<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/NCT02972307</url>
  </required_header>
  <id_info>
    <org_study_id>1020645</org_study_id>
    <nct_id>NCT02972307</nct_id>
  </id_info>
  <brief_title>Caregiver-aided Powered Wheelchair Skills</brief_title>
  <official_title>The Extent to Which Caregivers Enhance the Wheelchair Skills of Powered Wheelchair Users: a Descriptive Cross-sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nova Scotia Health Authority</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nova Scotia Health Authority</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There has been only minimal research on wheelchair skills by the caregivers of manual or&#xD;
      powered wheelchair. There are no published data on the extent to which caregivers can enhance&#xD;
      the mobility of powered wheelchair users. The primary objective of this study is to test the&#xD;
      hypothesis that caregivers enhance the wheelchair skills capacity, confidence and performance&#xD;
      of the powered wheelchair users to whom they provide assistance. Our secondary objective is&#xD;
      to add to the literature on the measurement properties of the wheelchair skills test&#xD;
      (questionnaire and capability version) for powered wheelchair users and their caregivers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Wheelchair Skills Test (WST)</measure>
    <time_frame>one day</time_frame>
    <description>Objective (WST) and Questionnaire (WST-Q) versions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Questionnaire</measure>
    <time_frame>one day</time_frame>
    <description>Qualitative open ended questions on wheelchair skills</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">152</enrollment>
  <condition>Caregivers</condition>
  <arm_group>
    <arm_group_label>caregiver</arm_group_label>
    <description>dyad of caregiver and the wheelchair user to whom they provide care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>wheelchair skills</intervention_name>
    <description>the extent to which caregivers enhance the wheelchair skills of powered wheelchair users</description>
    <arm_group_label>caregiver</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        dyads of caregivers and the wheelchair users to whom they provide care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years of age&#xD;
&#xD;
          -  able to communicate in English and/or French (depending upon the site)&#xD;
&#xD;
          -  live within 50 km of the research centre&#xD;
&#xD;
          -  be willing to participate (as evidenced by completion of the assessment)&#xD;
&#xD;
          -  be able to set a scheduled time for the study visit when both the caregiver and&#xD;
             wheelchair user will be present and provide informed consent&#xD;
&#xD;
        Caregivers:&#xD;
&#xD;
          -  must be an unpaid caregiver (e.g. a family member or friend)&#xD;
&#xD;
          -  spend an average total of at least 2 hours per week with the powered wheelchair user&#xD;
             that includes powered wheelchair mobility.&#xD;
&#xD;
        Wheelchair user:&#xD;
&#xD;
          -  must have his/her own powered wheelchair&#xD;
&#xD;
          -  use the powered wheelchair for at least 6 hours per week&#xD;
&#xD;
          -  have a caregiver who spends an average total of at least 2 hours per week with the&#xD;
             powered wheelchair user that includes powered wheelchair mobility.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have unstable medical conditions (e.g. angina, seizures) that might make the use of a&#xD;
             powered wheelchair dangerous&#xD;
&#xD;
          -  emotional problems (e.g. severe anxiety, depression) that might make participation&#xD;
             unsafe or unpleasant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lee Kirby, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dalhousie University, Nova Scotia Health Authority</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nova Scotia Rehabilitation Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 4K4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>January 10, 2018</last_update_submitted>
  <last_update_submitted_qc>January 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nova Scotia Health Authority</investigator_affiliation>
    <investigator_full_name>Lee Kirby</investigator_full_name>
    <investigator_title>Physician</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT02972307
org study id: 1020645
nct id: NCT02972307
lead sponsor: 
collaborator: 
has dmc: No
There has been only minimal research on wheelchair skills by the caregivers of manual or
      powered wheelchair. There are no published data on the extent to which caregivers can enhance
      the mobility of powered wheelchair users. The primary objective of this study is to test the
      hypothesis that caregivers enhance the wheelchair skills capacity, confidence and performance
      of the powered wheelchair users to whom they provide assistance. Our secondary objective is
      to add to the literature on the measurement properties of the wheelchair skills test
      (questionnaire and capability version) for powered wheelchair users and their caregivers.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Wheelchair Skills Test (WST)
time frame: one day
description: Objective (WST) and Questionnaire (WST-Q) versions
measure: Questionnaire
time frame: one day
description: Qualitative open ended questions on wheelchair skills
arm group label: caregiver
description: dyad of caregiver and the wheelchair user to whom they provide care
intervention type: Other
intervention name: wheelchair skills
description: the extent to which caregivers enhance the wheelchair skills of powered wheelchair users
arm group label: caregiver
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lee Kirby, MD, FRCPC
role: Principal Investigator
affiliation: Dalhousie University, Nova Scotia Health Authority
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Nova Scotia Health Authority
investigator full name: Lee Kirby
investigator title: Physician
sharing ipd: Undecided