Effects of PlayStation®VR on the HRQOL in Stroke Patients Undergoing Inpatient Rehabilitation
Keywords
Abstract
Dates
| Last Verified: | 05/31/2020 |
| First Submitted: | 06/15/2020 |
| Estimated Enrollment Submitted: | 06/18/2020 |
| First Posted: | 06/21/2020 |
| Last Update Submitted: | 06/18/2020 |
| Last Update Posted: | 06/21/2020 |
| Actual Study Start Date: | 07/28/2019 |
| Estimated Primary Completion Date: | 06/29/2021 |
| Estimated Study Completion Date: | 06/29/2021 |
Condition or disease
Intervention/treatment
Device: Study group
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Study group 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: Study group 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. |
| No Intervention: Control group Participants in the control group receive conventional rehabilitation therapy over 50 minutes on weekdays. |
Eligibility Criteria
| Ages Eligible for Study | 20 Years To 20 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Stroke Impact Scale (SIS) 3.0 Questionnaire [Baseline (Pre-intervention at 2 days after enrollment)]
2. Post-Intervention Change of Stroke Impact Scale (SIS) 3.0 Questionnaire [Change from baseline SIS scores at 18 days after enrollment]
3. 3-Month Follow-Up Change of Stroke Impact Scale (SIS) 3.0 Questionnaire [Change from baseline SIS scores at 92 days after enrollment]
4. Post-Intervention of Adverse Events or SAE [16 days]
Secondary Outcome Measures
1. Motricity Index (MI) Upper Extremity Test [Baseline (Pre-intervention) at 2 days after enrollment]
2. Post-Intervention Change of Motricity Index (MI) Upper Extremity Test [Change from baseline MI scores at 18 days after enrollment]
3. 3-Month Follow-Up Change of Motricity Index (MI) Upper Extremity Test [Change from baseline MI scores at 92 days after enrollment]
4. Fugl-Meyer Assessment for Upper Extremity (FMA-UE) [Baseline (Pre-intervention) at 2 days after enrollment]
5. Post-Intervention Change of Fugl-Meyer Assessment for Upper Extremity (FMA-UE) [Change from baseline FMA-UE scores at 18 days after enrollment]
6. 3-Month Follow-Up Change of Fugl-Meyer Assessment for Upper Extremity (FMA-UE) [Change from baseline FMA-UE scores at 92 days after enrollment]
7. Self-Care in Functional Independence Measure (FIM) Instrument [Baseline (Pre-intervention) at 2 days after enrollment]
8. Post-Intervention Change of Self-Care in Functional Independence Measure (FIM) Instrument [Change from baseline self-care scores at 18 days after enrollment]
9. 3-Month Follow-Up Change of Self-Care in Functional Independence Measure (FIM) Instrument [Change from baseline self-care scores at 92 days after enrollment]
10. Arm Movement Ratio (AMR) Test [Baseline (Pre-intervention) at 1 day after enrollment]
11. Post-Intervention Change of Arm Movement Ratio (AMR) Test [Change from baseline AMR scores at 19 days after enrollment]
12. 3-Month Follow-Up Change of Arm Movement Ratio (AMR) Test [Change from baseline AMR scores at 93 days after enrollment]
