Effects of PlayStation®VR on the HRQOL in Stroke Patients Undergoing Inpatient Rehabilitation
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
PlayStation®VR training
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Virtual Reality, Rehabilitation
Eligibility Criteria
Inclusion Criteria:
- first-time unilateral cerebral stroke
- stroke onset less or equal to 1 year
- admission to the rehabilitation ward
- ages 20-80 years
- spasticity of paretic arm ≤ grade 2 in the Modified Ashworth Scale
- no active medical problems such as fever, pneumonia, or scabies
Exclusion Criteria:
- brainstem or cerebellar stroke
- epilepsy history, including photosensitive epilepsy
- previous or active heart diseases, such as myocardial infarction or angina
- visuospatial problems related to stroke, such as hemianopia or hemineglect
- paretic upper limb reaches Brunnstrom recovery stage VI
- severe aphasia
- severe cognitive impairment
- poor cooperation with assessments
Sites / Locations
- Chiayi Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Study group
Control group
Arm 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.
Participants in the control group receive conventional rehabilitation therapy over 50 minutes on weekdays.
Outcomes
Primary Outcome Measures
Stroke Impact Scale (SIS) 3.0 Questionnaire
Health-Related Quality of Life
Post-Intervention Change of Stroke Impact Scale (SIS) 3.0 Questionnaire
Post-intervention Health-Related Quality of Life
3-Month Follow-Up Change of Stroke Impact Scale (SIS) 3.0 Questionnaire
3-month follow-up Health-Related Quality of Life
Post-Intervention of Adverse Events or SAE
Proportion of intervention-related adverse events or SAE
Secondary Outcome Measures
Motricity Index (MI) Upper Extremity Test
Motor impairment and function
Post-Intervention Change of Motricity Index (MI) Upper Extremity Test
Post-intervention motor impairment and function
3-Month Follow-Up Change of Motricity Index (MI) Upper Extremity Test
3-month follow-up motor impairment and function
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Motor impairment and function
Post-Intervention Change of Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Post-intervention motor impairment and function
3-Month Follow-Up Change of Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
3-month follow-up motor impairment and function
Self-Care in Functional Independence Measure (FIM) Instrument
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.
Post-Intervention Change of Self-Care in Functional Independence Measure (FIM) Instrument
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.
3-Month Follow-Up Change of Self-Care in Functional Independence Measure (FIM) Instrument
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.
Arm Movement Ratio (AMR) Test
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.
Post-Intervention Change of Arm Movement Ratio (AMR) Test
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.
3-Month Follow-Up Change of Arm Movement Ratio (AMR) Test
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.
Full Information
NCT ID
NCT04441177
First Posted
June 16, 2020
Last Updated
June 19, 2020
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04441177
Brief Title
Effects of PlayStation®VR on the HRQOL in Stroke Patients Undergoing Inpatient Rehabilitation
Official Title
Effects of PlayStation®VR on the Health-Related Quality of Life in Stroke Patients Undergoing Inpatient Rehabilitation: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 29, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Virtual Reality, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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.
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm 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 Title
Control group
Arm Type
No Intervention
Arm Description
Participants in the control group receive conventional rehabilitation therapy over 50 minutes on weekdays.
Intervention Type
Device
Intervention Name(s)
PlayStation®VR training
Intervention 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.
Primary Outcome Measure Information:
Title
Stroke Impact Scale (SIS) 3.0 Questionnaire
Description
Health-Related Quality of Life
Time Frame
Baseline (Pre-intervention at 2 days after enrollment)
Title
Post-Intervention Change of Stroke Impact Scale (SIS) 3.0 Questionnaire
Description
Post-intervention Health-Related Quality of Life
Time Frame
Change from baseline SIS scores at 18 days after enrollment
Title
3-Month Follow-Up Change of Stroke Impact Scale (SIS) 3.0 Questionnaire
Description
3-month follow-up Health-Related Quality of Life
Time Frame
Change from baseline SIS scores at 92 days after enrollment
Title
Post-Intervention of Adverse Events or SAE
Description
Proportion of intervention-related adverse events or SAE
Time Frame
16 days
Secondary Outcome Measure Information:
Title
Motricity Index (MI) Upper Extremity Test
Description
Motor impairment and function
Time Frame
Baseline (Pre-intervention) at 2 days after enrollment
Title
Post-Intervention Change of Motricity Index (MI) Upper Extremity Test
Description
Post-intervention motor impairment and function
Time Frame
Change from baseline MI scores at 18 days after enrollment
Title
3-Month Follow-Up Change of Motricity Index (MI) Upper Extremity Test
Description
3-month follow-up motor impairment and function
Time Frame
Change from baseline MI scores at 92 days after enrollment
Title
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Description
Motor impairment and function
Time Frame
Baseline (Pre-intervention) at 2 days after enrollment
Title
Post-Intervention Change of Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Description
Post-intervention motor impairment and function
Time Frame
Change from baseline FMA-UE scores at 18 days after enrollment
Title
3-Month Follow-Up Change of Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Description
3-month follow-up motor impairment and function
Time Frame
Change from baseline FMA-UE scores at 92 days after enrollment
Title
Self-Care in Functional Independence Measure (FIM) Instrument
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.
Time Frame
Baseline (Pre-intervention) at 2 days after enrollment
Title
Post-Intervention Change of Self-Care in Functional Independence Measure (FIM) Instrument
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.
Time Frame
Change from baseline self-care scores at 18 days after enrollment
Title
3-Month Follow-Up Change of Self-Care in Functional Independence Measure (FIM) Instrument
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.
Time Frame
Change from baseline self-care scores at 92 days after enrollment
Title
Arm Movement Ratio (AMR) Test
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.
Time Frame
Baseline (Pre-intervention) at 1 day after enrollment
Title
Post-Intervention Change of Arm Movement Ratio (AMR) Test
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.
Time Frame
Change from baseline AMR scores at 19 days after enrollment
Title
3-Month Follow-Up Change of Arm Movement Ratio (AMR) Test
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.
Time Frame
Change from baseline AMR scores at 93 days after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
first-time unilateral cerebral stroke
stroke onset less or equal to 1 year
admission to the rehabilitation ward
ages 20-80 years
spasticity of paretic arm ≤ grade 2 in the Modified Ashworth Scale
no active medical problems such as fever, pneumonia, or scabies
Exclusion Criteria:
brainstem or cerebellar stroke
epilepsy history, including photosensitive epilepsy
previous or active heart diseases, such as myocardial infarction or angina
visuospatial problems related to stroke, such as hemianopia or hemineglect
paretic upper limb reaches Brunnstrom recovery stage VI
severe aphasia
severe cognitive impairment
poor cooperation with assessments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chien-Min Chen, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chiayi Chang Gung Memorial Hospital
City
Pozi
ZIP/Postal Code
613
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of PlayStation®VR on the HRQOL in Stroke Patients Undergoing Inpatient Rehabilitation
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