Effects of Wearable Sensor Based Virtual Reality Game on Upper Extremity Function for Patients With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment-upper extremity
研究概览
简要总结
Virtual reality training had already been used in stroke rehabilitation, and previous studies supported that it could improve upper extremity ability and increase motivation and pleasure than conventional methods. Pablo is a new VR game combined with motion sensor system which can detect subject's activities. Unlike commercial camera systems such as Kinect or XBOX, the systems require a continuous sightline or enough active range of motion which may increase risk of compensatory movement. Few of studies had investigated the rehabilitation effects on upper extremity with Pablo for patients with stroke.The purpose of this study is to investigate the effects of virtual reality upper extremity training through Pablo system in patients with chronic stroke.
详细描述
PURPOSE: The purpose of this study is to investigate the effects of virtual reality upper extremity training through Pablo system in patients with chronic stroke.
METHODS:Patients with mild to moderate motor deficits were recruited and randomly assigned to "VR plus standard rehabilitation group"(n=19), and "standard rehabilitation group" (n=19). After 12 training sessions (60 minutes a time, 2 times a week), the performance was assessed by a blinded assessor. The outcome measures included Fugl-Meyer Assessment-Upper Limb section(FMAUE), Box and block test(BBT), Dynanometer, active range of motion of shoulder and elbow,and Stroke Impact Scale.Modified Physical Activity Enjoyment Scale and adverse effect were recorded after each sessions.Collected data will be analyzed with sample T test by SPSS version 20.0, and alpha level was set at 0.05.
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)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First stroke with hemiplegia,
- •Chronicity of >6 months
- •Could understand instructions
- •Brunnstrom stage of UE ≥IV.
排除标准
- •Patients who were aged <20 years and >75 years
- •Patients with visual or auditory impairment who were unable to see or hear the feedback from the device clearly
- •Montreal Cognitive Assessment <16
- •Modified Ashworth Scale score of >2
- •Patients with other medical symptoms that can affect movement were excluded.
结局指标
主要结局
Fugl-Meyer Assessment-upper extremity
时间窗: Change from Baseline at 9 weeks
The Fugl-Meyer Assessment-upper extremity (FMA-UE) measures motor impairment in the upper extremity. The assessment consists of 33 items, including movement, reflex, grasp, and coordination, and a total score of 66.
次要结局
- Box and block test(Change from Baseline at 9 weeks)
- Dynanometer(Change from Baseline at 9 weeks)
- Stroke Impact Scale(Change from Baseline at 9 weeks)
- Active range of motion of shoulder and elbow(Change from Baseline at 9 weeks)
- Modified Physical Activity Enjoyment Scale(Every training session during 18 sessions, total sessions continued to 9 weeks)
- Adverse effect times(Every training session during 18 sessions, total sessions continued to 9 weeks)