time (1 hour training sessions, 3 days per week for 2 weeks).
arm group label: CoPILOT (12 weeks)
arm group type: Experimental
description: Experimental group participants will receive structured training in a standard powered wheelchair using the CoPILOT shared control wheelchair technology consisting of 12 hours total training time (1 hour training sessions, 4 days per week for 3 weeks).
arm group label: Standard of Care (12 weeks)
arm group type: No Intervention
description: Standard of care participants will receive training according to the standard of care in rehabilitation facilities in the Vancouver area in a standard powered wheelchair consisting of 12 hours total training time (1 hour training sessions, 4 days per week for 3 weeks).
intervention type: Behavioral
intervention name: CoPILOT
description: Participants in all groups will receive either six or twelve hours of training in a standard powered wheelchair; however, the CoPILOT groups will use remote control technology we have developed. The technology provides the trainer with remote control of wheelchair speed and direction allowing the trainer to override the participant's actions as needed to ensure safe error-free shared controlled wheelchair training. The CoPILOT approach will accommodate varied learning needs, as per adult learning principles, while decreasing trainer input until the participant can complete tasks independently.
arm group label: CoPILOT (12 weeks)
arm group label: CoPILOT (6 weeks)
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: William C Miller, PhD
role: Principal Investigator
affiliation: University of British Columbia
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: William C. Miller
investigator title: Principal Investigator
mesh term: Cognitive Dysfunction