<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/NCT02247674</url>
  </required_header>
  <id_info>
    <org_study_id>NYMU20140829</org_study_id>
    <nct_id>NCT02247674</nct_id>
  </id_info>
  <brief_title>Bilateral Movement Training for People With Stroke</brief_title>
  <official_title>Effects of Computer-aided Interlimb Force Coupling Training on Paretic Hand and Arm Motor Control Following Chronic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chueh-Ho Lin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Yang Ming University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Yang Ming University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesized that bilateral handgrip force training would result in&#xD;
      significant improvements in paretic hand, arm movements and daily functional performances. In&#xD;
      order to investigate whether the improvement of paretic hand could facilitate the motor&#xD;
      recovery of paretic arm and functional performances, the investigators also hypothesized that&#xD;
      motor recovery and functional performances improvements of paretic arm and hand have strongly&#xD;
      correlation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To investigate the training effects of interlimb force coupling training on&#xD;
      paretic hand and upper extremity outcomes in patients with chronic stroke; to analyze the&#xD;
      relationship between motor recovery of paretic hand, arm and functional abilities.&#xD;
&#xD;
      Design: A double-blind randomized controlled trial with outcome assessment at baseline and&#xD;
      after 4 weeks intervention.&#xD;
&#xD;
      Setting: Department of physical medicine and rehabilitation in Taipei Veterans General&#xD;
      Hospital.&#xD;
&#xD;
      Participants: Thirty-three subjects (mean age = 55.1 ± 10.5 y/o) with chronic stroke were&#xD;
      recruited and randomized assigned to training (n=16) and control group (n=17).&#xD;
&#xD;
      Interventions: Interlimb force coupling training task included different gripforce generation&#xD;
      on the both hands.&#xD;
&#xD;
      Main Outcome Measures: Barthel Index (BI), and the upper extremity motor control of&#xD;
      Fugl-Meyer Assessment (FMA-UE), Motor Assessment Score (MAS), and the Wolf Motor Function&#xD;
      Test (WMFT). All assessment was executed by a blinded evaluator, and data management and&#xD;
      statistical analysis was also conducted by a blinded statistic researcher.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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 Extremity motor control of Fugl-Meyer Assessment (FMA-UE)</measure>
    <time_frame>before and after 4 weeks intervention</time_frame>
    <description>Outcome measure was assessed before and after 4 weeks intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Barthel Index (BI)</measure>
    <time_frame>before and after 4 weeks intervention</time_frame>
    <description>Outcome measure was assessed before and after 4 weeks intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor Assessment Score (MAS)</measure>
    <time_frame>before and after 4 weeks intervention</time_frame>
    <description>Outcome measure was assessed before and after 4 weeks intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wolf Motor Function Test (WMFT)</measure>
    <time_frame>before and after 4 weeks intervention</time_frame>
    <description>Outcome measure was assessed before and after 4 weeks intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Stroke</condition>
  <condition>Cerebrovascular Accident</condition>
  <condition>Cardiovascular Disease</condition>
  <condition>Brain Injury</condition>
  <arm_group>
    <arm_group_label>Education &amp; training consultation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Education and training consultations were provided for subjects in control group during study period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bilateral movement training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise training of bilateral isometric handgrip force training group consisted of 60 minutes of bilateral isometric handgrip force training 3 days per week for 4 weeks (total 12 sessions)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bilateral movement training</intervention_name>
    <description>Exercise training of bilateral isometric handgrip force training group consisted of 60 minutes of bilateral isometric handgrip force training 3 days per week for 4 weeks (total 12 sessions)</description>
    <arm_group_label>Bilateral movement training</arm_group_label>
    <arm_group_label>Education &amp; training consultation</arm_group_label>
    <other_name>Coupling movement</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. at least 6 months since stroke&#xD;
&#xD;
          2. three or fewer incidents of unilateral stroke confirmed by taking the participant's&#xD;
             medical history ability to follow researcher's instructions&#xD;
&#xD;
          3. ability to flex and extend the paretic arm and hand&#xD;
&#xD;
          4. Modified Ashworth Score (MAS) ≦3 for wrist and finger joints&#xD;
&#xD;
          5. Mini-Mental State Examination (MMSE) score should 24 or higher&#xD;
&#xD;
          6. no other orthopedic neurological disorders&#xD;
&#xD;
          7. Brunnstrom stage 3 or 4&#xD;
&#xD;
          8. no joint in other experimental rehabilitation or drug studies 21&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. unstable cardiovascular conditions&#xD;
&#xD;
          2. uncontrolled hypertension (190/110 mm Hg)&#xD;
&#xD;
          3. severe orthopedic or pain conditions&#xD;
&#xD;
          4. dementia (Mini-Mental State Examination score &lt; 22)&#xD;
&#xD;
          5. aphasia with inability to follow researcher's commands&#xD;
&#xD;
          6. severe joint contracture of bilateral upper extremities that would impact the movement&#xD;
             performances of upper extremities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>28 Years</minimum_age>
    <maximum_age>81 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wen-Hsu Sung, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Physical Therapy and Assistive Technology, National Yang-Ming University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 31, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 19, 2014</last_update_submitted>
  <last_update_submitted_qc>September 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>National Yang Ming University</investigator_affiliation>
    <investigator_full_name>Chueh-Ho Lin</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>Stroke, Cerebrovascular accident, Rehabilitation, Upper extremity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT02247674
org study id: NYMU20140829
nct id: NCT02247674
lead sponsor: 
collaborator: 
has dmc: Yes
The investigators hypothesized that bilateral handgrip force training would result in
      significant improvements in paretic hand, arm movements and daily functional performances. In
      order to investigate whether the improvement of paretic hand could facilitate the motor
      recovery of paretic arm and functional performances, the investigators also hypothesized that
      motor recovery and functional performances improvements of paretic arm and hand have strongly
      correlation.
Objective: To investigate the training effects of interlimb force coupling training on
      paretic hand and upper extremity outcomes in patients with chronic stroke; to analyze the
      relationship between motor recovery of paretic hand, arm and functional abilities.

