Remote Ischemic Conditioning for Motor Recovery After Acute Ischemic Stroke

Not Applicable

• Conditions: Ischemic Stroke
• Interventions: Device: remote ischemic conditioning

• Registration Number: NCT05263531
• Lead Sponsor: Ji Xunming,MD,PhD

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.

Study Timeline

• Study First Submitted: 2020-12-01
• Status Verified: 2021-08
• Study Start: 2021-12-31
• Study First Submitted QC: 2022-02-27
• Last Update Submitted: 2022-02-27
• Study First Posted: 2022-03-02
• Last Update Posted: 2022-03-02
• Primary Completion: 2022-12-31
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo remote ischemic conditioning	remote ischemic conditioning	Receiving sham RIPC treatment with pressure set at 60 mmHg
remote ischemic conditioning	remote ischemic conditioning	Receiving remote ischemic conditioning (RIC) treatment with pressure set at 200 mmHg.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Changes of the level of angiogenesis related factors	0-3 months	circulatory VEGF,EGF,PDGF,CD40L will be tested before and after the treatment
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

Trial Locations

Locations (1)

Xuan Wu Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China