<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/NCT02254343</url>
  </required_header>
  <id_info>
    <org_study_id>103-3564A3</org_study_id>
    <nct_id>NCT02254343</nct_id>
  </id_info>
  <brief_title>Effects of Proximal and Distal Robot-assisted Therapy Combined With Functional Training</brief_title>
  <official_title>Effects of Proximal and Distal Robot-assisted Therapy Combined With Functional Training on Stroke Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the training effects of robot-assisted therapy focus&#xD;
      on proximal part, distal part, or total segment of upper extremity, respectively.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change scores of Fugl-Meyer assessment(FMA)</measure>
    <time_frame>baseline, 2 weeks, 4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change scores of Box and block test (BBT)</measure>
    <time_frame>baseline, 2 weeks, 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Action research arm test (ARAT)</measure>
    <time_frame>baseline, 2 weeks, 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Medical Research Council scale (MRC)</measure>
    <time_frame>baseline, 2 weeks, 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Modified Ashworth scale (MAS)</measure>
    <time_frame>baseline, 2 weeks, 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Myoton</measure>
    <time_frame>baseline, 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Wolf Motor Function Test (WMFT)</measure>
    <time_frame>baseline, 2 weeks, 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI)</measure>
    <time_frame>baseline, 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Functional independent measure (FIM)</measure>
    <time_frame>baseline, 2 weeks, 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Stroke Impact Scale (SIS 3.0 version)</measure>
    <time_frame>baseline, 2 weeks, 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of EuroQol Quality of Life Scale (EQ-5D)</measure>
    <time_frame>baseline, 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Hand strength</measure>
    <time_frame>baseline, 2 weeks, 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Motor activity log (MAL)</measure>
    <time_frame>baseline, 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of ABILHAND Questionnaire</measure>
    <time_frame>baseline, 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of 10-meter walking test</measure>
    <time_frame>baseline, 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Nottingham Extended ADL Questionnaire (NEADL)</measure>
    <time_frame>baseline, 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Adelaide Activities Profile (AAP)</measure>
    <time_frame>baseline, 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Montreal Cognitive Assessment (MoCA)</measure>
    <time_frame>baseline, 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Number stroop test</measure>
    <time_frame>baseline, 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Accelerometer</measure>
    <time_frame>baseline, 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Revised Nottingham Sensory Assessment (rNSA)</measure>
    <time_frame>baseline, 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Algometer</measure>
    <time_frame>baseline, 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of kinematic analysis</measure>
    <time_frame>baseline, 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Adverse effects</measure>
    <time_frame>baseline, 2 weeks, 4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>proximal robot-assisted therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>treatment programs will target to shoulder and elbow portions of upper extremity via the InMotion2 robotic system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>distal robot-assisted therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the InMotion3 robot system will be used to execute treatment programs focus on wrist movements. It includes three degrees of freedom to allow wrist flexion/extension, abduction/adduction, and pronation/supination.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>individualized intensive therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>individualized occupational therapy which is dose-match to robot-assisted therapy, based on task-oriented principle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>proximal robot-assisted therapy</intervention_name>
    <arm_group_label>proximal robot-assisted therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>distal robot-assisted therapy</intervention_name>
    <arm_group_label>distal robot-assisted therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>individualized intensive therapy</intervention_name>
    <arm_group_label>individualized intensive therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  unilateral stroke that verified by CT scan&#xD;
