NCT02451280Unknown不适用
Unilateral vs. Bilateral Approaches to Hybrid Stroke Rehabilitation
Chang Gung Memorial Hospital5 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2015年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 72
- 试验地点
- 5
- 主要终点
- Change scores of Fugl-Meyer assessment(FMA)
研究概览
简要总结
The aim of the project is to compare the effects of unilateral hybrid therapy [unilateral robot-assisted therapy (RT)] + unilateral arm training (UAT)] and bilateral hybrid therapy [bilateral RT + bilateral arm training (BAT)] on motor function, daily function, mobility, life quality, and motor control strategy in 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
- •≥3 months onset from a first-ever unilateral stroke;
- •minimal motor criteria to receive CIT (i.e., ≥10º wrist extension and ≥ 10º extension at the thumb and any two other digits);
- •an initial FMA-UE score of 10 to 56, indicating mild to moderate and moderate to severe upper extremity motor impairment;
- •no excessive spasticity in any of the joints of the affected arm (shoulder, elbow, wrist, and fingers);
- •able to follow instructions and perform the study tasks (Mini Mental State Examination ≥ 22);
- •without upper extremity fracture within 3 months;
- •no participation in any rehabilitation experiments or drug studies during the study period; and (8) willing to provide written informed consent.
排除标准
- •acute inflammatory disease;
- •major health problems or poor physical condition that might limit participation; and (3) attend any other study in recent 3 months.
结局指标
主要结局
Change scores of Fugl-Meyer assessment(FMA)
时间窗: baseline, 3 weeks, 6 weeks, 18 weeks
次要结局
- Change scores of Functional independent measure (FIM)(baseline, 3 weeks, 6 weeks)
- Change scores of Stroke Impact Scale (SIS 3.0 version)(baseline, 3 weeks, 6 weeks, 18 weeks)
- Change scores of EuroQol Quality of Life Scale (EQ-5D)(baseline, 6 weeks)
- Change scores of Action research arm test (ARAT)(baseline, 3 weeks, 6 weeks)
- Wolf Motor Function Test (WMFT)(baseline, 6 weeks)
- Change scores of Box and block test (BBT)(baseline, 3 weeks, 6 weeks, 18 weeks)
- Change scores of Medical Research Council scale (MRC)(baseline, 3 weeks, 6 weeks)
- Change scores of Modified Ashworth scale (MAS)(baseline, 3 weeks, 6 weeks)
- Change scores of Myoton(baseline, 6 weeks)
- Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI)(baseline, 6 weeks)
- Change scores of Motor activity log (MAL)(baseline, 6 weeks, 18 weeks)
- Change scores of kinematic analysis(baseline, 6 weeks)
- Change scores of Adverse effects(baseline, 3 weeks, 6 weeks)
- Change scores of Hand strength(baseline, 3 weeks, 6 weeks)
- Change scores of ABILHAND Questionnaire(baseline, 6 weeks, 18 weeks)
- Change scores of 10-meter walking test(baseline, 6 weeks)
- Change scores of Nottingham Extended ADL Questionnaire (NEADL)(baseline, 6 weeks, 18 weeks)
- Change scores of Adelaide Activities Profile (AAP)(baseline, 6 weeks)
- Change scores of Accelerometer(baseline, 6 weeks)
- Change scores of Algometer(baseline, 6 weeks)
- Change scores of Revised Nottingham Sensory Assessment (rNSA)(baseline, 6 weeks)
研究者
研究点 (5)
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