Clinical trial NCT04441177: Effects of PlayStation®VR on the HRQOL in Stroke Patients Undergoing Inpatient Rehabilitation
Official title: Effects of PlayStation®VR on the Health-Related Quality of Life in Stroke Patients Undergoing Inpatient Rehabilitation: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Stroke
Virtual Reality
Rehabilitation
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Stroke Impact Scale (SIS) 3.0 Questionnaire
timeFrame: Baseline (Pre-intervention at 2 days after enrollment)
measure: Post-Intervention Change of Stroke Impact Scale (SIS) 3.0 Questionnaire
timeFrame: Change from baseline SIS scores at 18 days after enrollment
measure: 3-Month Follow-Up Change of Stroke Impact Scale (SIS) 3.0 Questionnaire
timeFrame: Change from baseline SIS scores at 92 days after enrollment
measure: Post-Intervention of Adverse Events or SAE
timeFrame: 16 days
Secondary outcomes:
measure: Motricity Index (MI) Upper Extremity Test
timeFrame: Baseline (Pre-intervention) at 2 days after enrollment
measure: Post-Intervention Change of Motricity Index (MI) Upper Extremity Test
timeFrame: Change from baseline MI scores at 18 days after enrollment
measure: 3-Month Follow-Up Change of Motricity Index (MI) Upper Extremity Test
timeFrame: Change from baseline MI scores at 92 days after enrollment
measure: Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
timeFrame: Baseline (Pre-intervention) at 2 days after enrollment
measure: Post-Intervention Change of Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
timeFrame: Change from baseline FMA-UE scores at 18 days after enrollment
measure: 3-Month Follow-Up Change of Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
timeFrame: Change from baseline FMA-UE scores at 92 days after enrollment
measure: Self-Care in Functional Independence Measure (FIM) Instrument
timeFrame: Baseline (Pre-intervention) at 2 days after enrollment
measure: Post-Intervention Change of Self-Care in Functional Independence Measure (FIM) Instrument
timeFrame: Change from baseline self-care scores at 18 days after enrollment
measure: 3-Month Follow-Up Change of Self-Care in Functional Independence Measure (FIM) Instrument
timeFrame: Change from baseline self-care scores at 92 days after enrollment
measure: Arm Movement Ratio (AMR) Test
timeFrame: Baseline (Pre-intervention) at 1 day after enrollment
measure: Post-Intervention Change of Arm Movement Ratio (AMR) Test
timeFrame: Change from baseline AMR scores at 19 days after enrollment
measure: 3-Month Follow-Up Change of Arm Movement Ratio (AMR) Test
timeFrame: Change from baseline AMR scores at 93 days after enrollment
Other outcomes:
Locations:
city: Pozi
country: Taiwan
facility: Chiayi Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chien-Min Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: