Robot Assisted Therapy for Acute Stroke Patients: a Comparative Study of GangTrainer GT I, Lokomat System and Conventional Physiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 120
- 试验地点
- 14
- 主要终点
- Functional Ambulation Category (FAC)
研究概览
简要总结
The GangTrainer GT I and the Lokomat have proven their effectiveness on stroke Patients, but a comparison on the same controlled study population has not been made so far. Aim of the study will not only be to establish which device will work better on acute, non ambulatory stroke Patients in terms of regain of gait ability and motor function, but also clinical matters, like the efficacy of the treatment period. As a result of the trial it should be highlighted which kind of therapy has to be suggested for Patients comparable to the study population. A significant better outcome of one device in regard to the other will suggest to use one device more than the other for future treatments.
详细描述
A total of 120 Patients will be enroled in the study and divided into 2 treatment and 1 control group. Enroled Patients will all be first supratentorial non ambulatory stroke patients (ischaemic, haemorrhagic or ICH) with a hemiparesis and stroke onset from 3 - 12 weeks.
Theywill undergo either robotic treatment with the Gangtrainer GT1 or the Lokomat in one of the 2 treatment groups for 30 minutes of gross therapy time every workday for a 8 weeks period if they are in the treatment group, or conventional physiokinetherapy for 30 minutes of gross therapy time every workday for a 8 weeks period if they are in the control group.
Primary outcome will be the Functional Ambulation Category (FAC) assessed at enrolment, after 4 weeks after 8 weeks and at 6 months follow up.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First supratentorial stroke (ischaemic, haemorrhagic or ICH) resulting in a hemiparesis
- •Interval from stroke 3 - 12 weeks
- •Non ambulatory (FAC < 3)
- •Free sitting on bedside for 1 minute, both feet on the floor, ev. holding on bedside by hands
- •Barthel Index 25 - 65
排除标准
- •Unstable cardiovascular system (in case of doubt, only after approval by a internist)
- •Manifested heart diseases like labile compensated cardiac insufficiency (NYHA III), angina pectoris, myocardial infarction 120 days before study onset, cardiomyopathy, severe cardiac arrhythmia
- •Severe joint misalignment (severe constriction of movement for hip, knee and/or ankle: more than 20° fixed hip and knee extension deficit, or more than 20° fixed plantar flexion of the ankle
- •Severe cognitive dysfunction, which does not allow for comprehension of the aims of this study
- •Severe neurological or orthopaedic diseases (like polio, Parkinson´s disease), which massively affect the mobility
- •Deep vein thrombosis
- •Severe osteoporosis
- •Malignant tumour diseases
结局指标
主要结局
Functional Ambulation Category (FAC)
时间窗: after 8 weeks
次要结局
- Medical Research Council (MRC)(after 24 weeks)
- Modified Ashworth Scale (mAS)(after 24 weeks)
- 10 metres Walking Test(after 24 weeks)
- 6 Minutes Walking Test on the Floor(after 24 weeks)
- 6 Minutes Walking Test on the Treadmill with Body Weight Support(after 24 weeks)
- modified emory Functional Ambulation Profile (meFAP)(after 24 weeks)
- Functional Ambulation Category (FAC)(after 24 weeks)
- EuroQol 5 Dimensions (EQ-5D)(after 24 weeks)
- Barthel Index (BI)(after 24 weeks)
- Rivermead Mobility Index (RMI)(after 24 weeks)
- Rivermead Visual Gait Assessment (RVGA)(after 24 weeks)