<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/NCT02228863</url>
  </required_header>
  <id_info>
    <org_study_id>NRC-2014-01-005</org_study_id>
    <nct_id>NCT02228863</nct_id>
  </id_info>
  <brief_title>Upper Extremity Rehabilitation Using Robot and Botulinum Toxin</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Rehabilitation Center, Seoul, Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Rehabilitation Center, Seoul, Korea</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Concomitant use of botulinum toxin and robot would make better results regarding upper&#xD;
      extremity function compared to robot, botulinum toxin, or no intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2014</start_date>
  <primary_completion_date type="Anticipated">February 2017</primary_completion_date>
  <phase>Phase 4</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 of Fugl-Meyer Assessment</measure>
    <time_frame>Fugl-Meyer Assessment change from baseline at 8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Kinematic data</measure>
    <time_frame>Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline</time_frame>
    <description>Kinematic data from motion analysis (Vicon) Kinematic data from Inmotion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spasticity of elbow and shoulder joint</measure>
    <time_frame>baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline</time_frame>
    <description>Modified Ashworth scale of elbow and shoulder joint Modified Tardieu scale of elbow and shoulder joint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical research council scale of elbow and shoulder joint strength</measure>
    <time_frame>baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Painless range of motion of elbow and shoulder joint</measure>
    <time_frame>baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>numeric rating scale of pain of elbow and shoulder joint</measure>
    <time_frame>baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Associated reaction rating scale</measure>
    <time_frame>baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>surface electromyography data from bilateral upper extremities</measure>
    <time_frame>baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral activation system/behavioral inhition system scale</measure>
    <time_frame>baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline</time_frame>
    <description>In terms of motivation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Controlled Oral Word Association Test</measure>
    <time_frame>baseline, 5ays of Inmotion, 20 days of Inmotion</time_frame>
    <description>Controlled Oral Word Association Test during baseline, 5 days of Inmotion, 20 days of Inmotion.&#xD;
The test was done at rest and with Inmotion trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fugl-Meyer Assessment</measure>
    <time_frame>Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke impact scale</measure>
    <time_frame>baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck's depression index</measure>
    <time_frame>baseline, 4 weeks, 8 weeks, and 12 weeks from baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction about the intervention</measure>
    <time_frame>baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse event</measure>
    <time_frame>From baseline to 12 weeks from the baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digit span test</measure>
    <time_frame>baseline, 5days after Inmotion, 20 days after Inmotion.</time_frame>
    <description>Digit span test(forward, backward) during baseline, 5 days of Inmotion, 20 days of Inmotion.&#xD;
The test was done at rest and with Inmotion trial</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">348</enrollment>
  <condition>Stroke</condition>
  <condition>Spasticity</condition>
  <arm_group>
    <arm_group_label>Early Inmotion and Botox</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Concomitant use of Inmotion and botulinum toxin from the baseline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Botox, then Inmotion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Inmotion training 4 weeks after botulinum toxin injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inmotion, then Botox</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>From the baseline Inmotion, then Botox injection at 4 weeks after baseline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Late Inmotion and Botox</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>No intervention, then Inmotion and Botox injection at 4 weeks from the baseline</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early Inmotion and Botox</intervention_name>
    <description>Concomitant use of Inmotion and Botox from the baseline</description>
    <arm_group_label>Early Inmotion and Botox</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Botox, then Inmotion</intervention_name>
    <description>At baseline Botox injection and 4 weeks after Inmotion</description>
    <arm_group_label>Botox, then Inmotion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Inmotion, then Botox</intervention_name>
    <description>Inmotion from the baseline, then Botox injection at 4 weeks after baseline</description>
    <arm_group_label>Inmotion, then Botox</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Late Inmotion and Botox</intervention_name>
    <description>No intervention until 4 weeks from the baseline. Then Inmotion and Botox injection</description>
    <arm_group_label>Late Inmotion and Botox</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hemiplegic patients secondary to first cerebrovascular accidents&#xD;
&#xD;
          -  Shoulder or Elbow flexor spasticity above or modified ashworth scale 1+&#xD;
&#xD;
          -  Cognitively intact enough to understand and follow the instructions from the&#xD;
             investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of surgery of affected upper limb&#xD;