&#xD;
          -  Time since stroke more than 6 months&#xD;
&#xD;
          -  moderate and mild upper limb motor impairment identified from the UE subtest of FMA&#xD;
             range from 10 to 50&#xD;
&#xD;
          -  Mini-Mental State Examination (MMSE) more than 24 points is needed to follow commands&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  serious visual or visual perception problems&#xD;
&#xD;
          -  orthopedic or other neurological problems occurred in recent 6 months&#xD;
&#xD;
          -  attend any other study in recent 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ching-Yi Wu, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital</name>
      <address>
        <city>Kwei-Shan, Tao-Yuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lo-Sheng Sanatorium and Hospital</name>
      <address>
        <city>Kwei-shan, Toayuan county</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>September 14, 2016</last_update_submitted>
  <last_update_submitted_qc>September 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stroke rehabilitation</keyword>
  <keyword>robot-assisted therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT02254343
org study id: 103-3564A3
nct id: NCT02254343
lead sponsor: 
has dmc: No
The purpose of this study is to compare the training effects of robot-assisted therapy focus
      on proximal part, distal part, or total segment of upper extremity, respectively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change scores of Fugl-Meyer assessment(FMA)
time frame: baseline, 2 weeks, 4 weeks
measure: Change scores of Box and block test (BBT)
time frame: baseline, 2 weeks, 4 weeks
measure: Change scores of Action research arm test (ARAT)
time frame: baseline, 2 weeks, 4 weeks
measure: Change scores of Medical Research Council scale (MRC)
time frame: baseline, 2 weeks, 4 weeks
measure: Change scores of Modified Ashworth scale (MAS)
time frame: baseline, 2 weeks, 4 weeks
measure: Change scores of Myoton
time frame: baseline, 4 weeks
measure: Change scores of Wolf Motor Function Test (WMFT)
time frame: baseline, 2 weeks, 4 weeks
measure: Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI)
time frame: baseline, 4 weeks
measure: Change scores of Functional independent measure (FIM)
time frame: baseline, 2 weeks, 4 weeks
measure: Change scores of Stroke Impact Scale (SIS 3.0 version)
time frame: baseline, 2 weeks, 4 weeks
measure: Change scores of EuroQol Quality of Life Scale (EQ-5D)
time frame: baseline, 4 weeks
measure: Change scores of Hand strength
time frame: baseline, 2 weeks, 4 weeks
measure: Change scores of Motor activity log (MAL)
time frame: baseline, 4 weeks
measure: Change scores of ABILHAND Questionnaire
time frame: baseline, 4 weeks
measure: Change scores of 10-meter walking test
time frame: baseline, 4 weeks
measure: Change scores of Nottingham Extended ADL Questionnaire (NEADL)
time frame: baseline, 4 weeks
measure: Change scores of Adelaide Activities Profile (AAP)
time frame: baseline, 4 weeks
measure: Change scores of Montreal Cognitive Assessment (MoCA)
time frame: baseline, 4 weeks
measure: Change scores of Number stroop test
time frame: baseline, 4 weeks
measure: Change scores of Accelerometer
time frame: baseline, 4 weeks
measure: Change scores of Revised Nottingham Sensory Assessment (rNSA)
time frame: baseline, 4 weeks
measure: Change scores of Algometer
time frame: baseline, 4 weeks
measure: Change scores of kinematic analysis
time frame: baseline, 4 weeks
measure: Change scores of Adverse effects
time frame: baseline, 2 weeks, 4 weeks
arm group label: proximal robot-assisted therapy
arm group type: Experimental
description: treatment programs will target to shoulder and elbow portions of upper extremity via the InMotion2 robotic system
arm group label: distal robot-assisted therapy
arm group type: Experimental
description: the InMotion3 robot system will be used to execute treatment programs focus on wrist movements. It includes three degrees of freedom to allow wrist flexion/extension, abduction/adduction, and pronation/supination.
arm group label: individualized intensive therapy
arm group type: Active Comparator
description: individualized occupational therapy which is dose-match to robot-assisted therapy, based on task-oriented principle.
intervention type: Device
intervention name: proximal robot-assisted therapy
arm group label: proximal robot-assisted therapy
intervention type: Device
intervention name: distal robot-assisted therapy
arm group label: distal robot-assisted therapy
intervention type: Behavioral
intervention name: individualized intensive therapy
arm group label: individualized intensive therapy
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ching-Yi Wu, ScD
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
facility: 
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Stroke