The Safety and Efficacy of Remote Ischemic Conditioning on Motor Recovery After Acute Stroke
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- changes in Fugl-Meyer score
研究概览
简要总结
The most recent treatment for stroke rehabilitation is to combine physical training with other therapies to enhance or accelerate recovery.The hypothesis of this study is that remote ischemic conditioning (RIC) might have a beneficial effect on motor recovery of AIS
详细描述
Despite the effective reperfusion therapies ,acute ischemic stroke(AIS) is still one of the leading causes of disability, resulting in an economic burden. Multidisciplinary rehabilitation has benefit effects on motor recovery and remains the first-line intervention strategy for attenuating motor function impairments. However, the effect of the physiotherapy application alone is not satisfactory, The potential treatment effect of RIC on motor recovery of AIS has not been investigated. The investigators designed this randomized clinical trial to examine whether RIC has a beneficial effect on poststroke motor function recovery.There are 2 arms in this trial: One arm is RIC treatment, the other one is sham RIC treatment. The motor function will be assessed by Fugl-Meyer Motor Scale before and after the treatment to evaluate its exact effect on motor recovery.
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
- None
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
- •Subjects aged 18-80 years;
- •First-ever unilateral ischemic stroke,5~10 days after onset;
- •Had motor dysfunction caused by stroke(Fugl-Meyer≤55)
- •mRS≤1 before stroke
- •NIHSS 6~20
- •Written consent was obtained from the subject.
排除标准
- •Cannot complete assessments-ie, psychiatric disorders, sensory aphasia, dementia
- •brainstem lesion or cerebellun lesion
- •poorly controlled diabetes mellitus
- •Application of agent which thought to impair or improve recovery based on laboratory and clinical evidence within 1 month (ie,DA,MAOI, SSRI,α1/α2 adrenergic receptor inhibitors,BZD,etc)
- •severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.
结局指标
主要结局
changes in Fugl-Meyer score
时间窗: 0-3 months
Fugl-Meyer scale assessment (FMA) will be used for assessing improvement of motor function. Total score of FMA range from 0 to 100, a score of 100 means full recovery of motor function
次要结局
- Changes of the level of angiogenesis related factors(0-3 months)
- changes in Barthel Index(0-3months)
研究者
Ji Xunming,MD,PhD
Professor of Neurosurgery, Vice-President of Xuan Wu Hospital, Capital Medical University
Capital Medical University