<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/NCT04441177</url>
  </required_header>
  <id_info>
    <org_study_id>201801607A3</org_study_id>
    <nct_id>NCT04441177</nct_id>
  </id_info>
  <brief_title>Effects of PlayStation®VR on the HRQOL in Stroke Patients Undergoing Inpatient Rehabilitation</brief_title>
  <official_title>Effects of PlayStation®VR on the Health-Related Quality of Life in Stroke Patients Undergoing Inpatient Rehabilitation: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</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>
      Compared to conventional rehabilitation therapy, the full-immersive commercial game (CG)&#xD;
      system, in the form of available video game, could safely provide more positive effect on&#xD;
      health-related quality of life (HRQOL) and motor function in post-stroke patients.&#xD;
&#xD;
      The study aims to perform the research from 2019/7/1 to 2021/6/30 and enrolls a total of 80&#xD;
      participants. Stroke participants are recruited from the rehabilitation ward of CGMH&#xD;
      hospital.&#xD;
&#xD;
      The inclusion criteria are (a) first-time unilateral cerebral stroke, (b) stroke onset less&#xD;
      or equal to 1 year, (c) admission to the rehabilitation ward, (d) ages 20-80 years, (e)&#xD;
      spasticity of paretic arm ≤ grade 2 in the Modified Ashworth Scale, and (f) no active medical&#xD;
      problems such as fever, pneumonia, or scabies. The exclusion criteria are (a) brainstem or&#xD;
      cerebellar stroke, (b) epilepsy history, including photosensitive epilepsy, (c) previous or&#xD;
      active heart diseases, such as myocardial infarction or angina, (d) visuospatial problems&#xD;
      related to stroke, such as hemianopia or hemineglect, (e) paretic upper limb reaches&#xD;
      Brunnstrom recovery stage VI, (f) severe aphasia, (g) severe cognitive impairment, and (h)&#xD;
      poor cooperation with assessments.&#xD;
&#xD;
      All participants are randomly allocated to study group and control group. Participants in the&#xD;
      control group receive conventional rehabilitation therapy over 50 minutes on weekdays.&#xD;
      Participants in the study group receive conventional rehabilitation therapy over 50 minutes&#xD;
      on weekdays and 7 sessions (flexible schedule in different day) of PlayStation®VR of 20&#xD;
      minutes each in the main 16-day study period. Pre-intervention, post-intervention, and&#xD;
      3-month follow-up HRQOL will be assessed by the Stroke Impact Scale 3.0. Motricity Index and&#xD;
      Fugl-Meyer Assessment, Functional Independence Measure, and arm movement ratio will also be&#xD;
      checked before intervention, after intervention, and at 3-month follow-up. The safety&#xD;
      outcome, intervention-related adverse events or any serious adverse events, during study&#xD;
      period will be recorded.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">July 29, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 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>
    <intervention_model_description>All participants are randomly allocated to study group and control group. Each participant's main study period is set as 16 days with additional follow-up time at post-intervention 3 months. Participants in the control group receive conventional rehabilitation therapy over 50 minutes on weekdays. Participants in the study group receive conventional rehabilitation therapy over 50 minutes on weekdays and 7 sessions (flexible schedule in different day) of PlayStation®VR of 20 minutes each in the main 16-day study period.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Pre-intervention, post-intervention, and 3-month follow-up HRQOL will be assessed by the Stroke Impact Scale (SIS) 3.0. Motricity Index (MI) and Fugl-Meyer Assessment (FMA), Functional Independence Measure (FIM), and arm movement ratio (AMR) will also be checked before intervention, after intervention, and at 3-month follow-up. One blinded occupational therapist will evaluate the outcomes.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Stroke Impact Scale (SIS) 3.0 Questionnaire</measure>
    <time_frame>Baseline (Pre-intervention at 2 days after enrollment)</time_frame>
    <description>Health-Related Quality of Life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-Intervention Change of Stroke Impact Scale (SIS) 3.0 Questionnaire</measure>
    <time_frame>Change from baseline SIS scores at 18 days after enrollment</time_frame>
    <description>Post-intervention Health-Related Quality of Life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>3-Month Follow-Up Change of Stroke Impact Scale (SIS) 3.0 Questionnaire</measure>
    <time_frame>Change from baseline SIS scores at 92 days after enrollment</time_frame>
    <description>3-month follow-up Health-Related Quality of Life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-Intervention of Adverse Events or SAE</measure>
    <time_frame>16 days</time_frame>
    <description>Proportion of intervention-related adverse events or SAE</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Motricity Index (MI) Upper Extremity Test</measure>
    <time_frame>Baseline (Pre-intervention) at 2 days after enrollment</time_frame>
