<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/NCT03808428</url>
  </required_header>
  <id_info>
    <org_study_id>2018.493</org_study_id>
    <nct_id>NCT03808428</nct_id>
  </id_info>
  <brief_title>CUHK Jockey Club HOPE 4 Care Programme - Ankle Robot</brief_title>
  <official_title>CUHK Jockey Club Tech-Based Stroke Rehabilitation Programme for Elderly Centre - Interactive Exoskeleton Ankle Robot</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Hong Kong Jockey Club Charities Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese University of Hong Kong</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>
      The Hong Kong Jockey Club Charities Trust has supported CUHK to launch a three-year project&#xD;
      'CUHK Jockey Club HOPE4Care Programme' to implement four evidence-based advanced&#xD;
      rehabilitation technologies in 40 local elderly day care centres and rehabilitation centres,&#xD;
      to benefit the community. The Exoskeleton Ankle Robot is a robot-assisted Ankle-Foot-Orthosis&#xD;
      to facilitate gait training of person after stroke with drop foot.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment Lower Extremity (FMA-LE)</measure>
    <time_frame>3-month follow-up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional Ambulation Classification (FAC)</measure>
    <time_frame>3-month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Ashworth Scale (MAS)</measure>
    <time_frame>3-month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Scale (BBS)</measure>
    <time_frame>3-month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed 10-Meter Walk Test (10MWT)</measure>
    <time_frame>3-month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 Minute Walk Test (6MWT)</measure>
    <time_frame>3-month follow-up</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Ankle Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Integrated with force and motion sensors to identify gait phase and classify user walking intention using machine learning control algorithm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ankle Group</intervention_name>
    <description>Provide sensory feedback to help subjects relearn how to walk in correct gait pattern.</description>
    <arm_group_label>Ankle Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  have the ability to walk on the ground independently or with one personal assistance&#xD;
             with or without walking aids&#xD;
&#xD;
          -  able to understand simple commends&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have other neurological, neuromuscular, and orthopedic diseases&#xD;
&#xD;
          -  uncontrolled cardiovascular or respiratory disorders&#xD;
&#xD;
          -  moderate to severe contractures in the lower extremities&#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>Raymond Tong, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Biomedical Engineering, CUHK</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Raymond Tong, PhD</last_name>
    <phone>+85239438454</phone>
    <email>kytong@cuhk.edu.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Biomedical Engineering, The Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raymond Tong, PhD</last_name>
      <phone>+852 3943 8454</phone>
    </contact>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Raymond KY Tong</investigator_full_name>
    <investigator_title>Professor and Chairman</investigator_title>
  </responsible_party>
  <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/NCT03808428
org study id: 2018.493
nct id: NCT03808428
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Hong Kong Jockey Club Charities Trust has supported CUHK to launch a three-year project
      'CUHK Jockey Club HOPE4Care Programme' to implement four evidence-based advanced
      rehabilitation technologies in 40 local elderly day care centres and rehabilitation centres,
      to benefit the community. The Exoskeleton Ankle Robot is a robot-assisted Ankle-Foot-Orthosis
      to facilitate gait training of person after stroke with drop foot.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Fugl-Meyer Assessment Lower Extremity (FMA-LE)
time frame: 3-month follow-up
measure: Functional Ambulation Classification (FAC)
time frame: 3-month follow-up
measure: Modified Ashworth Scale (MAS)
time frame: 3-month follow-up
measure: Berg Balance Scale (BBS)
time frame: 3-month follow-up
measure: Timed 10-Meter Walk Test (10MWT)
time frame: 3-month follow-up
measure: 6 Minute Walk Test (6MWT)
time frame: 3-month follow-up
arm group label: Ankle Group
arm group type: Experimental
description: Integrated with force and motion sensors to identify gait phase and classify user walking intention using machine learning control algorithm.
intervention type: Device
intervention name: Ankle Group
description: Provide sensory feedback to help subjects relearn how to walk in correct gait pattern.
arm group label: Ankle Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Raymond Tong, PhD
role: Principal Investigator
affiliation: Department of Biomedical Engineering, CUHK
last name: Raymond Tong, PhD
phone: +85239438454
email: kytong@cuhk.edu.hk
facility: 
status: Recruiting
contact: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Raymond KY Tong
investigator title: Professor and Chairman
mesh term: Stroke
sharing ipd: No