Ischemic Stroke
Conditions
Keywords
remote ischemic conditioning
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.
Interventions
DEVICEremote ischemic conditioning
RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on bilateral arms and inflated to design pressure for 5-min followed by deflation for 5-min, the procedures is performed repeatedly for 5 times.
Sponsors
Ji Xunming,MD,PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects aged 18-80 years; 2. First-ever unilateral ischemic stroke,5\ 10 days after onset; 3. Had motor dysfunction caused by stroke(Fugl-Meyer≤55) 4. mRS≤1 before stroke 5. NIHSS 6\ 20 6. Written consent was obtained from the subject.
Exclusion criteria
1. Cannot complete assessments-ie, psychiatric disorders, sensory aphasia, dementia 2. brainstem lesion or cerebellun lesion 3. poorly controlled diabetes mellitus 4. 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) 5. severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in Fugl-Meyer score | 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
| Measure | Time frame | Description |
|---|---|---|
| changes in Barthel Index | 0-3months | Barthel Index will be used for assessing ability of daily life, range from 0 to 100, the higher the score, the better recovery patient reach |
| Changes of the level of angiogenesis related factors | 0-3 months | circulatory VEGF,EGF,PDGF,CD40L will be tested before and after the treatment |
Countries
China
Contacts
Primary ContactXunming Ji, MD PhD
Backup ContactWantong Yu, MD
Outcome results
None listed