    <description>Motor impairment and function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-Intervention Change of Motricity Index (MI) Upper Extremity Test</measure>
    <time_frame>Change from baseline MI scores at 18 days after enrollment</time_frame>
    <description>Post-intervention motor impairment and function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-Month Follow-Up Change of Motricity Index (MI) Upper Extremity Test</measure>
    <time_frame>Change from baseline MI scores at 92 days after enrollment</time_frame>
    <description>3-month follow-up motor impairment and function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fugl-Meyer Assessment for Upper Extremity (FMA-UE)</measure>
    <time_frame>Baseline (Pre-intervention) at 2 days after enrollment</time_frame>
    <description>Motor impairment and function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-Intervention Change of Fugl-Meyer Assessment for Upper Extremity (FMA-UE)</measure>
    <time_frame>Change from baseline FMA-UE scores at 18 days after enrollment</time_frame>
    <description>Post-intervention motor impairment and function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-Month Follow-Up Change of Fugl-Meyer Assessment for Upper Extremity (FMA-UE)</measure>
    <time_frame>Change from baseline FMA-UE scores at 92 days after enrollment</time_frame>
    <description>3-month follow-up motor impairment and function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Care in Functional Independence Measure (FIM) Instrument</measure>
    <time_frame>Baseline (Pre-intervention) at 2 days after enrollment</time_frame>
    <description>The FIM is an 18-item instrument measuring a person's level of disability in terms of burden of care in six areas including self-care, continence, mobility, transfers, communication, and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1 = total assistance required, 7 = complete independence). Six items (eating, grooming, bathing, dressing upper body, dressing lower body, and toileting) of self care will be scored and summed in this study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-Intervention Change of Self-Care in Functional Independence Measure (FIM) Instrument</measure>
    <time_frame>Change from baseline self-care scores at 18 days after enrollment</time_frame>
    <description>The FIM is an 18-item instrument measuring a person's level of disability in terms of burden of care in six areas including self-care, continence, mobility, transfers, communication, and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1 = total assistance required, 7 = complete independence). Six items (eating, grooming, bathing, dressing upper body, dressing lower body, and toileting) of self care will be scored and summed in this study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-Month Follow-Up Change of Self-Care in Functional Independence Measure (FIM) Instrument</measure>
    <time_frame>Change from baseline self-care scores at 92 days after enrollment</time_frame>
    <description>The FIM is an 18-item instrument measuring a person's level of disability in terms of burden of care in six areas including self-care, continence, mobility, transfers, communication, and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1 = total assistance required, 7 = complete independence). Six items (eating, grooming, bathing, dressing upper body, dressing lower body, and toileting) of self care will be scored and summed in this study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arm Movement Ratio (AMR) Test</measure>
    <time_frame>Baseline (Pre-intervention) at 1 day after enrollment</time_frame>
    <description>The AMR, the ratio of arm use duration between the more and less affected arm, is detected and calculated by an accelerometer. The participants are asked to wear one accelerometer (ActiGraph wGT3x-BT, ActiGraph, LLC., Pensacola, FL, USA) on each arm for 7 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-Intervention Change of Arm Movement Ratio (AMR) Test</measure>
    <time_frame>Change from baseline AMR scores at 19 days after enrollment</time_frame>
    <description>The AMR, the ratio of arm use duration between the more and less affected arm, is detected and calculated by an accelerometer. The participants are asked to wear one accelerometer (ActiGraph wGT3x-BT, ActiGraph, LLC., Pensacola, FL, USA) on each arm for 7 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-Month Follow-Up Change of Arm Movement Ratio (AMR) Test</measure>
    <time_frame>Change from baseline AMR scores at 93 days after enrollment</time_frame>
    <description>The AMR, the ratio of arm use duration between the more and less affected arm, is detected and calculated by an accelerometer. The participants are asked to wear one accelerometer (ActiGraph wGT3x-BT, ActiGraph, LLC., Pensacola, FL, USA) on each arm for 7 hours.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the study group receive conventional rehabilitation therapy over 50 minutes on weekdays and 7 sessions (flexible schedule in different day) of PlayStation®VR of 20 minutes each in the main 16-day study period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control group receive conventional rehabilitation therapy over 50 minutes on weekdays.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PlayStation®VR training</intervention_name>