&#xD;
          -  Fracture of affected upper limb&#xD;
&#xD;
          -  Recent history of botulinum toxin injection within 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joon-Ho Shin, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Rehabilitation Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Joon-Ho Shin, MS</last_name>
    <phone>82-2-901-1884</phone>
    <email>asfreelyas@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Rehabilitation Center</name>
      <address>
        <city>Seoul</city>
        <zip>142884</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joon-Ho Shin, MS</last_name>
      <phone>82-901-1884</phone>
      <email>asfreelyas@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Joon-Ho Shin, MS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <link>
    <url>http://nrc.go.kr</url>
    <description>Site of the present study</description>
  </link>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 23, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>August 27, 2014</last_update_submitted>
  <last_update_submitted_qc>August 27, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Rehabilitation Center, Seoul, Korea</investigator_affiliation>
    <investigator_full_name>Joon-Ho Shin</investigator_full_name>
    <investigator_title>Team manager</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Spasticity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</mesh_term>
  </intervention_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/NCT02228863
org study id: NRC-2014-01-005
nct id: NCT02228863
lead sponsor: 
has dmc: No
Concomitant use of botulinum toxin and robot would make better results regarding upper
      extremity function compared to robot, botulinum toxin, or no intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change of Fugl-Meyer Assessment
time frame: Fugl-Meyer Assessment change from baseline at 8 weeks
measure: Kinematic data
time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
description: Kinematic data from motion analysis (Vicon) Kinematic data from Inmotion
measure: Spasticity of elbow and shoulder joint
time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
description: Modified Ashworth scale of elbow and shoulder joint Modified Tardieu scale of elbow and shoulder joint
measure: Medical research council scale of elbow and shoulder joint strength
time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
measure: Painless range of motion of elbow and shoulder joint
time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
measure: numeric rating scale of pain of elbow and shoulder joint
time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
measure: Associated reaction rating scale
time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
measure: surface electromyography data from bilateral upper extremities
time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
measure: Behavioral activation system/behavioral inhition system scale
time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
description: In terms of motivation
measure: Controlled Oral Word Association Test
time frame: baseline, 5ays of Inmotion, 20 days of Inmotion
description: Controlled Oral Word Association Test during baseline, 5 days of Inmotion, 20 days of Inmotion.
The test was done at rest and with Inmotion trial
measure: Fugl-Meyer Assessment
time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
measure: Stroke impact scale
time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
measure: Beck's depression index
time frame: baseline, 4 weeks, 8 weeks, and 12 weeks from baseline
measure: Satisfaction about the intervention
time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
measure: Adverse event
time frame: From baseline to 12 weeks from the baseline
measure: Digit span test
time frame: baseline, 5days after Inmotion, 20 days after Inmotion.
description: Digit span test(forward, backward) during baseline, 5 days of Inmotion, 20 days of Inmotion.
The test was done at rest and with Inmotion trial
arm group label: Early Inmotion and Botox
arm group type: Experimental
description: Concomitant use of Inmotion and botulinum toxin from the baseline
arm group label: Botox, then Inmotion
arm group type: Active Comparator
description: Inmotion training 4 weeks after botulinum toxin injection
arm group label: Inmotion, then Botox
arm group type: Active Comparator
description: From the baseline Inmotion, then Botox injection at 4 weeks after baseline
arm group label: Late Inmotion and Botox
arm group type: Active Comparator
description: No intervention, then Inmotion and Botox injection at 4 weeks from the baseline
intervention type: Other
intervention name: Early Inmotion and Botox
description: Concomitant use of Inmotion and Botox from the baseline
arm group label: Early Inmotion and Botox
intervention type: Other
intervention name: Botox, then Inmotion
description: At baseline Botox injection and 4 weeks after Inmotion
arm group label: Botox, then Inmotion
intervention type: Other
intervention name: Inmotion, then Botox
description: Inmotion from the baseline, then Botox injection at 4 weeks after baseline
arm group label: Inmotion, then Botox
intervention type: Other
intervention name: Late Inmotion and Botox
description: No intervention until 4 weeks from the baseline. Then Inmotion and Botox injection
arm group label: Late Inmotion and Botox
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joon-Ho Shin, MS
role: Principal Investigator
affiliation: National Rehabilitation Center
last name: Joon-Ho Shin, MS
phone: 82-2-901-1884
email: asfreelyas@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
url: http://nrc.go.kr
description: Site of the present study
responsible party type: Principal Investigator
investigator affiliation: National Rehabilitation Center, Seoul, Korea
investigator full name: Joon-Ho Shin
investigator title: Team manager
mesh term: Muscle Spasticity
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA