<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/NCT03270852</url>
  </required_header>
  <id_info>
    <org_study_id>chhwang8</org_study_id>
    <nct_id>NCT03270852</nct_id>
  </id_info>
  <brief_title>Enhanced Reality for Hemiparetic Arm in the Stroke Patients</brief_title>
  <official_title>Enhanced Reality for Hemiparetic Arm in the Stroke Patients; Randomized Case-controlled Clinical Trial for Efficacy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ulsan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ulsan University Hospital</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>
      The researchers found that enhanced reality developed for the first time in the word by us&#xD;
      had a synergistic or additive effect on brain plasticity in patients without central nervous&#xD;
      system injury. The aim of this study is to determine the validity and feasibility of enhanced&#xD;
      reality in hemiparetic arm in the stroke patients with central nervous system injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pre-interventional evaluation; within 1 day of initiation of the intervention; 10 days after&#xD;
      initiation of the intervention; 30 days after termination of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 13, 2019</start_date>
  <completion_date type="Anticipated">October 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2021</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>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Jebsen Taylor test</measure>
    <time_frame>1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment</time_frame>
    <description>Jebsen-Taylor Hand Function Test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Arm motor Fugl-Mayer scale</measure>
    <time_frame>1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment</time_frame>
    <description>Arm motor Fugl-Mayer scale; wrist &amp; hand/proximal arm</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change of Ashworth scale</measure>
    <time_frame>1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment</time_frame>
    <description>Ashworth scale; wrist/ elbow</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of 9-hole pegboard</measure>
    <time_frame>1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment</time_frame>
    <description>9-hole pegboard</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Stroke impact scale</measure>
    <time_frame>1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment</time_frame>
    <description>Stroke impact scale, hand function</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Grasp force in Newtons</measure>
    <time_frame>1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment</time_frame>
    <description>Grasp force in Newtons</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Active range of motion of wrist joint</measure>
    <time_frame>1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment</time_frame>
    <description>range of motion of the wrist joint</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Korean-modified Barthel index</measure>
    <time_frame>1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment</time_frame>
    <description>Korean version-Modified Barthel Index</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of motor evoked potential of abdutor pollicis brevis</measure>
    <time_frame>1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment</time_frame>
    <description>Motor Evoked Potential</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">38</enrollment>
  <condition>Stroke</condition>
  <condition>Paresis</condition>
  <condition>Mirror Movement</condition>
  <arm_group>
    <arm_group_label>Enhanced reality</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients are provided with occupational therapy and physical therapy (task-oriented OT 30 min, FES 20 min) daily for 50 minutes.&#xD;
ER therapy is provided 2 times a day for 10 minutes for 2 weeks (10 days of treatment week), except for time of installation, calibration, and 3 minute breaks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Enhanced reality</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients are provided with occupational therapy and physical therapy (task-oriented OT 30 min, FES 20 min) daily for 50 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Enhanced reality</intervention_name>
    <description>This prototype is developed by investigators for the first time so that it have no trademark or manufacturer name yet.&#xD;
The patient sits facing the horizontal desk with the ER therapy device, and then raises the wrist joint to the fixed base. The hand, wrist, and distal forearm to be treated are positioned below the ER medical camera so that the wrist is visible on the screen. Fix the wrist and wrist joint using Velcro. When treating the distal forearm, detach the wrist fixing Velcro.</description>
    <arm_group_label>Enhanced reality</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Enhanced reality</intervention_name>
    <description>Identical rehabilitation without enhanced reality</description>
    <arm_group_label>No Enhanced reality</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Arm motor Fugl-Mayer scale; wrist/hand subscales ≥ 2-20&#xD;
&#xD;
          -  9-hole pegboard ; ≥ 25% of contra-lateral hand&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Alexander apraxia scale ≤2&#xD;
