<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/NCT02995265</url>
  </required_header>
  <id_info>
    <org_study_id>H15-01339</org_study_id>
    <nct_id>NCT02995265</nct_id>
  </id_info>
  <brief_title>Exoskeleton for Post-Stroke Recovery of Ambulation</brief_title>
  <acronym>ExStRA</acronym>
  <official_title>Use of a Robotic Exoskeleton to Promote Walking Recovery After Stroke - Phase 2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Heart and Stroke Foundation of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the effect of using a robotic exoskeleton to allow walking practice after&#xD;
      stroke, compared to usual physiotherapy care, on recovery of walking ability and secondary&#xD;
      outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants admitted to inpatient stroke rehabilitation for physiotherapy services will be&#xD;
      randomly assigned to either the Exoskeleton Program or Usual Care Program.&#xD;
&#xD;
      Individuals in the Exoskeleton Program will have their usual physiotherapy sessions replaced&#xD;
      with the exoskeleton intervention. The exoskeleton will allow standing and walking from the&#xD;
      first sessions in rehabilitation, as the exoskeleton provides the physical support to allow&#xD;
      walking in full weight-bearing without being limited by therapist fatigue and lifting&#xD;
      requirements. Individuals in the Usual Care Program will receive standard physiotherapy care,&#xD;
      which is individualized and hands-on with their therapist to regain walking, mobility, and&#xD;
      independent function.&#xD;
&#xD;
      Both groups will be conducted 3-5 days a week, 30-60 minutes per session until discharge (to&#xD;
      a maximum of 8 weeks). Participants will be assessed at baseline, discharge, and 6-months&#xD;
      after starting rehabilitation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">February 8, 2020</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>Walking ability - Functional Ambulation Category</measure>
    <time_frame>Rehabilitation Discharge (generally 4-6 weeks, up to 8 weeks)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>5-Metre Walk Test (5MWT)</measure>
    <time_frame>Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-Minute Walk Test (6MWT)</measure>
    <time_frame>Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Scale (BBS)</measure>
    <time_frame>Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related Quality of Life (SF-36)</measure>
    <time_frame>Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive Symptoms (PHQ-9)</measure>
    <time_frame>Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days to independent walking</measure>
    <time_frame>Discharge (generally 4-6 weeks, up to 8 weeks)</time_frame>
    <description>The number of days from admission until the participant is able to walk without any manual assistance from a therapist will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor impairment/recovery of the lower extremity (Fugl-Meyer Lower)</measure>
    <time_frame>Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognition - Montreal Cognitive Assessment (MoCA)</measure>
    <time_frame>Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Ambulation Category</measure>
    <time_frame>6 Months from admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily step count</measure>
    <time_frame>6 months from admission</time_frame>
    <description>ActivPAL recording over 4 days</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Conditions</condition>
  <arm_group>
    <arm_group_label>Exoskeleton Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exoskeleton-based walking rehabilitation until discharge (or to a maximum of 8 weeks), 3 - 5 days a week for 30-60 minutes per session. Participants will be assessed upon admission to the study, discharge, as well as at 6 months post-stroke. The exoskeleton will allow standing and walking with full weight bearing from the first sessions in rehabilitation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard physiotherapy stroke rehabilitation which includes training for regaining walking as well as other functional tasks, 3 - 5 days a week for 30-60 minutes per session until discharge (or to a maximum of 8 weeks). Participants will be assessed upon admission to the study, discharge, as well as at 6 months post-stroke.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Exoskeleton Program</intervention_name>
    <description>Subjects will wear the exoskeleton device at each physiotherapy session to work on improving mobility and walking ability.</description>
    <arm_group_label>Exoskeleton Program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care Program</intervention_name>
    <description>Subjects will receive hands-on physiotherapy to improve their mobility and walking ability. Physiotherapy session will be tailored to subject individually by their therapist.</description>
    <arm_group_label>Usual Care Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have been admitted to a hospital unit for stroke treatment&#xD;
&#xD;
          -  Stroke within last 3 months&#xD;
&#xD;
          -  One-sided hemiparesis&#xD;
&#xD;
          -  19 years or older&#xD;
&#xD;
          -  Requires 2-person assist to walk&#xD;
&#xD;
          -  Able to communicate and follow instructions&#xD;
&#xD;
          -  Prescribed to receive physiotherapy care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stroke of non-vascular origin (e.g. tumour, infection)&#xD;
&#xD;
          -  Significant musculoskeletal or other neurological condition&#xD;
&#xD;
          -  Co-morbidities that would preclude activity&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Unable to walk prior to stroke&#xD;
&#xD;
          -  &lt;60 inches or &gt;74 inches in height&#xD;
&#xD;
          -  &gt;220 pounds in weight&#xD;
&#xD;
          -  Joint contractures or spasticity that would limit safe use of the Ekso exoskeleton&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janice J Eng, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Physical Therapy, University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Glenrose Rehabilitation hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5B0b7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GF Strong Rehab Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 2G9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkwood Institute</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6C0A7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>August 27, 2020</last_update_submitted>
  <last_update_submitted_qc>August 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Janice Eng</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Exoskeleton</keyword>
  <keyword>Stroke</keyword>
  <keyword>Walking</keyword>
  <keyword>Rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02995265
org study id: H15-01339
nct id: NCT02995265
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
To determine the effect of using a robotic exoskeleton to allow walking practice after
      stroke, compared to usual physiotherapy care, on recovery of walking ability and secondary
      outcomes.
