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

NCT04441177 | Unknown

• 1 other identifier: 201801607A3
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Stroke; Virtual Reality; Rehabilitation

Outcome Measures

Primary Outcomes (4)

• Stroke Impact Scale (SIS) 3.0 Questionnaire

  Health-Related Quality of Life

  Baseline (Pre-intervention at 2 days after enrollment)

• Post-Intervention Change of Stroke Impact Scale (SIS) 3.0 Questionnaire

  Post-intervention Health-Related Quality of Life

  Change from baseline SIS scores at 18 days after enrollment

• 3-Month Follow-Up Change of Stroke Impact Scale (SIS) 3.0 Questionnaire

  3-month follow-up Health-Related Quality of Life

  Change from baseline SIS scores at 92 days after enrollment

• Post-Intervention of Adverse Events or SAE

  Proportion of intervention-related adverse events or SAE

  16 days

Secondary Outcomes (12)

• Motricity Index (MI) Upper Extremity Test

  Baseline (Pre-intervention) at 2 days after enrollment

• Post-Intervention Change of Motricity Index (MI) Upper Extremity Test

  Change from baseline MI scores at 18 days after enrollment

• 3-Month Follow-Up Change of Motricity Index (MI) Upper Extremity Test

  Change from baseline MI scores at 92 days after enrollment

• Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

  Baseline (Pre-intervention) at 2 days after enrollment

• Post-Intervention Change of Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

  Change from baseline FMA-UE scores at 18 days after enrollment

Study Arms (2)

Study group

EXPERIMENTAL

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: PlayStation®VR training

Control group

NO INTERVENTION

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

Interventions

PlayStation®VR training 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.

Study group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chiayi Chang Gung Memorial Hospital

Pozi, 613, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chien-Min Chen, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Pre-intervention, post-intervention, and 3-month follow-up HRQOL will be assessed by the Stroke Impact Scale (SIS) 3.0. Motricity Index (MI) and Fugl-Meyer Assessment (FMA), Functional Independence Measure (FIM), and arm movement ratio (AMR) will also be checked before intervention, after intervention, and at 3-month follow-up. One blinded occupational therapist will evaluate the outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All participants are randomly allocated to study group and control group. Each participant's main study period is set as 16 days with additional follow-up time at post-intervention 3 months. 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.

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 22, 2020
• Study Start: July 29, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)