Unilateral and Bilateral Approaches to Robotic Therapy Hybridized With Mirror Therapy in Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Assessment-Upper Extremity subscale (FMA-UE)
研究概览
简要总结
The goal of this clinical trial is to compare the effects of three groups: (1) unilateral robotic therapy with computerized visual feedback plus unilateral innovative mirror therapy, (2) bilateral robotic therapy with computerized visual feedback plus bilateral innovative mirror therapy, and (3) dose-matched conventional rehabilitation as the control. The investigators will also study the factors predictive of treatment success, identify key predictors of clinical improvement, and distinguish patient profiles most likely to benefit from each regimen. The findings of this clinical trial are expected to advance knowledge about the synergistic effects of unilateral and bilateral hybrid programs. The predictive study of treatment outcomes will inform patient selection in precision rehabilitation toward personalized stroke management.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) a first ever-stroke≧3 months and less than 2 years, (2) age range between 30 to 80 years, (3) baseline Fugl-Meyer Assessment-Upper Extremity subscale (FMA-UE) between 18 to 56, (4) no excessive muscle spasticity of the affected extremities (Modified Ashworth Scale < 3 at any joints), (5) able to follow examiners' commands and study instructions (Montreal Cognitive Assessment score≧22), and (6) no fracture of upper extremities within the past 3 months, and (7) no participation in any other experimental rehabilitation or drug studies during study period of this project.
排除标准
- •(1) acute inflammation and pain, (2) receiving botulinum toxin injections within the past 3 months, and (3) concomitant neurologic, neuromuscular or orthopedic conditions that may interfere with participation in this research.
研究组 & 干预措施
Unilateral RT plus unilateral innovative MT
Unilateral robotic therapy (RT) with computerized visual feedback plus unilateral innovative mirror therapy (MT)
干预措施: Robotic therapy (RT) (Other)
Unilateral RT plus unilateral innovative MT
Unilateral robotic therapy (RT) with computerized visual feedback plus unilateral innovative mirror therapy (MT)
干预措施: Mirror therapy (MT) (Other)
Bilateral RT plus bilateral innovative MT
Bilateral robotic therapy (RT) with computerized visual feedback plus bilateral innovative mirror therapy (MT)
干预措施: Robotic therapy (RT) (Other)
Bilateral RT plus bilateral innovative MT
Bilateral robotic therapy (RT) with computerized visual feedback plus bilateral innovative mirror therapy (MT)
干预措施: Mirror therapy (MT) (Other)
Dose-matched conventional rehabilitation
Dose-matched conventional rehabilitation as the control
干预措施: Dose-matched control intervention (Other)
结局指标
主要结局
Fugl-Meyer Assessment-Upper Extremity subscale (FMA-UE)
时间窗: Baseline, 6 weeks, and 18 weeks
次要结局
- Functional Ambulation Category (FAC)(Baseline, 6 weeks, and 18 weeks)
- Grip and pinch strength(Baseline, 6 weeks, and 18 weeks)
- Motor Activity Log (MAL)(Baseline, 6 weeks, and 18 weeks)
- Box and Block Test (BBT)(Baseline, 6 weeks, and 18 weeks)
- ABILHAND Questionnaire(Baseline, 6 weeks, and 18 weeks)
- Revised Nottingham Sensory Assessment (rNSA)(Baseline, 6 weeks, and 18 weeks)
- Stroke Impact Scale Version 3.0 (SIS 3.0)(Baseline, 6 weeks, and 18 weeks)