    <description>Participants in the study group receive conventional rehabilitation therapy over 50 minutes on weekdays and 7 sessions (flexible schedule in different day) of PlayStation®VR of 20 minutes each in the main 16-day study period.</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first-time unilateral cerebral stroke&#xD;
&#xD;
          -  stroke onset less or equal to 1 year&#xD;
&#xD;
          -  admission to the rehabilitation ward&#xD;
&#xD;
          -  ages 20-80 years&#xD;
&#xD;
          -  spasticity of paretic arm ≤ grade 2 in the Modified Ashworth Scale&#xD;
&#xD;
          -  no active medical problems such as fever, pneumonia, or scabies&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  brainstem or cerebellar stroke&#xD;
&#xD;
          -  epilepsy history, including photosensitive epilepsy&#xD;
&#xD;
          -  previous or active heart diseases, such as myocardial infarction or angina&#xD;
&#xD;
          -  visuospatial problems related to stroke, such as hemianopia or hemineglect&#xD;
&#xD;
          -  paretic upper limb reaches Brunnstrom recovery stage VI&#xD;
&#xD;
          -  severe aphasia&#xD;
&#xD;
          -  severe cognitive impairment&#xD;
&#xD;
          -  poor cooperation with assessments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chien-Min Chen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chiayi Chang Gung Memorial Hospital</name>
      <address>
        <city>Pozi</city>
        <zip>613</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Chien-Min Chen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Virtual Reality</keyword>
  <keyword>Rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT04441177
org study id: 201801607A3
nct id: NCT04441177
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Compared to conventional rehabilitation therapy, the full-immersive commercial game (CG)
      system, in the form of available video game, could safely provide more positive effect on
      health-related quality of life (HRQOL) and motor function in post-stroke patients.

      The study aims to perform the research from 2019/7/1 to 2021/6/30 and enrolls a total of 80
      participants. Stroke participants are recruited from the rehabilitation ward of CGMH
      hospital.

      The inclusion criteria are (a) first-time unilateral cerebral stroke, (b) stroke onset less
      or equal to 1 year, (c) admission to the rehabilitation ward, (d) ages 20-80 years, (e)
      spasticity of paretic arm ≤ grade 2 in the Modified Ashworth Scale, and (f) no active medical
      problems such as fever, pneumonia, or scabies. The exclusion criteria are (a) brainstem or
      cerebellar stroke, (b) epilepsy history, including photosensitive epilepsy, (c) previous or
      active heart diseases, such as myocardial infarction or angina, (d) visuospatial problems
      related to stroke, such as hemianopia or hemineglect, (e) paretic upper limb reaches
      Brunnstrom recovery stage VI, (f) severe aphasia, (g) severe cognitive impairment, and (h)
      poor cooperation with assessments.

      All participants are randomly allocated to study group and control group. Participants in the
      control group receive conventional rehabilitation therapy over 50 minutes on weekdays.
      Participants in the study group receive conventional rehabilitation therapy over 50 minutes
      on weekdays and 7 sessions (flexible schedule in different day) of PlayStation®VR of 20
      minutes each in the main 16-day study period. Pre-intervention, post-intervention, and
      3-month follow-up HRQOL will be assessed by the Stroke Impact Scale 3.0. Motricity Index and
      Fugl-Meyer Assessment, Functional Independence Measure, and arm movement ratio will also be
      checked before intervention, after intervention, and at 3-month follow-up. The safety
      outcome, intervention-related adverse events or any serious adverse events, during study
      period will be recorded.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: All participants are randomly allocated to study group and control group. Each participant's main study period is set as 16 days with additional follow-up time at post-intervention 3 months. Participants in the control group receive conventional rehabilitation therapy over 50 minutes on weekdays. Participants in the study group receive conventional rehabilitation therapy over 50 minutes on weekdays and 7 sessions (flexible schedule in different day) of PlayStation®VR of 20 minutes each in the main 16-day study period.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Pre-intervention, post-intervention, and 3-month follow-up HRQOL will be assessed by the Stroke Impact Scale (SIS) 3.0. Motricity Index (MI) and Fugl-Meyer Assessment (FMA), Functional Independence Measure (FIM), and arm movement ratio (AMR) will also be checked before intervention, after intervention, and at 3-month follow-up. One blinded occupational therapist will evaluate the outcomes.
