Electrically Assisted Movement Therapy (EAMT) for Upper Limb Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Fugl-Meyer Assessment of the Upper Extremity (FMA-UE),
研究概览
简要总结
The purpose of this study is to determine whether intensive, focused training of the affected upper extremity after stroke results in long-term functional gains in moderately-to-severely paralyzed patients, more than 6 months after their vascular accident. During the course of therapy, user's attempts to move and complete exercises are assisted by neuromuscular electrical stimulation.
详细描述
This pilot study quantifies functional gains induced by the Electrically Assisted Movement Therapy (EAMT), an extension of Constraint-Induced Movement Therapy to moderately-to-severely paralyzed patients in their stable plateau phase of recovery. During EAMT, patients can assist affected upper limb movements through functional electrical stimulation. Initially, patients are divided in two groups. One of the groups receives EAMT, the other receives the best possible physical and occupational therapy. Therapy consists in 40 sessions of 45 minutes twice per day over five weeks, including a one-week therapy break. After 20 sessions, group allocation is crossed-over, and patients don't receive any therapy for one week.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of one, first ever stroke (both ischemic or hemorrhagic) verified by brain imaging (MRI or CT);
- •Chronic impairment after stroke (minimum 6 months);
- •No contraindications to MRI;
- •No contraindications to electrical stimulation;
排除标准
- •Unstable recovery stage (difference between two examinations > 1 FMA-UE point);
- •Mild impairment of the upper extremity (FMA-UE >= 21);
- •Excessive spasticity of the affected arm (modified Ashworth Scale > 2);
结局指标
主要结局
Change in Fugl-Meyer Assessment of the Upper Extremity (FMA-UE),
时间窗: T0 (Before treatment); T1 (3 weeks after start and before treatment crossover); T2 (6 weeks after T0, at the end of treatment); T3 (3 months after treatment); T4 (6 months after treatment)
A quantitative measure of motor impairment.
次要结局
- Wolf Motor Function Test(T0 (Before treatment); T1 (3 weeks after start and before treatment crossover); T2 (6 weeks after T0, at the end of treatment); T3 (3 months after treatment); T4 (6 months after treatment))
- Motor Activity Log(T0 (Before treatment); at 1, 2, 3, 4, 5, 6, 18 and 30 weeks after treatment start)
- Modified Ashworth scale(T0 (Before treatment); T1 (3 weeks after start and before treatment crossover); T2 (6 weeks after T0, at the end of treatment); T3 (3 months after treatment); T4 (6 months after treatment))
- European stroke scale(T0 (Before treatment); T1 (3 weeks after start and before treatment crossover); T2 (6 weeks after T0, at the end of treatment); T3 (3 months after treatment); T4 (6 months after treatment))
研究者
Stefano Carda
MD, PhD
Centre Hospitalier Universitaire Vaudois