A Randomized Controlled Trial on Hemiplegic Gait Rehabilitation: Robotic Locomotor Training Versus Conventional Training in Subacute Stroke.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Functional Ambulation Categories (FAC, 0-5)
研究概览
简要总结
The incidence of stroke in the industrial world is still high. Most of the patients are suffering from paresis of the affected side, speech and cognition problems. Modern concepts of motor learning after stroke favouring a task-specific repetitive high-intensity therapy approach to promote motor outcome. In the last couple of years robot-assisted therapy became an important part of modern rehabilitation after stroke. But so far there is no clear evidence that robot assisted therapy in combination with conventional therapy is more effective than conventional therapy alone to promote motor functions after stroke.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subacute first-time stroke patients(hemorrhage and ischemic)
- •Age 18-80 years.
- •Impaired Functional Ambulation Category at initial score 0-2
- •Cardiovascular stable
- •Given signed inform consent
排除标准
- •Unstable general medical condition
- •Severe malposition or fixed contracture of joint with an extension deficit of more than 30 degree
- •Any functional impairment prior to stroke
- •Can not adequately cooperate in training
- •Severe communication problems
- •Severe cognitive - perceptual deficits
结局指标
主要结局
Functional Ambulation Categories (FAC, 0-5)
时间窗: 4 weeks
Description of ambulation level of the individual patient, whether and if, how much support is needed.
Barthel index (BI, 0-100)
时间窗: 4 weeks
Assesses independence in activity of daily living
次要结局
- Berg Balance Scale (BBS, 0-56(4 weeks)
- REPAS -Muscle tone (REPAS, 0-52)(4 weeks)
研究者
Ratanapat Chanubol
Dr.
Prasat Neurological Institute