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

NCT ID: NCT04441177

Last Updated: 2020-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-29
• Study Completion Date: 2021-06-30

Brief Summary

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

PlayStation®VR training

Intervention Type: DEVICE

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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PlayStation®VR training

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chien-Min Chen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chien-Min Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Chiayi Chang Gung Memorial Hospital

Pozi, , Taiwan

Countries

Taiwan

Other Identifiers

201801607A3

Identifier Type: -

Identifier Source: org_study_id