The Effects of the EMG-driven Exoskeleton Hand Robotic Training Device on Upper Extremity Motor and Physiological Function, Daily Functions, Quality of Life and Self-efficacy in Brain Injury Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change scores of Fugl-Myer Assessment (FMA)
研究概览
简要总结
The purpose of this study is to examine the effects of the EMG-driven exoskeleton hand robotic training device on upper extremity motor and physiological function, daily functions, quality of life and self-efficacy in brain injury patients.
详细描述
The purpose of this study was to 1) examine the effects of EMG-driven robot-assisted intervention, and 2) examine whether the robot-assisted therapy is as effective as conventional intervention. The study was conducted using a randomized, two-period crossover design. Participants were randomly assigned to group 1 or group 2 using a computer-generated list. Participants in group 1 received 12 sessions of robot-assisted intervention first, followed by a one-month washout period, and then received 12 sessions of conventional intervention. Participants in group 2 received 12 sessions of conventional intervention first, followed by a one-month washout period, and then received 12 sessions of robot-assisted intervention. Outcome measures were performed before the intervention, after the first 12-session intervention, and after the second 12-session intervention.
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)
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
- •unilateral stroke ≥ 3 months prior to study enrollment
- •Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score <60
- •without excessive spasticity in any of the UE joint (modified Ashworth scale ≤3)
- •Mini Mental State Exam (MMSE) score > 24, indicating no serious cognitive impairment
- •between the ages of 20 and 75 years.
排除标准
- •histories of other neurological diseases such as dementia and peripheral polyneuropathy
- •difficulties in following and understanding instructions such as global aphasia
- •enroll in other rehabilitation or drug studies simultaneously
- •receiving Botulinum toxin injections within 3 months.
结局指标
主要结局
Change scores of Fugl-Myer Assessment (FMA)
时间窗: Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
The UE-FMA subscale will be used to assess the sensorimotor impairment level of UE in patients after stroke. The UE-FMA contains 33 movements with a score range from 0 to 66. A higher UE-FMA score indicates less impairment of the paretic limb. The validity and reliability of FMA is good to excellent.
Change scores of Wolf Motor Function Test (WMFT)
时间窗: Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
The WMFT is a reliable method to evaluate the UE motor ability in patients after stroke. The WMFT contains 15 function-based tasks and 2 strength-based tasks. The time (WMFT-time) and the functional ability (WMFT-quality) for an individual to complete the tasks will be recorded. A shorter WMFT-time and a larger WMFT-quality score indicate a faster movement and better quality of movement, respectively.
Change scores of Motor Activity Log (MAL)
时间窗: Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
The MAL will be used to assess the amount of use (AOU) and quality of movement (QOM) of the paretic UE. The MAL is a semi-structured interview that tests object manipulation and gross motor activities of daily living. The psychometric properties of MAL have been well-established, and a higher MAL score indicates better movement quality.
Change scores of Action Research Arm Test (ARAT)
时间窗: Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
The Action Research Arm Test (ARAT) evaluates 19 tests of arm motor function, both distally and proximally. Each test is given an ordinal score of 0, 1, 2, or 3, with higher values indicating better arm motor status. The total ARAT score is the sum of the 19 tests, and thus the maximum score is 57.
次要结局
- Change scores of Modified Ashworth Scale (MAS)(Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline)
- Change scores of Active Range of Motion (AROM)(Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline)
- Change scores of stroke self-efficacy questionnaire (SSEQ)(Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline)
- Change scores of Mini-Mental State Exam (MMSE)(Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline)
- Change scores of Jamar hand dynamometer(Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline)