<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/NCT03277950</url>
  </required_header>
  <id_info>
    <org_study_id>2016/097.0906</org_study_id>
    <nct_id>NCT03277950</nct_id>
  </id_info>
  <brief_title>Effect of Virtual Reality Game on Upper Limb Movement in Individuals With Stroke</brief_title>
  <acronym>VRULS</acronym>
  <official_title>Effect of Game-based Virtual Reality Training on Upper Extremity Movement in Individuals With Subacute Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vimonwan Hiengkaew</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol 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>
      Individuals with stroke show abnormal movement pattern of upper limb. The movement pattern&#xD;
      needs to be corrected. There are several methods to train normal movement. Exercise with&#xD;
      technology is an active movement and affects sensory and cognitive systems. It may benefit to&#xD;
      individuals with stroke in training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Individuals with stroke sign informed consent. They are trained with virtual reality game&#xD;
      with and without feedback from a researcher. Age-matched healthy play the same game as&#xD;
      individuals with stroke do. Both individuals with stroke and healthy are measured upper limb&#xD;
      movement pattern.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 15, 2017</start_date>
  <completion_date type="Anticipated">September 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 15, 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>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>kinematic data</measure>
    <time_frame>10 minutes</time_frame>
    <description>angle of shoulder, elbow, and forearm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Upper limb performance</measure>
    <time_frame>10 minutes</time_frame>
    <description>doing task according to Fugl Mayer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>muscle tone</measure>
    <time_frame>2 minutes</time_frame>
    <description>assessing muscles of shoulder, elbow, and forearm according to Modified Ashworth Scale</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">21</enrollment>
  <condition>Stroke</condition>
  <condition>Movement, Abnormal</condition>
  <arm_group>
    <arm_group_label>virtual reality with feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received training via virtual reality game with feedback, 60 minutes/day, 3 days/week for 4 weeks, then follow up after 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>virtual reality without feedback</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants received training via virtual reality game without feedback, 60 minutes/day, 3 days/week for 4 weeks, then follow up after 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants do not play virtual reality game.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Virtual reality with feedback</intervention_name>
    <description>Individuals with stroke play game with correction of movement.</description>
    <arm_group_label>virtual reality with feedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Virtual reality without feedback</intervention_name>
    <description>Individuals with stroke play game without correction of movement.</description>
    <arm_group_label>virtual reality without feedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Healthy</intervention_name>
    <description>Healthy do not play game</description>
    <arm_group_label>Healthy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Individuals with stroke&#xD;
&#xD;
          1. 45 - 65 years old&#xD;
&#xD;
          2. First ischemic or hemorrhagic stroke&#xD;
&#xD;
          3. Right hemiparesis&#xD;
&#xD;
          4. Right dominant handedness&#xD;
&#xD;
          5. Within 6 months after stroke&#xD;
&#xD;
          6. Discharge from hospital and stay at home&#xD;
&#xD;
          7. Normal dynamic sitting balance&#xD;
&#xD;
          8. At least 120 degrees of shoulder flexion and 45 degrees of shoulder extension by&#xD;
             passive range of motion&#xD;
&#xD;
          9. Active movement at least stage 3 by Chedoke-McMaster Stroke Assessment&#xD;
&#xD;
         10. Muscle tone graded 1-2 by Modified Ashworth Scale in 2 of 3 muscle groups including&#xD;
             shoulder adductor, internal rotator or/and elbow flexor groups&#xD;
&#xD;
         11. No cognitive impairment&#xD;
&#xD;
        Healthy individuals&#xD;
&#xD;
          1. Have same gender and age within range of ±5 years of individuals with stroke&#xD;
&#xD;
          2. Right handedness&#xD;
&#xD;
          3. Active range of motion of shoulder flexion and extension at least 120°and 45°&#xD;
             respectively&#xD;
&#xD;
          4. No cognitive impairment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Individual with stroke and healthy&#xD;