Participants admitted to inpatient stroke rehabilitation for physiotherapy services will be
      randomly assigned to either the Exoskeleton Program or Usual Care Program.

      Individuals in the Exoskeleton Program will have their usual physiotherapy sessions replaced
      with the exoskeleton intervention. The exoskeleton will allow standing and walking from the
      first sessions in rehabilitation, as the exoskeleton provides the physical support to allow
      walking in full weight-bearing without being limited by therapist fatigue and lifting
      requirements. Individuals in the Usual Care Program will receive standard physiotherapy care,
      which is individualized and hands-on with their therapist to regain walking, mobility, and
      independent function.

      Both groups will be conducted 3-5 days a week, 30-60 minutes per session until discharge (to
      a maximum of 8 weeks). Participants will be assessed at baseline, discharge, and 6-months
      after starting rehabilitation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Walking ability - Functional Ambulation Category
time frame: Rehabilitation Discharge (generally 4-6 weeks, up to 8 weeks)
measure: 5-Metre Walk Test (5MWT)
time frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
measure: 6-Minute Walk Test (6MWT)
time frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
measure: Berg Balance Scale (BBS)
time frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
measure: Health-related Quality of Life (SF-36)
time frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
measure: Depressive Symptoms (PHQ-9)
time frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
measure: Days to independent walking
time frame: Discharge (generally 4-6 weeks, up to 8 weeks)
description: The number of days from admission until the participant is able to walk without any manual assistance from a therapist will be recorded.
measure: Motor impairment/recovery of the lower extremity (Fugl-Meyer Lower)
time frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
measure: Cognition - Montreal Cognitive Assessment (MoCA)
time frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
measure: Functional Ambulation Category
time frame: 6 Months from admission
measure: Daily step count
time frame: 6 months from admission
description: ActivPAL recording over 4 days
arm group label: Exoskeleton Program
arm group type: Experimental
description: Exoskeleton-based walking rehabilitation until discharge (or to a maximum of 8 weeks), 3 - 5 days a week for 30-60 minutes per session. Participants will be assessed upon admission to the study, discharge, as well as at 6 months post-stroke. The exoskeleton will allow standing and walking with full weight bearing from the first sessions in rehabilitation.
arm group label: Usual Care Program
arm group type: Active Comparator
description: Standard physiotherapy stroke rehabilitation which includes training for regaining walking as well as other functional tasks, 3 - 5 days a week for 30-60 minutes per session until discharge (or to a maximum of 8 weeks). Participants will be assessed upon admission to the study, discharge, as well as at 6 months post-stroke.
intervention type: Device
intervention name: Exoskeleton Program
description: Subjects will wear the exoskeleton device at each physiotherapy session to work on improving mobility and walking ability.
arm group label: Exoskeleton Program
intervention type: Other
intervention name: Usual Care Program
description: Subjects will receive hands-on physiotherapy to improve their mobility and walking ability. Physiotherapy session will be tailored to subject individually by their therapist.
arm group label: Usual Care Program
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Janice J Eng, PhD
role: Principal Investigator
affiliation: Department of Physical Therapy, University of British Columbia
facility: 
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Janice Eng
investigator title: Principal Investigator
mesh term: Stroke
sharing ipd: No