<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/NCT03042455</url>
  </required_header>
  <id_info>
    <org_study_id>1-2014-0083</org_study_id>
    <nct_id>NCT03042455</nct_id>
  </id_info>
  <brief_title>Combined Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Upper Arm Training in Subacute Stroke Patients</brief_title>
  <official_title>Combined Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Upper Arm Training in Subacute Stroke Patients : Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</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>
      This study was designed to establish the clinical evidence for effect of Robot-Assisted upper&#xD;
      arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function of&#xD;
      subacute stroke patients.&#xD;
&#xD;
        -  Purpose : to elucidate the effect of Robot-Assisted upper arm training and Repetitive&#xD;
           Transcranial Magnetic Stimulation on upper limb function of stroke patients compared to&#xD;
           conventional occupational therapy&#xD;
&#xD;
        -  Subjects : total 99 patients with stroke whose upper limb functions are impaired&#xD;
&#xD;
        -  Intervention : 4 weeks of therapy (5 days per week)&#xD;
&#xD;
        -  Studies : upper limb functional assessment (FMA, MFT, WMFT), computerized motion&#xD;
           analysis&#xD;
&#xD;
        -  Evaluation plan : 1) pre-intervention, 2) post-2 weeks of intervention, 3) post-4 weeks&#xD;
           of intervention, 4) 4 weeks after end of intervention&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 18, 2015</start_date>
  <completion_date type="Actual">June 26, 2018</completion_date>
  <primary_completion_date type="Actual">June 26, 2018</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment (FMA)</measure>
    <time_frame>1 minute before the first intervention</time_frame>
    <description>The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment (FMA)</measure>
    <time_frame>2 weeks after the first intervention</time_frame>
    <description>The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment (FMA)</measure>
    <time_frame>4 weeks after the first intervention</time_frame>
    <description>The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment (FMA)</measure>
    <time_frame>4 weeks after the final intervention</time_frame>
    <description>The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wolf motor function test</measure>
    <time_frame>1 minute before the first intervention</time_frame>
    <description>The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wolf motor function test</measure>
    <time_frame>2 weeks after the first intervention</time_frame>
    <description>The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wolf motor function test</measure>
    <time_frame>4 weeks after the first intervention</time_frame>
    <description>The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wolf motor function test</measure>
    <time_frame>4 weeks after the final intervention</time_frame>
    <description>The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Manual Function test</measure>
    <time_frame>1 minute before the first intervention</time_frame>
    <description>The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Manual Function test</measure>
    <time_frame>2 weeks after the first intervention</time_frame>
    <description>The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Manual Function test</measure>
    <time_frame>4 weeks after the first intervention</time_frame>
    <description>The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Manual Function test</measure>
    <time_frame>4 weeks after the final intervention</time_frame>
    <description>The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kinematic data of computerized 3D motion analysis</measure>
    <time_frame>1 minute before the first intervention</time_frame>
    <description>D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kinematic data of computerized 3D motion analysis</measure>
    <time_frame>2 weeks after the first intervention</time_frame>
    <description>D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kinematic data of computerized 3D motion analysis</measure>
    <time_frame>4 weeks after the first intervention</time_frame>
    <description>D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kinematic data of computerized 3D motion analysis</measure>
    <time_frame>4 weeks after the final intervention</time_frame>
    <description>D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Robot and rTMS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation group(intervention group 1)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Robot</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Robot-Assisted upper arm training group(intervention group2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional training group(control group)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Armeo and rTMS</intervention_name>
    <description>The Armeo, a robot with a spring mechanism allowing adjustable arm weight support, can generate assistive forces of up to 66N in flexion/extension and up to 30N for the arm and forearm respectively. This robot integrates seven angle sensors and one pressure sensor that allow direct interaction between the motion of the patient's arm and the associated therapy software. rTMS is a magnetic method used to stimulate small regions of the brain.&#xD;
The Robot and rTMS group will receive the robot-assisted upper arm training and rTMS for 5 times per week, for 4 weeks. And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.</description>
    <arm_group_label>Robot and rTMS</arm_group_label>
    <other_name>Robot-Assisted upper arm training(Armeo)</other_name>
    <other_name>Repetitive Transcranial Magnetic Stimulation(rTMS)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Armeo</intervention_name>
    <description>The Armeo, a robot with a spring mechanism allowing adjustable arm weight support, can generate assistive forces of up to 66N in flexion/extension and up to 30N for the arm and forearm respectively. This robot integrates seven angle sensors and one pressure sensor that allow direct interaction between the motion of the patient's arm and the associated therapy software. The Robot group will receive the robot-assisted upper arm training for 30 minutes daily 5 times per week, for 4 weeks. And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.</description>
    <arm_group_label>Robot</arm_group_label>
    <other_name>Robot-Assisted upper arm training(Armeo)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>The conventional group will receive occupational therapy for 30 minutes daily 5 times per week, for 4 weeks instead of Robot or rTMS. And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.</description>
    <arm_group_label>Conventional</arm_group_label>
    <other_name>conventional training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Upper FMA 7-38&#xD;
&#xD;
          -  Hemiplegic patients within 6months after stroke onset&#xD;
&#xD;
          -  male or female, 20 years older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cognitive impairment who are unable to comply with protocol-required&#xD;
             procedure&#xD;
&#xD;
          -  Quadriplegic or double hemiplegic patients&#xD;
&#xD;
          -  Patients with musculoskeletal disease, peripheral nerve disease in upper extremity&#xD;
&#xD;
          -  Patients with lower motor neuron disease&#xD;
&#xD;
          -  Patients who cannot perform rTMS&#xD;
&#xD;
          -  Pregnant woman&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Rehabilitation Medicine, Severance Hospital, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>March 14, 2019</last_update_submitted>
  <last_update_submitted_qc>March 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>Undecided</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/NCT03042455
org study id: 1-2014-0083
nct id: NCT03042455
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study was designed to establish the clinical evidence for effect of Robot-Assisted upper
      arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function of
      subacute stroke patients.

