<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/NCT03752775</url>
  </required_header>
  <id_info>
    <org_study_id>ITS/073/16</org_study_id>
    <nct_id>NCT03752775</nct_id>
  </id_info>
  <brief_title>Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke</brief_title>
  <official_title>Mobile Electromyography (EMG)-Driven Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hong Kong Polytechnic University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A new clothing robotic arm was developed for multi-joint coordinated upper limb&#xD;
      rehabilitation after stroke. Patients after stroke will be recruited to evaluate the&#xD;
      rehabilitation effectiveness of the device assisted upper limb rehabilitation. Both patients&#xD;
      with chronic stroke and subacute stroke will be investigated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A new robotic arm, named mobile exo-neuro-musculo-skeleton, was developed for upper limb&#xD;
      rehabilitation. The system integrated the advantages of exoskeleton, soft robot, and&#xD;
      neuromuscular electrical stimulation. It is noninvasive, light in weight, comfortable to&#xD;
      wear, and can support the motions at the elbow, the wrist and the fingers. The device is a&#xD;
      mobile system interfaced with a mobile app by a user.&#xD;
&#xD;
      The device assisted upper limb rehabilitation will be applied to inpatients with subacute&#xD;
      stroke. The rehabilitation effects on the motor restoration in the upper limb will be&#xD;
      compared with the conventional physical and occupational therapies. The rehabilitation&#xD;
      effects of the device assisted training also will be evaluated on patients with chronic&#xD;
      stroke. The motor improvements after training will be investigated by comparing the pre- and&#xD;
      post- clinical assessments. It is hypothesized that the device assisted upper limb&#xD;
      rehabilitation will be effective in both subacute and chronic patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Anticipated">August 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>
    <intervention_model_description>The device assisted treatment will be administrated to patients with subacute stroke and chronic stroke. The subacute stroke group will be compared in parallel with a control group receive the conventional physical and occupational therapies.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment (FMA) of the Upper Limb before the training</measure>
    <time_frame>For each subject, the FMA score will be measured one day before the training.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment (FMA) of the Upper Limb after the training</measure>
    <time_frame>For each subject, the FMA score will be measured one day after the 20-session training program.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment (FMA) of the Upper Limb 3-month follow-up</measure>
    <time_frame>For each subject, the FMA score will be measured 3 months later after the last day of the training.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Modified Ashworth Scale (MAS)</measure>
    <time_frame>For each subject, the MAS score will be measure one day before the training, one day after the 20-session training program, and 3 months later after the last day of the training.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Action Research Arm Test (ARAT)</measure>
    <time_frame>For each subject, the ARAT score will be measure one day before the training, one day after the 20-session training program, and 3 months later after the last day of the training.</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Upper Limb Rehabilitation</condition>
  <arm_group>
    <arm_group_label>subacute device assisted group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>subacute conventional group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>chronic device assisted group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Robot assisted upper limb rehabilitation</intervention_name>
    <description>The patients in the experimental and the other arms will receive 20 session device assisted upper limb rehabilitation. In each session, a subject will conduct multi-joint coordinated upper limb motions for 1 hour.</description>
    <arm_group_label>chronic device assisted group</arm_group_label>
    <arm_group_label>subacute conventional group</arm_group_label>
    <arm_group_label>subacute device assisted group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For the subacute groups:&#xD;
&#xD;
          -  Two weeks after the onset of stroke, however less than 0.5 year&#xD;
&#xD;
          -  Mini-Mental State Examination (MMSE)&gt;21&#xD;
&#xD;
          -  Able to sit up for at least 1 hour&#xD;
&#xD;
          -  Fugl-Meyer Assessment (FMA) upper limb &lt;30&#xD;
&#xD;
          -  Modified Ashworth Score (MAS) at the elbow, wrist and fingers &lt;3&#xD;
&#xD;
          -  Detectable EMG on the target driving muscles (i.e., 3 times of the standard deviation&#xD;
             above the baseline)&#xD;
&#xD;
        For the chronic device assisted group:&#xD;
&#xD;
          -  At least 0.5 year after the onset of stroke&#xD;
&#xD;
          -  Mini-Mental State Examination (MMSE)&gt;21&#xD;
&#xD;
          -  Able to sit up for at least 1 hour&#xD;
&#xD;
          -  Fugl-Meyer Assessment (FMA) upper limb &lt;30&#xD;
&#xD;
          -  Modified Ashworth Score (MAS) at the elbow, wrist and fingers &lt;3&#xD;
