Effects of Wearable Sensor Based Virtual Reality Game on Balance 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
- 40
- 试验地点
- 1
- 主要终点
- Berg Balance Scale
研究概览
简要总结
Pablo is a new virtual reality (VR) game combined with wearable motion sensor system which can targeted intervention in an interactive environment, immediate and sensitive feedback about the user's performance, a motivating effect due to game-based feature. Unlike commercial camera systems such as Kinect or force platforms, the systems require a continuous sightline or restrict the base of support which may increase risk of falling. Few of studies had investigated the rehabilitation effects on balance with Pablo for patients with stroke. The purpose of this study is to investigate the effects of virtual reality training through Pablo system in patients with chronic stroke.
详细描述
Pablo is a new virtual reality (VR) game combined with wearable motion sensor system which can targeted intervention in an interactive environment, immediate and sensitive feedback about the user's performance, a motivating effect due to game-based feature. Unlike commercial camera systems such as Kinect or force platforms, the systems require a continuous sightline or restrict the base of support which may increase risk of falling. Few of studies had investigated the rehabilitation effects on balance with Pablo for patients with stroke.
PURPOSE: The purpose of this study is to investigate the effects of virtual reality training through Pablo system in patients with chronic stroke.
METHODS: A prospective, randomized, controlled, blinded assessor design was used. Patients with stroke were recruited and randomly assigned to a "virtual reality(VR) group" (n = 20) and "functional balance training (FBT) group" (n = 20). After 18 training sessions (60 minutes per session, 2 sessions per week), outcome measures which included the Berg Balance Scale, the Timed Up and Go Test (cognition), a gait analysis, the Activities-Specific Balance Confidence scale, Stroke Impact Scale (SIS), Level of pleasure, and frequency of adverse events. The data were analyzed using nonparametric tests, and significance was indicated at α < 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
- •Patients were included if they had first stroke with hemiplegia.
- •Could stand for 5 minutes without support.
- •Chronicity of >6 months.
- •Could understand instructions.
- •Brunnstrom stage of LE ≥Ⅲ.
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.
结局指标
主要结局
Berg Balance Scale
时间窗: Change from Baseline to 9 weeks follow up
It is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
次要结局
- Modified Physical Activity Enjoyment Scale(Every training session during 18 sessions, total sessions continued to 9 weeks)
- Functional reach test(Change from Baseline to 9 weeks follow up)
- Time up and go-cognition(Change from Baseline to 9 weeks follow up)
- Activities-specific Balance Confidence scale(Change from Baseline to 9 weeks follow up)
- Adverse event times(Every training session during 18 sessions, total sessions continued to 9 weeks)
- Stroke Impact Scale-physical domain(Change from Baseline to 9 weeks follow up)