NCT02694302已完成不适用
A Multi-center, Parallel and Randomized Design Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients to Evaluate Its Efficacy, Safety and Superiority Over Conventional Gait Training
P&S Mechanics Co., Ltd.4 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2014年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 4
- 主要终点
- Functional Ambulation Category(FAC)
研究概览
简要总结
A clinical trial of robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training.
详细描述
Robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training.
Experimental group receives robot-assisted-gait-training and conventional gait training.
Active comparator group receives conventional gait training only as the same number as the experimental group.
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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age more than 19 and under 80
- •Weight under 100kg
- •Height less than 200cm
- •Able to walk independently before onset of stroke
- •Ischemic or hemorrhagic stroke patients
- •Patients with motor paralysis and gait disturbance after stroke and seeking rehabilitation treatment
- •FAC(Functional Ambulation Category) under 3 (0~2)
- •Subacute stroke patients after 3 days and before 3 months of onset
- •Be informed of the nature of the study and agreed on written consent voluntarily
- •Patients taking medications or scheduled medications due to stroke
排除标准
- •Patients with contraindications to weight bearing such as fractures, etc.
- •Uncontrolled stage 2 hypertension (systolic over 160 mmHg or diastolic more than 100mmHg) or with uncontrolled orthostatic hypotension
- •Patients with cardiopulmonary disease or other underlying diseases that can not tolerate gait training
- •Patients with severe skin damage and bedsore on wearing part of the trial device
- •Pregnant or breast-feeding
- •Participation within 30 days of the other clinical trials
- •Patients whom the investigator considers inappropriate to participate in the study
结局指标
主要结局
Functional Ambulation Category(FAC)
时间窗: 9 weeks from baseline
次要结局
- Motricity Index(MI)(9 weeks from baseline)
- 10 Meter Walk Test(10MWT)(9 weeks from baseline)
- 6 Minute Walk Test(6MWT)(9 weeks from baseline)
- Medical Research Council(MRC) Scale(9 weeks from baseline)
- Modified Ashworth Scale (MAS)(9 weeks from baseline)
- Fugl-Meyer Assessment(FMA) of Motor Recovery after Stroke(9 weeks from baseline)
- Modified Barthel Index(MBI)(9 weeks from baseline)
- National Institutes of Health Stroke Scale (NIHSS)(9 weeks from baseline)
- Beck's Depression Inventory test (BDI)(9 weeks from baseline)
- Treatment Satisfaction Survey(9 weeks from baseline)
研究者
研究点 (4)
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