<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/NCT03286309</url>
  </required_header>
  <id_info>
    <org_study_id>2017.396-T</org_study_id>
    <nct_id>NCT03286309</nct_id>
  </id_info>
  <brief_title>Soft Robotic Hand System for Stroke Rehabilitation</brief_title>
  <official_title>Soft Robotic Hand System for Stroke Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The soft robotic system could provide objective and quantifiable measures of subject&#xD;
      performance. By combining voluntary motor intention and the robotic hand technology, the&#xD;
      system will facilitate the recovery process of stroke patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 12, 2018</start_date>
  <completion_date type="Anticipated">July 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2022</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Upper limb Fugl Meyer Assessment</measure>
    <time_frame>3-month follow up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Action Research Arm Test</measure>
    <time_frame>3-month follow up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Ashworth Scale</measure>
    <time_frame>3-month follow up</time_frame>
    <description>Scale from 0 to 4, whereas 0 is no increase in tone and 4 is limb rigid in flexion or extension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Box and Block Test</measure>
    <time_frame>3-month follow up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Max Voluntary Grip Force</measure>
    <time_frame>3-month follow up</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>EMG-driven soft robot hand</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects will receive EMG-driven soft robot hand system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>subjects will receive passive pre-programmed soft robot hand system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>soft robot hand system</intervention_name>
    <description>subjects will wear the soft robot hand system and receive 60 minutes (including preparation time) hand exercise.</description>
    <arm_group_label>EMG-driven soft robot hand</arm_group_label>
    <arm_group_label>sham group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. at chronic stage (6 months after the onset of stroke) with a pure unilateral motor&#xD;
             paresis after a stroke (ischemic or hemorrhagic);&#xD;
&#xD;
          2. sufficient cognition to follow simple instructions as well as understand the content&#xD;
             and purpose of the study;&#xD;
&#xD;
          3. able to sit up for 45 minutes (with or without assistance).&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Patients with severe dysphasia (either expressive or comprehensive) with inadequate&#xD;
             communication;&#xD;
&#xD;
          2. any additional medical or psychological condition affecting their ability to comply&#xD;
             with the study protocol;&#xD;
&#xD;
          3. history of other neurological disease, psychiatric disorder, including alcoholism and&#xD;
             substance abuse.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raymond Kai-yu Tong, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Biomedical Engineering, CUHK</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Raymond Kai-yu Tong, PhD</last_name>
    <phone>+852 3943 8454</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>Shatin</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>May 2022</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 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</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/NCT03286309
org study id: 2017.396-T
nct id: NCT03286309
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The soft robotic system could provide objective and quantifiable measures of subject
      performance. By combining voluntary motor intention and the robotic hand technology, the
      system will facilitate the recovery process of stroke patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Upper limb Fugl Meyer Assessment
time frame: 3-month follow up
measure: Action Research Arm Test
time frame: 3-month follow up
measure: Modified Ashworth Scale
time frame: 3-month follow up
description: Scale from 0 to 4, whereas 0 is no increase in tone and 4 is limb rigid in flexion or extension
measure: Box and Block Test
time frame: 3-month follow up
measure: Max Voluntary Grip Force
time frame: 3-month follow up
arm group label: EMG-driven soft robot hand
arm group type: Experimental
description: subjects will receive EMG-driven soft robot hand system.
arm group label: sham group
arm group type: Placebo Comparator
description: subjects will receive passive pre-programmed soft robot hand system.
intervention type: Device
intervention name: soft robot hand system
description: subjects will wear the soft robot hand system and receive 60 minutes (including preparation time) hand exercise.
arm group label: EMG-driven soft robot hand
arm group label: sham group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Raymond Kai-yu Tong, PhD
role: Principal Investigator
affiliation: Department of Biomedical Engineering, CUHK
last name: Raymond Kai-yu Tong, PhD
phone: +852 3943 8454
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
mesh term: Stroke
sharing ipd: No