<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/NCT03005457</url>
  </required_header>
  <id_info>
    <org_study_id>60047824</org_study_id>
    <nct_id>NCT03005457</nct_id>
  </id_info>
  <brief_title>Pilot Study to Assess the Feasibility and Initial Efficacy of Therapist-as-consultant, Game-based CI Therapy</brief_title>
  <official_title>A Low-cost Virtual Reality Gaming Platform for Neurorehabilitation of Hemiparesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nationwide Children</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pilot study to assess the feasibility and initial efficacy of therapist-as-consultant,&#xD;
      game-based CI therapy. Pre/post study design. Participant received a target of 30 hours&#xD;
      game-based motor intervention, 100 hours constraint of the less affected upper extremity, and&#xD;
      5 hours therapist consultation (including completion of a behavioral contract at the first&#xD;
      study visit). Duration of intervention was 10 consecutive weekdays, with pre-treatment and&#xD;
      post-treatment testing performed within 1 week prior to and 1 week post-intervention by an&#xD;
      independent tester.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Motor Activity Log</measure>
    <time_frame>Week 0 and Week 3</time_frame>
    <description>Self-report measure of arm use for daily activities</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Wolf Motor Function Test</measure>
    <time_frame>Week 0 and Week 3</time_frame>
    <description>Objective measure of motor function in a laboratory setting</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Kinematic Data</measure>
    <time_frame>Week 0 and Week 3</time_frame>
    <description>Kinematic data recorded during game play</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Kinesthesia test</measure>
    <time_frame>Week 0 and Week 3</time_frame>
    <description>Clinical Assessment of sensation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire</measure>
    <time_frame>Week 0 and Week 3</time_frame>
    <description>Measures Depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strok Specific Quality of Life Scale</measure>
    <time_frame>Week 0 and Week 3</time_frame>
    <description>Quality of life measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weschler Adult Intelligence Scale Symbol Seach</measure>
    <time_frame>Week 0 and Week 3</time_frame>
    <description>Cognitive processing speed assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Montreal Cognitive Assessment</measure>
    <time_frame>Week 0 and Week 3</time_frame>
    <description>Baseline cognitive screen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survey</measure>
    <time_frame>Week 0 and Week 3</time_frame>
    <description>Survey on satisfaction with the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mitt Compliance</measure>
    <time_frame>Week 0 and Week 3</time_frame>
    <description>Hours of use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total game-play time</measure>
    <time_frame>Week 0 and Week 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gestures</measure>
    <time_frame>Week 0 and Week 3</time_frame>
    <description>Number of gestures of each type registered in game</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bilateral activity monitors</measure>
    <time_frame>Week 0 and Week 3</time_frame>
    <description>Objective measure of arm use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Action Research Arm Test (ARAT)</measure>
    <time_frame>Week 0 and Week 3</time_frame>
    <description>Asses Changes in Limb Function</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Stroke</condition>
  <condition>Hemiparesis</condition>
  <condition>Upper Extremity Dysfunction</condition>
  <arm_group>
    <arm_group_label>Stroke</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Hemiparesis other</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Hemiparesis Therapy with VR</intervention_name>
    <description>An in-home therapist-as-consultant model of CI therapy in which motor practice with shaping and the Motor Activity Log with problem solving were delivered via a custom avatar-based video game called Recovery Rapids</description>
    <arm_group_label>Hemiparesis other</arm_group_label>
    <arm_group_label>Stroke</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provide signed and dated informed consent form&#xD;
&#xD;
          -  Willing to comply with all study procedures and be available for the duration of the&#xD;
             study&#xD;
&#xD;
          -  Male or female aged &gt; 17&#xD;
&#xD;
          -  Preserved ability to comprehend English and participate in basic elements of the&#xD;
