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

Chang Gung Medical Foundation

Status: Unknown

Conditions: Stroke

Treatments: Device: PlayStation®VR training

Study type: Interventional

Funder types: Other

Identifiers

NCT04441177

201801607A3

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Study group

Experimental group

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.

Treatment:

Device: PlayStation®VR training

Control group

No Intervention group

Description:

Participants in the control group receive conventional rehabilitation therapy over 50 minutes on weekdays.