&#xD;
          -  Detectable EMG on the target driving muscles (i.e., 3 times of the standard deviation&#xD;
             above the baseline)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects will be excluded if they do not meet the above inclusion criteria, or had the&#xD;
        following conditions:&#xD;
&#xD;
          -  Currently pregnant&#xD;
&#xD;
          -  Dysphasia (language deficiency)&#xD;
&#xD;
          -  Post-stroke neglect&#xD;
&#xD;
          -  Pacemaker implantation,&#xD;
&#xD;
          -  Involved in drug studies, other clinical trials, or concurrent&#xD;
             medication/occupational/physical treatments on the upper limb&#xD;
&#xD;
          -  The overall medical condition not suitable for the training (e.g., severe cardiac&#xD;
             problem, unstable blood pressure, etc.).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Xiaoling Hu, PhD</last_name>
    <phone>34003206</phone>
    <email>xiaoling.hu@polyu.edu.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Hong Kong Polytechnic University</name>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaoling Hu, Ph.D.</last_name>
      <phone>+852 34003205</phone>
      <email>xiaoling.hu@polyu.edu.hk</email>
    </contact>
    <investigator>
      <last_name>Xiaoling Hu, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>August 23, 2022</last_update_submitted>
  <last_update_submitted_qc>August 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
    <investigator_full_name>Xiaoling Hu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>upper limb</keyword>
  <keyword>Joint coordination</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/NCT03752775
org study id: ITS/073/16
nct id: NCT03752775
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A new clothing robotic arm was developed for multi-joint coordinated upper limb
      rehabilitation after stroke. Patients after stroke will be recruited to evaluate the
      rehabilitation effectiveness of the device assisted upper limb rehabilitation. Both patients
      with chronic stroke and subacute stroke will be investigated.
A new robotic arm, named mobile exo-neuro-musculo-skeleton, was developed for upper limb
      rehabilitation. The system integrated the advantages of exoskeleton, soft robot, and
      neuromuscular electrical stimulation. It is noninvasive, light in weight, comfortable to
      wear, and can support the motions at the elbow, the wrist and the fingers. The device is a
      mobile system interfaced with a mobile app by a user.

      The device assisted upper limb rehabilitation will be applied to inpatients with subacute
      stroke. The rehabilitation effects on the motor restoration in the upper limb will be
      compared with the conventional physical and occupational therapies. The rehabilitation
      effects of the device assisted training also will be evaluated on patients with chronic
      stroke. The motor improvements after training will be investigated by comparing the pre- and
      post- clinical assessments. It is hypothesized that the device assisted upper limb
      rehabilitation will be effective in both subacute and chronic patients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The device assisted treatment will be administrated to patients with subacute stroke and chronic stroke. The subacute stroke group will be compared in parallel with a control group receive the conventional physical and occupational therapies.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Fugl-Meyer Assessment (FMA) of the Upper Limb before the training
time frame: For each subject, the FMA score will be measured one day before the training.
measure: Fugl-Meyer Assessment (FMA) of the Upper Limb after the training
time frame: For each subject, the FMA score will be measured one day after the 20-session training program.
measure: Fugl-Meyer Assessment (FMA) of the Upper Limb 3-month follow-up
time frame: For each subject, the FMA score will be measured 3 months later after the last day of the training.
measure: Modified Ashworth Scale (MAS)
time frame: For each subject, the MAS score will be measure one day before the training, one day after the 20-session training program, and 3 months later after the last day of the training.
measure: Action Research Arm Test (ARAT)
time frame: For each subject, the ARAT score will be measure one day before the training, one day after the 20-session training program, and 3 months later after the last day of the training.
arm group label: subacute device assisted group
arm group type: Experimental
arm group label: subacute conventional group
arm group type: Active Comparator
arm group label: chronic device assisted group
arm group type: Other
intervention type: Device
intervention name: Robot assisted upper limb rehabilitation
description: The patients in the experimental and the other arms will receive 20 session device assisted upper limb rehabilitation. In each session, a subject will conduct multi-joint coordinated upper limb motions for 1 hour.
arm group label: chronic device assisted group
arm group label: subacute conventional group
arm group label: subacute device assisted group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Xiaoling Hu, PhD
phone: 34003206
email: xiaoling.hu@polyu.edu.hk
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: Xiaoling Hu
investigator title: Principal Investigator
mesh term: Stroke
sharing ipd: No