measure: Stroke Impact Scale (SIS) 3.0 Questionnaire
time frame: Baseline (Pre-intervention at 2 days after enrollment)
description: Health-Related Quality of Life
measure: Post-Intervention Change of Stroke Impact Scale (SIS) 3.0 Questionnaire
time frame: Change from baseline SIS scores at 18 days after enrollment
description: Post-intervention Health-Related Quality of Life
measure: 3-Month Follow-Up Change of Stroke Impact Scale (SIS) 3.0 Questionnaire
time frame: Change from baseline SIS scores at 92 days after enrollment
description: 3-month follow-up Health-Related Quality of Life
measure: Post-Intervention of Adverse Events or SAE
time frame: 16 days
description: Proportion of intervention-related adverse events or SAE
measure: Motricity Index (MI) Upper Extremity Test
time frame: Baseline (Pre-intervention) at 2 days after enrollment
description: Motor impairment and function
measure: Post-Intervention Change of Motricity Index (MI) Upper Extremity Test
time frame: Change from baseline MI scores at 18 days after enrollment
description: Post-intervention motor impairment and function
measure: 3-Month Follow-Up Change of Motricity Index (MI) Upper Extremity Test
time frame: Change from baseline MI scores at 92 days after enrollment
description: 3-month follow-up motor impairment and function
measure: Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
time frame: Baseline (Pre-intervention) at 2 days after enrollment
description: Motor impairment and function
measure: Post-Intervention Change of Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
time frame: Change from baseline FMA-UE scores at 18 days after enrollment
description: Post-intervention motor impairment and function
measure: 3-Month Follow-Up Change of Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
time frame: Change from baseline FMA-UE scores at 92 days after enrollment
description: 3-month follow-up motor impairment and function
measure: Self-Care in Functional Independence Measure (FIM) Instrument
time frame: Baseline (Pre-intervention) at 2 days after enrollment
description: The FIM is an 18-item instrument measuring a person's level of disability in terms of burden of care in six areas including self-care, continence, mobility, transfers, communication, and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1 = total assistance required, 7 = complete independence). Six items (eating, grooming, bathing, dressing upper body, dressing lower body, and toileting) of self care will be scored and summed in this study.
measure: Post-Intervention Change of Self-Care in Functional Independence Measure (FIM) Instrument
time frame: Change from baseline self-care scores at 18 days after enrollment
description: The FIM is an 18-item instrument measuring a person's level of disability in terms of burden of care in six areas including self-care, continence, mobility, transfers, communication, and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1 = total assistance required, 7 = complete independence). Six items (eating, grooming, bathing, dressing upper body, dressing lower body, and toileting) of self care will be scored and summed in this study.
measure: 3-Month Follow-Up Change of Self-Care in Functional Independence Measure (FIM) Instrument
time frame: Change from baseline self-care scores at 92 days after enrollment
description: The FIM is an 18-item instrument measuring a person's level of disability in terms of burden of care in six areas including self-care, continence, mobility, transfers, communication, and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1 = total assistance required, 7 = complete independence). Six items (eating, grooming, bathing, dressing upper body, dressing lower body, and toileting) of self care will be scored and summed in this study.
measure: Arm Movement Ratio (AMR) Test
time frame: Baseline (Pre-intervention) at 1 day after enrollment
description: The AMR, the ratio of arm use duration between the more and less affected arm, is detected and calculated by an accelerometer. The participants are asked to wear one accelerometer (ActiGraph wGT3x-BT, ActiGraph, LLC., Pensacola, FL, USA) on each arm for 7 hours.
measure: Post-Intervention Change of Arm Movement Ratio (AMR) Test
time frame: Change from baseline AMR scores at 19 days after enrollment
description: The AMR, the ratio of arm use duration between the more and less affected arm, is detected and calculated by an accelerometer. The participants are asked to wear one accelerometer (ActiGraph wGT3x-BT, ActiGraph, LLC., Pensacola, FL, USA) on each arm for 7 hours.
measure: 3-Month Follow-Up Change of Arm Movement Ratio (AMR) Test
time frame: Change from baseline AMR scores at 93 days after enrollment
description: The AMR, the ratio of arm use duration between the more and less affected arm, is detected and calculated by an accelerometer. The participants are asked to wear one accelerometer (ActiGraph wGT3x-BT, ActiGraph, LLC., Pensacola, FL, USA) on each arm for 7 hours.
arm group label: Study group
arm group type: Experimental
description: Participants in the study group receive conventional rehabilitation therapy over 50 minutes on weekdays and 7 sessions (flexible schedule in different day) of PlayStation®VR of 20 minutes each in the main 16-day study period.
arm group label: Control group
arm group type: No Intervention
description: Participants in the control group receive conventional rehabilitation therapy over 50 minutes on weekdays.
intervention type: Device
intervention name: PlayStation®VR training
description: Participants in the study group receive conventional rehabilitation therapy over 50 minutes on weekdays and 7 sessions (flexible schedule in different day) of PlayStation®VR of 20 minutes each in the main 16-day study period.
arm group label: Study group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Chien-Min Chen, MD
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: Chien-Min Chen
investigator title: Principal Investigator
mesh term: Stroke
sharing ipd: No