      Design: A double-blind randomized controlled trial with outcome assessment at baseline and
      after 4 weeks intervention.

      Setting: Department of physical medicine and rehabilitation in Taipei Veterans General
      Hospital.

      Participants: Thirty-three subjects (mean age = 55.1 ± 10.5 y/o) with chronic stroke were
      recruited and randomized assigned to training (n=16) and control group (n=17).

      Interventions: Interlimb force coupling training task included different gripforce generation
      on the both hands.

      Main Outcome Measures: Barthel Index (BI), and the upper extremity motor control of
      Fugl-Meyer Assessment (FMA-UE), Motor Assessment Score (MAS), and the Wolf Motor Function
      Test (WMFT). All assessment was executed by a blinded evaluator, and data management and
      statistical analysis was also conducted by a blinded statistic researcher.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Upper Extremity motor control of Fugl-Meyer Assessment (FMA-UE)
time frame: before and after 4 weeks intervention
description: Outcome measure was assessed before and after 4 weeks intervention.
measure: Barthel Index (BI)
time frame: before and after 4 weeks intervention
description: Outcome measure was assessed before and after 4 weeks intervention.
measure: Motor Assessment Score (MAS)
time frame: before and after 4 weeks intervention
description: Outcome measure was assessed before and after 4 weeks intervention.
measure: Wolf Motor Function Test (WMFT)
time frame: before and after 4 weeks intervention
description: Outcome measure was assessed before and after 4 weeks intervention.
arm group label: Education & training consultation
arm group type: Placebo Comparator
description: Education and training consultations were provided for subjects in control group during study period.
arm group label: Bilateral movement training
arm group type: Experimental
description: Exercise training of bilateral isometric handgrip force training group consisted of 60 minutes of bilateral isometric handgrip force training 3 days per week for 4 weeks (total 12 sessions)
intervention type: Procedure
intervention name: Bilateral movement training
description: Exercise training of bilateral isometric handgrip force training group consisted of 60 minutes of bilateral isometric handgrip force training 3 days per week for 4 weeks (total 12 sessions)
arm group label: Bilateral movement training
arm group label: Education & training consultation
other name: Coupling movement
criteria: 
gender: All
minimum age: 28 Years
maximum age: 81 Years
healthy volunteers: No
last name: Wen-Hsu Sung, PhD
role: Study Chair
affiliation: Department of Physical Therapy and Assistive Technology, National Yang-Ming University
facility: 
country: Taiwan
responsible party type: Sponsor-Investigator
investigator affiliation: National Yang Ming University
investigator full name: Chueh-Ho Lin
investigator title: Dr.
mesh term: Stroke
mesh term: Brain Injuries
mesh term: Cardiovascular Diseases