Effects of Robotic-aided Therapy Combined With Bilateral Arm Training on Motor Performance and Electrophysiological Parameters of Upper Extremity for the Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Change in the result of Motor Activity Log
研究概览
简要总结
Task-specific repetitive training, an usual care in occupational therapy practice, and robotic-aided rehabilitation with bilateral practice to improve limb's movement control has been popularised; however the difference in treatment effects between this two therapeutic strategies has been rarely described. The aim of the study was to compare the efficacy of robotic-assisted therapy with bilateral practice (RTBP) and usual care on task and motor performance for chronic stroke patients.
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
- •chronic stroke patients with unilateral cerebral infarction or hemorrhage and whose disease duration was more than six months following stroke
- •no evidence of any other cerebral pathology in study screening CT scan
- •a score for the Fugl-Meyer upper extremity motor assessment ranging from 23-53 corresponding to poor to notable arm-hand capacity
- •pre stroke ability to speak the Chinese
- •without any other possible somatic sensory impairment, no major cognitive-perceptual deficit based on the results of selective neuropsychological tests, such as the mini-mental state examination (MMSE) and Lowenstein occupational therapy cognitive assessment (LOTCA)
- •premorbid right-handedness
排除标准
- •less than six months following stroke
- •CT shows multiple cerebral infarction or hemorrhage
- •whose comprehension skills were insufficient to understand instructions
- •individuals whose score of MMSE was lower than 24 or sub-item scores of visual perception, spatial perception, praxis, and visuomotor organization in LOTCA was lower than 8, 6, 6, and 14, respectively
- •premorbid left-handedness
研究组 & 干预措施
Robotic-aided rehabilitation with bilateral practice
In addition to a 10-minutes sensorimotor stimulation programs, the experimental group received 40-minutes Robotic-assisted Therapy with Bilateral Practice programs.
干预措施: Robotic-assisted Therapy with Bilateral Practice (Other)
Robotic-aided rehabilitation with bilateral practice
In addition to a 10-minutes sensorimotor stimulation programs, the experimental group received 40-minutes Robotic-assisted Therapy with Bilateral Practice programs.
干预措施: Sensorimotor Stimulation Program (Other)
Unilateral task-specific training
In addition to a 10-minutes sensorimotor stimulation programs, the control subjects received 40-minute unilateral task-specific training.
干预措施: Unilateral Task-specific Training (Other)
Unilateral task-specific training
In addition to a 10-minutes sensorimotor stimulation programs, the control subjects received 40-minute unilateral task-specific training.
干预措施: Sensorimotor Stimulation Program (Other)
结局指标
主要结局
Change in the result of Motor Activity Log
时间窗: Baseline, endpoint (4 weeks) and follow-up (16 weeks) assessments
Motor activity log is a structured interview with testing sensitivity used to examine how much (amount of use, AOU) and how well (quality of movement, QOM) the subject uses their more-affected arm. For the 30 items MAL, each item is scored on a 0-5-ordinal scale.
次要结局
- Change in the result of Fugl-Meyer assessment for UE motor function(Baseline, endpoint (4 weeks) and follow-up (16 weeks) assessments)
- Change in root mean square (RMS) value and the median frequency of the power spectrum of each detected motor unit action potential during maximum voluntary contraction(Baseline, endpoint (4 weeks) and follow-up (16 weeks) assessments)