Remote Ischemic Conditioning for Motor Recovery After Acute Ischemic Stroke

Study 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.

Official Title
-----------------
The Safety and Efficacy of Remote Ischemic Conditioning on Motor Recovery After Acute Stroke

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Device: remote ischemic conditioning


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: remote ischemic conditioning<br>Receiving remote ischemic conditioning (RIC) treatment with pressure set at 200 mmHg. | Device: remote ischemic conditioning<br>* 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.<br>|
| Sham Comparator: placebo remote ischemic conditioning<br>Receiving sham RIPC treatment with pressure set at 60 mmHg | Device: remote ischemic conditioning<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in Fugl-Meyer score | 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 | 0-3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of the level of angiogenesis related factors | circulatory VEGF,EGF,PDGF,CD40L will be tested before and after the treatment | 0-3 months | 
| changes in Barthel Index | 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 | 0-3months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
remote ischemic conditioning