The Effects on Hand Function With Robot-assisted Rehabilitation 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
- 25
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment：Upper Limb section
研究概览
简要总结
Robotic therapy can deliver larger amounts of upper extremity movement practice for stroke rehabilitation. Although the treatment effects were supported in studies, there are still limitations in clinical intervention. The study will use the robot-assisted hand rehabilitation with a Gloreha device. Thirty patients with moderate motor deficits were recruited and randomized into 2 treatment groups, AB or BA (A = 12 times of robot-assisted hand rehabilitation, B = 12 times of standard therapy) for 12 weeks of treatment (Sixty minutes a time, twice a week), 1 month of break between conditions for washout period. The performance was assessed by a blinded assessor for five times (pre-test1, post-test 1, pre-test2, post-test 2, follow up at three month). The outcome measures Fugl-Meyer Assessment-Upper Limb section(FMA-UE),Box and block test(BBT), Maximal voluntary contraction(MVC) of extensor digitorum communis(EDC), Abductor pollicis brevis(APB), Flexor digitorum(FD), Dynanometer, Semmes-Weinstein hand monofilament (SWM), Revision of the Nottingham Sensory Assessment (EmNSA), Modified Barthel Index. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at 0.05. The hypothesis are robot-assisted hand rehabilitation with a Gloreha device has positive effects on sensory, motor, hand function, and ADL ability among patients with stroke.
详细描述
Many stroke survivors suffered problems with the upper extremity, such as paresis, synergy movement, hypertonicity, jag movement, sensory deficit. An inability to use the upper extremity in daily life can lead to loss of independence with ADLs and of important occupations (eg,work, driving). For individuals with more severe paresis, the potential for recovery of upper extremity function is greatly reduced. Robotic therapy can deliver larger amounts of upper extremity movement practice for these individuals. Although the Robotic therapy appears to provide some benefit for upper extremity motor abilities and participation but is of uncertain utility compared with dose-matched conventional upper limb exercise therapies. Objective: To investigate the effects of robot-assisted hand rehabilitation with a Gloreha device on sensory, motor, and ADL ability for patients with stroke.
Materials and Methods
Thirty patients with moderate motor deficits were recruited and randomized into 2 treatment groups, AB or BA (A = 12 times of robot-assisted hand rehabilitation, B = 12 times of standard therapy) for 12 weeks of treatment (Sixty minutes a time, twice a week), 1 month of break between conditions for washout period. The performance was assessed by a blinded assessor for five times (pre-test1, post-test 1, pre-test2, post-test 2, follow up at three month). The outcome measures Fugl-Meyer Assessment-Upper Limb section(FMA-UE),Box and block test(BBT), Maximal voluntary contraction(MVC) of extensor digitorum communis(EDC), Abductor pollicis brevis(APB), Flexor digitorum(FD), Dynanometer, Semmes-Weinstein hand monofilament (SWM), Revision of the Nottingham Sensory Assessment (EmNSA) for hand evaluations, Modified Barthel Index for ADL ability. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at 0.05. The hypothesis are robot-assisted hand rehabilitation with a Gloreha device has positive effects on sensory, motor, hand function, and ADL ability among patients with stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single Blind (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 > 3 months
- •Could understand the instructions
- •Brunnstrom stageⅡ-Ⅴ
- •Sensory impairment (Revision of the Nottingham Sensory Assessment-Tatile< 2; Kinaesthetic < 3)
- •Modified Ashworth Scale < 3
排除标准
- •Age younger than 20 and older than75 years
- •Individuals with visual or auditory impairment who couldn't see or hear the feedback from the device clearly
- •Individuals with other medical symptoms that can affect movement
研究组 & 干预措施
Group A
In the phase 1 :12 training sessions of Robot-assisted hand rehabilitation(60 minutes a time, 2 times a week); In the phase 2 :12 training sessions of Standard treatment only. (60 minutes a time, 2 times a week)
干预措施: Robot-assisted hand rehabilitation (Behavioral)
Group A
In the phase 1 :12 training sessions of Robot-assisted hand rehabilitation(60 minutes a time, 2 times a week); In the phase 2 :12 training sessions of Standard treatment only. (60 minutes a time, 2 times a week)
干预措施: Standard treatment (Behavioral)
Group B
In the phase 1 :12 training sessions of Standard treatment only(60 minutes a time, 2 times a week) ; In the phase 2 :12 training sessions of Robot-assisted hand rehabilitation(60 minutes a time, 2 times a week)
干预措施: Robot-assisted hand rehabilitation (Behavioral)
Group B
In the phase 1 :12 training sessions of Standard treatment only(60 minutes a time, 2 times a week) ; In the phase 2 :12 training sessions of Robot-assisted hand rehabilitation(60 minutes a time, 2 times a week)
干预措施: Standard treatment (Behavioral)
结局指标
主要结局
Fugl-Meyer Assessment：Upper Limb section
时间窗: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Upper Limb motor function
次要结局
- Revision of the Nottingham Sensory Assessment(Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month)
- Dynanometer(Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month)
- Box and block test(Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month)
- EMG: record maximal voluntary contraction(MVC) of brachioradialis, extensor carpi, abductor pollicis longus(Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month)
- Semmes-Weinstein hand monofilament(Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month)
- Modified barthel index(Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month)