<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/NCT03808415</url>
  </required_header>
  <id_info>
    <org_study_id>2018.399</org_study_id>
    <nct_id>NCT03808415</nct_id>
  </id_info>
  <brief_title>CUHK Jockey Club HOPE 4 Care Programme - Hand of Hope</brief_title>
  <official_title>Jockey Club Tech-based Stroke Rehabilitation Programme - Hand of Hope</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.&#xD;
&#xD;
      The interactive intention-driven hand training robotic system is used for neuromuscular&#xD;
      rehabilitation of the hand and forearm. This can help stroke survivors to regain their hand&#xD;
      functions through motor relearning.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">July 31, 2022</completion_date>
  <primary_completion_date type="Actual">July 31, 2022</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>Action Research Arm Test (ARAT)</measure>
    <time_frame>3-month follow-up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment Upper Extremity (FMA-UE)</measure>
    <time_frame>3-month follow-up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Wolf Motor Function Test (WMFT)</measure>
    <time_frame>3-month follow-up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Modified Ashworth Scale (MAS)</measure>
    <time_frame>3-month follow-up</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">111</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>EMG-driven</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The hand training system functions as a biofeedback device which surface electromyography (EMG) sensors are used to capture the user's own muscle signals to activate the system for moving his/her paretic hand.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EMG-driven</intervention_name>
    <description>The EMG signals are processed and can be visualized with visual feedback to make sure the user actively engaging throughout a therapy session.</description>
    <arm_group_label>EMG-driven</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at least six months after the onset of a unilateral ischemic brain injury or&#xD;
             intracerebral haemorrhage&#xD;
&#xD;
          -  upper-limb motor impairments due to stroke&#xD;
&#xD;
          -  metacarpophalangeal and proximal interphalangeal joints of fingers can be extended to&#xD;
             180 degree passively&#xD;
&#xD;
          -  spasticity during extension at the finger joints is lower than 3 as measured by the&#xD;
             Modified Ashworth Scale&#xD;
&#xD;
          -  detectable voluntary EMG signals from the flexor digitorum and extensor digitorum&#xD;
             muscles of the paretic hand&#xD;
&#xD;
          -  have sufficient cognition to follow the experimental instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have other neurological, neuromuscular, and orthopedic diseases&#xD;
&#xD;
          -  have shoulder or arm contracture/pain&#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>
  <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>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>October 2022</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>October 19, 2022</last_update_submitted>
  <last_update_submitted_qc>October 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2022</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/NCT03808415
org study id: 2018.399
nct id: NCT03808415
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 interactive intention-driven hand training robotic system is used for neuromuscular
      rehabilitation of the hand and forearm. This can help stroke survivors to regain their hand
      functions through motor relearning.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Action Research Arm Test (ARAT)
time frame: 3-month follow-up
measure: Fugl-Meyer Assessment Upper Extremity (FMA-UE)
time frame: 3-month follow-up
measure: Wolf Motor Function Test (WMFT)
time frame: 3-month follow-up
measure: Modified Ashworth Scale (MAS)
time frame: 3-month follow-up
arm group label: EMG-driven
arm group type: Experimental
description: The hand training system functions as a biofeedback device which surface electromyography (EMG) sensors are used to capture the user's own muscle signals to activate the system for moving his/her paretic hand.
intervention type: Device
intervention name: EMG-driven
description: The EMG signals are processed and can be visualized with visual feedback to make sure the user actively engaging throughout a therapy session.
arm group label: EMG-driven
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
facility: 
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