Effects of PlayStation®VR on the HRQOL in Stroke Patients Undergoing Inpatient Rehabilitation

Study Overview
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Brief Summary
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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.

Official Title
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Effects of PlayStation®VR on the Health-Related Quality of Life in Stroke Patients Undergoing Inpatient Rehabilitation: a Pilot Study

Conditions
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Stroke

Intervention / Treatment
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* Device: PlayStation®VR training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>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. | Device: PlayStation®VR training<br>* 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.<br>|
| No Intervention: Control group<br>Participants in the control group receive conventional rehabilitation therapy over 50 minutes on weekdays. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke Impact Scale (SIS) 3.0 Questionnaire | Health-Related Quality of Life | Baseline (Pre-intervention at 2 days after enrollment) | 
| Post-Intervention Change of Stroke Impact Scale (SIS) 3.0 Questionnaire | Post-intervention Health-Related Quality of Life | Change from baseline SIS scores at 18 days after enrollment | 
| 3-Month Follow-Up Change of Stroke Impact Scale (SIS) 3.0 Questionnaire | 3-month follow-up Health-Related Quality of Life | Change from baseline SIS scores at 92 days after enrollment | 
| Post-Intervention of Adverse Events or SAE | Proportion of intervention-related adverse events or SAE | 16 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motricity Index (MI) Upper Extremity Test | Motor impairment and function | Baseline (Pre-intervention) at 2 days after enrollment | 
| Post-Intervention Change of Motricity Index (MI) Upper Extremity Test | Post-intervention motor impairment and function | Change from baseline MI scores at 18 days after enrollment | 
| 3-Month Follow-Up Change of Motricity Index (MI) Upper Extremity Test | 3-month follow-up motor impairment and function | Change from baseline MI scores at 92 days after enrollment | 
| Fugl-Meyer Assessment for Upper Extremity (FMA-UE) | Motor impairment and function | Baseline (Pre-intervention) at 2 days after enrollment | 
| Post-Intervention Change of Fugl-Meyer Assessment for Upper Extremity (FMA-UE) | Post-intervention motor impairment and function | Change from baseline FMA-UE scores at 18 days after enrollment | 
| 3-Month Follow-Up Change of Fugl-Meyer Assessment for Upper Extremity (FMA-UE) | 3-month follow-up motor impairment and function | Change from baseline FMA-UE scores at 92 days after enrollment | 
| 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. | Baseline (Pre-intervention) at 2 days after enrollment | 
| 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. | Change from baseline self-care scores at 18 days after enrollment | 
| 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. | Change from baseline self-care scores at 92 days after enrollment | 
| 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. | Baseline (Pre-intervention) at 1 day after enrollment | 
| 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. | Change from baseline AMR scores at 19 days after enrollment | 
| 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. | Change from baseline AMR scores at 93 days after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Virtual Reality, Rehabilitation