The Safety and Efficacy of Remote Ischemic Conditioning on Motor Recovery After Acute Stroke
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ischemic Stroke
- Sponsor
- Ji Xunming,MD,PhD
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- changes in Fugl-Meyer score
- Last Updated
- 4 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Ji Xunming,MD,PhD
Professor of Neurosurgery, Vice-President of Xuan Wu Hospital, Capital Medical University
Capital Medical University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
changes in Fugl-Meyer score
Time Frame: 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
Secondary Outcomes
- Changes of the level of angiogenesis related factors(0-3 months)
- changes in Barthel Index(0-3months)