NCT04441177

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

Status unknown NA Last updated 22 June 2020

What this trial tests

NA trial testing PlayStation®VR training in Stroke in 80 participants. Status unknown.

Timeline

29 July 2019

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	Chang Gung Memorial Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	80
Start date	29 July 2019
Primary completion	30 June 2021
Estimated completion	30 June 2021
Sites	1 location across Taiwan

Drugs / interventions tested

• PlayStation®VR training

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

Chang Gung Memorial Hospital

Who can join

Adults 20 to 80, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Reversing the Ruin: Rehabilitation, Recovery, and Restoration After Stroke.
   Stockbridge MD, Bunker LD, Hillis AE. · · 2022 · cited 6× · PMID 36181577 · DOI 10.1007/s11910-022-01231-5