        -  Purpose : to elucidate the effect of Robot-Assisted upper arm training and Repetitive
           Transcranial Magnetic Stimulation on upper limb function of stroke patients compared to
           conventional occupational therapy

        -  Subjects : total 99 patients with stroke whose upper limb functions are impaired

        -  Intervention : 4 weeks of therapy (5 days per week)

        -  Studies : upper limb functional assessment (FMA, MFT, WMFT), computerized motion
           analysis

        -  Evaluation plan : 1) pre-intervention, 2) post-2 weeks of intervention, 3) post-4 weeks
           of intervention, 4) 4 weeks after end of intervention
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Fugl-Meyer Assessment (FMA)
time frame: 1 minute before the first intervention
description: The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
measure: Fugl-Meyer Assessment (FMA)
time frame: 2 weeks after the first intervention
description: The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
measure: Fugl-Meyer Assessment (FMA)
time frame: 4 weeks after the first intervention
description: The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
measure: Fugl-Meyer Assessment (FMA)
time frame: 4 weeks after the final intervention
description: The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
measure: Wolf motor function test
time frame: 1 minute before the first intervention
description: The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
measure: Wolf motor function test
time frame: 2 weeks after the first intervention
description: The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
measure: Wolf motor function test
time frame: 4 weeks after the first intervention
description: The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
measure: Wolf motor function test
time frame: 4 weeks after the final intervention
description: The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
measure: Manual Function test
time frame: 1 minute before the first intervention
description: The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
measure: Manual Function test
time frame: 2 weeks after the first intervention
description: The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
measure: Manual Function test
time frame: 4 weeks after the first intervention
description: The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
measure: Manual Function test
time frame: 4 weeks after the final intervention
description: The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
measure: Kinematic data of computerized 3D motion analysis
time frame: 1 minute before the first intervention
description: D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
measure: Kinematic data of computerized 3D motion analysis
time frame: 2 weeks after the first intervention
description: D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
measure: Kinematic data of computerized 3D motion analysis
time frame: 4 weeks after the first intervention
description: D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
measure: Kinematic data of computerized 3D motion analysis
time frame: 4 weeks after the final intervention
description: D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
arm group label: Robot and rTMS
arm group type: Experimental
description: Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation group(intervention group 1)
arm group label: Robot
arm group type: Experimental
description: Robot-Assisted upper arm training group(intervention group2)
arm group label: Conventional
arm group type: Active Comparator
description: Conventional training group(control group)
intervention type: Device
intervention name: Armeo and rTMS
description: The Armeo, a robot with a spring mechanism allowing adjustable arm weight support, can generate assistive forces of up to 66N in flexion/extension and up to 30N for the arm and forearm respectively. This robot integrates seven angle sensors and one pressure sensor that allow direct interaction between the motion of the patient's arm and the associated therapy software. rTMS is a magnetic method used to stimulate small regions of the brain.
The Robot and rTMS group will receive the robot-assisted upper arm training and rTMS for 5 times per week, for 4 weeks. And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.
arm group label: Robot and rTMS
other name: Robot-Assisted upper arm training(Armeo)
other name: Repetitive Transcranial Magnetic Stimulation(rTMS)
intervention type: Device
intervention name: Armeo
description: The Armeo, a robot with a spring mechanism allowing adjustable arm weight support, can generate assistive forces of up to 66N in flexion/extension and up to 30N for the arm and forearm respectively. This robot integrates seven angle sensors and one pressure sensor that allow direct interaction between the motion of the patient's arm and the associated therapy software. The Robot group will receive the robot-assisted upper arm training for 30 minutes daily 5 times per week, for 4 weeks. And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.
arm group label: Robot
other name: Robot-Assisted upper arm training(Armeo)
intervention type: Other
intervention name: Control group
description: The conventional group will receive occupational therapy for 30 minutes daily 5 times per week, for 4 weeks instead of Robot or rTMS. And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.
arm group label: Conventional
other name: conventional training
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: Undecided