Proximal- Versus Distal-Prioritized Robotic Practice Plus Kinetic Exergaming in Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- Change from Baseline 10 meter walk test (10-MWT) at 6 weeks and 18 weeks
研究概览
简要总结
This research program aims at investigating the effects of upper-limb robotic therapy primed with interactive exergaming as an innovative hybrid regimen in stroke rehabilitation.
详细描述
Robotic therapy can potentially be a movement-based priming technique to promote rebalancing of cortical excitability and create an enriched neuroplastic environment by priming the brain to facilitate motor and functional recovery. The proximal priority and distal priority robotic priming techniques may bring differential effects. This proposed research project aims to: (1) examine the effects of proximal priority versus distal priority of bilateral robotic priming combined with exergaming on sensorimotor function, daily function, self-efficacy, quality of life, and motor control strategy in patients with stroke, (2) investigate the 3-month retention effects of the three approaches, and (3) identify the potential predictors of functionally relevant changes after therapy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a first ever-stroke≧3 months
- •age range between 20 to 80 years
- •baseline Fugl-Meyer assessment of upper extremity scale (FMA-UE) between 18 to 56
- •no excessive muscle spasticity of the affected extremities (Modified Ashworth Scale < 3 at any joints)
- •able to follow examiners' commands and study instructions (Mini-Mental State Examination score≧22)
- •can maintain a step-standing position for at least 30 seconds
- •can walk for at least 10 meters with or without device
- •no participation in further experimental rehabilitation or drug studies during the duration of the project
排除标准
- •acute inflammation and pain
- •concomitant neurologic, neuromuscular or orthopedic conditions that may impede participation in this research.
结局指标
主要结局
Change from Baseline 10 meter walk test (10-MWT) at 6 weeks and 18 weeks
时间窗: Baseline, 6 weeks, and 18 weeks
1.10 meter walk test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function. 2.The total time is recorded in m/s 3.The lower total time means the greater recovery of walking speed.
Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks and 18 weeks
时间窗: Baseline, 6 weeks, and 18 weeks
1. The upper-extremity subscale of the FMA will be used to assess motor impairment. 2. There are 33 UE items that assess movements and reflexes of the shoulder/elbow/forearm, wrist, and hand, and coordination/speed. Each item is on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). 3. The maximum score is 66, with a subscale score of 42 for the proximal part of the arms (shoulder/elbow) and 24 for the distal part of the arm (wrist/hand/coordination) 4. The higher summed score means the greater recovery of motor impairment.
次要结局
- Functional Independence Measure (FIM)(Baseline, 6 weeks, and 18 weeks)
- Medical Research Council scale (MRC)(Baseline, 6 weeks, and 18 weeks)
- The ActiGraph GX3 accelerometers (ActiGraph, Shalimar, FL,USA)(Baseline, 6 weeks, and 18 weeks)
- Stroke Self-Efficacy Questionnaire (SSEQ)(Baseline, 6 weeks, and 18 weeks)
- Adverse events (pain and fatigue)(through study completion, an average of 18 weeks)