Stroke Clinical Trial
Official title:
Effects of PlayStation®VR on the Health-Related Quality of Life in Stroke Patients Undergoing Inpatient Rehabilitation: a Pilot Study
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.
n/a
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