             therapy&#xD;
&#xD;
          -  Community-dwelling&#xD;
&#xD;
          -  Experienced mild to moderate hemiparesis at least six months prior&#xD;
&#xD;
          -  Can independently operate the gaming system (those with severe cognitive impairments&#xD;
             can usually achieve this)&#xD;
&#xD;
          -  Corrected vision of at least 20/70 as assessed by their ability to identify game&#xD;
             objects on the monitor from 5 feet away&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  concurrent participation in other experimental upper extremity trials&#xD;
&#xD;
          -  concurrent participation in other outpatient rehabilitation for their upper extremity&#xD;
&#xD;
          -  Botox within the last 3 months (confound)&#xD;
&#xD;
          -  near-normal motor function (9-hole Peg Test score above the 10th percentile of a&#xD;
             normative sample)&#xD;
&#xD;
          -  minimal nonuse (Motor Activity Log at baseline &gt;2.5, Accelerometry &gt; 60%)&#xD;
&#xD;
          -  major medical issues that would interfere with study treatments or make intensive&#xD;
             rehabilitation difficult to tolerate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Ohio State University, 2154 Dodd Hall</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>December 25, 2016</last_update_submitted>
  <last_update_submitted_qc>December 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Lynne Gauthier , PhD</investigator_full_name>
    <investigator_title>Assistant Prof. PM&amp;R</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paresis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Will be shared upon publication acceptance.</ipd_description>
  </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/NCT03005457
org study id: 60047824
nct id: NCT03005457
lead sponsor: 
collaborator: 
has dmc: No
Pilot study to assess the feasibility and initial efficacy of therapist-as-consultant,
      game-based CI therapy. Pre/post study design. Participant received a target of 30 hours
      game-based motor intervention, 100 hours constraint of the less affected upper extremity, and
      5 hours therapist consultation (including completion of a behavioral contract at the first
      study visit). Duration of intervention was 10 consecutive weekdays, with pre-treatment and
      post-treatment testing performed within 1 week prior to and 1 week post-intervention by an
      independent tester.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Motor Activity Log
time frame: Week 0 and Week 3
description: Self-report measure of arm use for daily activities
measure: Change in Wolf Motor Function Test
time frame: Week 0 and Week 3
description: Objective measure of motor function in a laboratory setting
measure: Kinematic Data
time frame: Week 0 and Week 3
description: Kinematic data recorded during game play
measure: Brief Kinesthesia test
time frame: Week 0 and Week 3
description: Clinical Assessment of sensation
measure: Patient Health Questionnaire
time frame: Week 0 and Week 3
description: Measures Depression
measure: Strok Specific Quality of Life Scale
time frame: Week 0 and Week 3
description: Quality of life measurement
measure: Weschler Adult Intelligence Scale Symbol Seach
time frame: Week 0 and Week 3
description: Cognitive processing speed assessment
measure: Montreal Cognitive Assessment
time frame: Week 0 and Week 3
description: Baseline cognitive screen
measure: Survey
time frame: Week 0 and Week 3
description: Survey on satisfaction with the intervention
measure: Mitt Compliance
time frame: Week 0 and Week 3
description: Hours of use
measure: Total game-play time
time frame: Week 0 and Week 3
measure: Gestures
time frame: Week 0 and Week 3
description: Number of gestures of each type registered in game
measure: Bilateral activity monitors
time frame: Week 0 and Week 3
description: Objective measure of arm use
measure: Action Research Arm Test (ARAT)
time frame: Week 0 and Week 3
description: Asses Changes in Limb Function
arm group label: Stroke
arm group type: Experimental
arm group label: Hemiparesis other
arm group type: Experimental
intervention type: Behavioral
intervention name: Hemiparesis Therapy with VR
description: An in-home therapist-as-consultant model of CI therapy in which motor practice with shaping and the Motor Activity Log with problem solving were delivered via a custom avatar-based video game called Recovery Rapids
arm group label: Hemiparesis other
arm group label: Stroke
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Lynne Gauthier , PhD
investigator title: Assistant Prof. PM&R
mesh term: Paresis
sharing ipd: Yes
ipd description: Will be shared upon publication acceptance.