Remote Ischemic Conditioning for Motor Recovery After Acute Ischemic Stroke

Ji Xunming,MD,PhD

Status: Unknown

Conditions: Ischemic Stroke

Treatments: Device: remote ischemic conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT05263531

RIC-MR

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

remote ischemic conditioning

Experimental group

Description:

Receiving remote ischemic conditioning (RIC) treatment with pressure set at 200 mmHg.

Treatment:

Device: remote ischemic conditioning

placebo remote ischemic conditioning

Sham Comparator group

Description:

Receiving sham RIPC treatment with pressure set at 60 mmHg

Treatment:

Device: remote ischemic conditioning