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

June 19, 2020 updated by: Chien-Min Chen, Chang Gung Memorial Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Pozi, Taiwan, 613
        • Chiayi Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
No Intervention: Control group
Participants in the control group receive conventional rehabilitation therapy over 50 minutes on weekdays.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke Impact Scale (SIS) 3.0 Questionnaire
Time Frame: Baseline (Pre-intervention at 2 days after enrollment)
Health-Related Quality of Life
Baseline (Pre-intervention at 2 days after enrollment)
Post-Intervention Change of Stroke Impact Scale (SIS) 3.0 Questionnaire
Time Frame: Change from baseline SIS scores at 18 days after enrollment
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
Time Frame: Change from baseline SIS scores at 92 days after enrollment
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
Time Frame: 16 days
Proportion of intervention-related adverse events or SAE
16 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motricity Index (MI) Upper Extremity Test
Time Frame: Baseline (Pre-intervention) at 2 days after enrollment
Motor impairment and function
Baseline (Pre-intervention) at 2 days after enrollment
Post-Intervention Change of Motricity Index (MI) Upper Extremity Test
Time Frame: Change from baseline MI scores at 18 days after enrollment
Post-intervention motor impairment and function
Change from baseline MI scores at 18 days after enrollment
3-Month Follow-Up Change of Motricity Index (MI) Upper Extremity Test
Time Frame: Change from baseline MI scores at 92 days after enrollment
3-month follow-up motor impairment and function
Change from baseline MI scores at 92 days after enrollment
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Time Frame: Baseline (Pre-intervention) at 2 days after enrollment
Motor impairment and function
Baseline (Pre-intervention) at 2 days after enrollment
Post-Intervention Change of Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Time Frame: Change from baseline FMA-UE scores at 18 days after enrollment
Post-intervention motor impairment and function
Change from baseline FMA-UE scores at 18 days after enrollment
3-Month Follow-Up Change of Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Time Frame: Change from baseline FMA-UE scores at 92 days after enrollment
3-month follow-up motor impairment and function
Change from baseline FMA-UE scores at 92 days after enrollment
Self-Care in Functional Independence Measure (FIM) Instrument
Time Frame: Baseline (Pre-intervention) at 2 days after enrollment
The FIM is an 18-item instrument measuring a person's level of disability in terms of burden of care in six areas including self-care, continence, mobility, transfers, communication, and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1 = total assistance required, 7 = complete independence). Six items (eating, grooming, bathing, dressing upper body, dressing lower body, and toileting) of self care will be scored and summed in this study.
Baseline (Pre-intervention) at 2 days after enrollment
Post-Intervention Change of Self-Care in Functional Independence Measure (FIM) Instrument
Time Frame: Change from baseline self-care scores at 18 days after enrollment
The FIM is an 18-item instrument measuring a person's level of disability in terms of burden of care in six areas including self-care, continence, mobility, transfers, communication, and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1 = total assistance required, 7 = complete independence). Six items (eating, grooming, bathing, dressing upper body, dressing lower body, and toileting) of self care will be scored and summed in this study.
Change from baseline self-care scores at 18 days after enrollment
3-Month Follow-Up Change of Self-Care in Functional Independence Measure (FIM) Instrument
Time Frame: Change from baseline self-care scores at 92 days after enrollment
The FIM is an 18-item instrument measuring a person's level of disability in terms of burden of care in six areas including self-care, continence, mobility, transfers, communication, and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1 = total assistance required, 7 = complete independence). Six items (eating, grooming, bathing, dressing upper body, dressing lower body, and toileting) of self care will be scored and summed in this study.
Change from baseline self-care scores at 92 days after enrollment
Arm Movement Ratio (AMR) Test
Time Frame: Baseline (Pre-intervention) at 1 day after enrollment
The AMR, the ratio of arm use duration between the more and less affected arm, is detected and calculated by an accelerometer. The participants are asked to wear one accelerometer (ActiGraph wGT3x-BT, ActiGraph, LLC., Pensacola, FL, USA) on each arm for 7 hours.
Baseline (Pre-intervention) at 1 day after enrollment
Post-Intervention Change of Arm Movement Ratio (AMR) Test
Time Frame: Change from baseline AMR scores at 19 days after enrollment
The AMR, the ratio of arm use duration between the more and less affected arm, is detected and calculated by an accelerometer. The participants are asked to wear one accelerometer (ActiGraph wGT3x-BT, ActiGraph, LLC., Pensacola, FL, USA) on each arm for 7 hours.
Change from baseline AMR scores at 19 days after enrollment
3-Month Follow-Up Change of Arm Movement Ratio (AMR) Test
Time Frame: Change from baseline AMR scores at 93 days after enrollment
The AMR, the ratio of arm use duration between the more and less affected arm, is detected and calculated by an accelerometer. The participants are asked to wear one accelerometer (ActiGraph wGT3x-BT, ActiGraph, LLC., Pensacola, FL, USA) on each arm for 7 hours.
Change from baseline AMR scores at 93 days after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Chien-Min Chen, MD, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2019

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

June 16, 2020

First Submitted That Met QC Criteria

June 19, 2020

First Posted (Actual)

June 22, 2020

Study Record Updates

Last Update Posted (Actual)

June 22, 2020

Last Update Submitted That Met QC Criteria

June 19, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201801607A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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