Effects of PlayStation®VR on the Health-Related Quality of Life in Stroke Patients Undergoing Inpatient Rehabilitation: a Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- 3-Month Follow-Up Change of Stroke Impact Scale (SIS) 3.0 Questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
3-Month Follow-Up Change of Stroke Impact Scale (SIS) 3.0 Questionnaire
时间窗: Change from baseline SIS scores at 92 days after enrollment
3-month follow-up Health-Related Quality of Life
Post-Intervention of Adverse Events or SAE
时间窗: 16 days
Proportion of intervention-related adverse events or SAE
Stroke Impact Scale (SIS) 3.0 Questionnaire
时间窗: Baseline (Pre-intervention at 2 days after enrollment)
Health-Related Quality of Life
Post-Intervention Change of Stroke Impact Scale (SIS) 3.0 Questionnaire
时间窗: Change from baseline SIS scores at 18 days after enrollment
Post-intervention Health-Related Quality of Life
次要结局
- 3-Month Follow-Up Change of Motricity Index (MI) Upper Extremity Test(Change from baseline MI scores at 92 days after enrollment)
- 3-Month Follow-Up Change of Arm Movement Ratio (AMR) Test(Change from baseline AMR scores at 93 days after enrollment)
- 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 Fugl-Meyer Assessment for Upper Extremity (FMA-UE)(Change from baseline FMA-UE scores at 92 days after enrollment)
- Post-Intervention Change of Self-Care in Functional Independence Measure (FIM) Instrument(Change from baseline self-care scores at 18 days after enrollment)
- Arm Movement Ratio (AMR) Test(Baseline (Pre-intervention) at 1 day 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)
- 3-Month Follow-Up Change of Self-Care in Functional Independence Measure (FIM) Instrument(Change from baseline self-care scores at 92 days after enrollment)
- Post-Intervention Change of Arm Movement Ratio (AMR) Test(Change from baseline AMR scores at 19 days after enrollment)
- Self-Care in Functional Independence Measure (FIM) Instrument(Baseline (Pre-intervention) at 2 days after enrollment)
研究者
Chien-Min Chen
Principal Investigator
Chang Gung Memorial Hospital