&#xD;
          1. Have cyber-sickness&#xD;
&#xD;
          2. Obesity&#xD;
&#xD;
          3. Ataxic movement&#xD;
&#xD;
          4. Loss visual field or visual neglect&#xD;
&#xD;
          5. Loss exteroceptive sensation&#xD;
&#xD;
          6. Impaired or loss proprioceptive sensation&#xD;
&#xD;
          7. Receive the occupation therapy on upper extremity&#xD;
&#xD;
          8. Muscle contracture at the scapula, shoulder and elbow&#xD;
&#xD;
          9. Pain at the scapula, shoulder and elbow&#xD;
&#xD;
         10. History of fracture or surgery at head, shoulder, scapula, and elbow&#xD;
&#xD;
         11. Shoulder subluxation&#xD;
&#xD;
         12. Other neurological disorders&#xD;
&#xD;
         13. Uncontrolled hypertension&#xD;
&#xD;
         14. Myocardial infarction&#xD;
&#xD;
         15. Seizure or epilepsy&#xD;
&#xD;
         16. Pacemaker or hemodialysis vascular access&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vimonwan Hiengkaew, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Mahidol University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peemonkong Wattananon, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Mahidol University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sirada Lolak, BSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mahidol University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vimonwan Hiengkaew, PhD</last_name>
    <phone>+6624415450</phone>
    <email>vimonwan.hie@mahidol.ac.th</email>
  </overall_contact>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>September 8, 2017</last_update_submitted>
  <last_update_submitted_qc>September 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mahidol University</investigator_affiliation>
    <investigator_full_name>Vimonwan Hiengkaew</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>virtual reality</keyword>
  <keyword>feedback</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Dyskinesias</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/NCT03277950
org study id: 2016/097.0906
nct id: NCT03277950
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Individuals with stroke show abnormal movement pattern of upper limb. The movement pattern
      needs to be corrected. There are several methods to train normal movement. Exercise with
      technology is an active movement and affects sensory and cognitive systems. It may benefit to
      individuals with stroke in training.
Individuals with stroke sign informed consent. They are trained with virtual reality game
      with and without feedback from a researcher. Age-matched healthy play the same game as
      individuals with stroke do. Both individuals with stroke and healthy are measured upper limb
      movement pattern.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: kinematic data
time frame: 10 minutes
description: angle of shoulder, elbow, and forearm
measure: Upper limb performance
time frame: 10 minutes
description: doing task according to Fugl Mayer
measure: muscle tone
time frame: 2 minutes
description: assessing muscles of shoulder, elbow, and forearm according to Modified Ashworth Scale
arm group label: virtual reality with feedback
arm group type: Experimental
description: Participants received training via virtual reality game with feedback, 60 minutes/day, 3 days/week for 4 weeks, then follow up after 4 weeks.
arm group label: virtual reality without feedback
arm group type: Active Comparator
description: Participants received training via virtual reality game without feedback, 60 minutes/day, 3 days/week for 4 weeks, then follow up after 4 weeks.
arm group label: Healthy
arm group type: Other
description: Participants do not play virtual reality game.
intervention type: Other
intervention name: Virtual reality with feedback
description: Individuals with stroke play game with correction of movement.
arm group label: virtual reality with feedback
intervention type: Other
intervention name: Virtual reality without feedback
description: Individuals with stroke play game without correction of movement.
arm group label: virtual reality without feedback
intervention type: Other
intervention name: Healthy
description: Healthy do not play game
arm group label: Healthy
criteria: 
gender: All
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Vimonwan Hiengkaew, PhD
role: Study Chair
affiliation: Mahidol University
last name: Peemonkong Wattananon, PhD
role: Study Director
affiliation: Mahidol University
last name: Sirada Lolak, BSc
role: Principal Investigator
affiliation: Mahidol University
last name: Vimonwan Hiengkaew, PhD
phone: +6624415450
email: vimonwan.hie@mahidol.ac.th
responsible party type: Sponsor-Investigator
investigator affiliation: Mahidol University
investigator full name: Vimonwan Hiengkaew
investigator title: Associate professor
mesh term: Stroke
mesh term: Dyskinesias
sharing ipd: No