&#xD;
          -  NIH stroke scale question Ia-c ≥1&#xD;
&#xD;
          -  Nottingham sensory scale; &lt;75% of contra-lateral hand&#xD;
&#xD;
          -  Ashworth scale ≥3&#xD;
&#xD;
          -  NIH stroke scale question IX ≥2&#xD;
&#xD;
          -  Beck depression inventory ≥21&#xD;
&#xD;
          -  Significant upper extremity disease causing hand or below elbow dysfunction&#xD;
&#xD;
          -  Visual disturbance&#xD;
&#xD;
          -  Refusal of participation&#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>Chang Ho Hwang, M.D., Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Ulsan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chang Ho Hwang</last_name>
    <phone>+82-52-250-7210</phone>
    <email>chhwang1220ciba@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ulsan University Hospital</name>
      <address>
        <city>Ulsan</city>
        <zip>682-714</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chang Ho Hwang, M.D., Ph.D.</last_name>
      <phone>+82-52-250-7210</phone>
      <email>chhwang1220ciba@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Chang Ho Hwang, M.D., Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>August 30, 2019</last_update_submitted>
  <last_update_submitted_qc>August 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ulsan University Hospital</investigator_affiliation>
    <investigator_full_name>Chang Ho Hwang</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Paresis</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/NCT03270852
org study id: chhwang8
nct id: NCT03270852
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The researchers found that enhanced reality developed for the first time in the word by us
      had a synergistic or additive effect on brain plasticity in patients without central nervous
      system injury. The aim of this study is to determine the validity and feasibility of enhanced
      reality in hemiparetic arm in the stroke patients with central nervous system injury.
Pre-interventional evaluation; within 1 day of initiation of the intervention; 10 days after
      initiation of the intervention; 30 days after termination of treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Change of Jebsen Taylor test
time frame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
description: Jebsen-Taylor Hand Function Test
measure: Change of Arm motor Fugl-Mayer scale
time frame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
description: Arm motor Fugl-Mayer scale; wrist & hand/proximal arm
measure: Change of Ashworth scale
time frame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
description: Ashworth scale; wrist/ elbow
measure: Change of 9-hole pegboard
time frame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
description: 9-hole pegboard
measure: Change of Stroke impact scale
time frame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
description: Stroke impact scale, hand function
measure: Change of Grasp force in Newtons
time frame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
description: Grasp force in Newtons
measure: Change of Active range of motion of wrist joint
time frame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
description: range of motion of the wrist joint
measure: Change of Korean-modified Barthel index
time frame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
description: Korean version-Modified Barthel Index
measure: Change of motor evoked potential of abdutor pollicis brevis
time frame: 1 day before the initiation of intervention, 10 day after the initiation of intervention, and 30 days after termination of treatment
description: Motor Evoked Potential
arm group label: Enhanced reality
arm group type: Experimental
description: Patients are provided with occupational therapy and physical therapy (task-oriented OT 30 min, FES 20 min) daily for 50 minutes.
ER therapy is provided 2 times a day for 10 minutes for 2 weeks (10 days of treatment week), except for time of installation, calibration, and 3 minute breaks.
arm group label: No Enhanced reality
arm group type: Active Comparator
description: Patients are provided with occupational therapy and physical therapy (task-oriented OT 30 min, FES 20 min) daily for 50 minutes.
intervention type: Device
intervention name: Enhanced reality
description: This prototype is developed by investigators for the first time so that it have no trademark or manufacturer name yet.
The patient sits facing the horizontal desk with the ER therapy device, and then raises the wrist joint to the fixed base. The hand, wrist, and distal forearm to be treated are positioned below the ER medical camera so that the wrist is visible on the screen. Fix the wrist and wrist joint using Velcro. When treating the distal forearm, detach the wrist fixing Velcro.
arm group label: Enhanced reality
intervention type: Other
intervention name: No Enhanced reality
description: Identical rehabilitation without enhanced reality
arm group label: No Enhanced reality
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chang Ho Hwang, M.D., Ph.D.
role: Study Director
affiliation: Ulsan University Hospital
last name: Chang Ho Hwang
phone: +82-52-250-7210
email: chhwang1220ciba@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Ulsan University Hospital
investigator full name: Chang Ho Hwang
investigator title: Principal Investigator
mesh term: Stroke
mesh term: Paresis
sharing ipd: No