Remote Ischemic Conditioning for Motor Recovery After Acute Ischemic Stroke

NCT ID: NCT05263531

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-31
• Study Completion Date: 2023-01-31

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

remote ischemic conditioning

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

Group Type: EXPERIMENTAL

remote ischemic conditioning

Intervention Type: DEVICE

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.

placebo remote ischemic conditioning

Receiving sham RIPC treatment with pressure set at 60 mmHg

Group Type: SHAM_COMPARATOR

remote ischemic conditioning

Intervention Type: DEVICE

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.

Interventions

remote 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ji Xunming,MD,PhD

OTHER

Sponsor Role: lead

Responsible Party

Ji Xunming,MD,PhD

Professor of Neurosurgery, Vice-President of Xuan Wu Hospital, Capital Medical University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xunming Ji, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Capital Medical University Xuan Wu Hospital

Locations

Xuan Wu Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xunming Ji, MD PhD

Role: CONTACT

jixunming@vip.163.com

011-86-10-8319-8952

Wantong Yu, MD

Role: CONTACT

422189034@qq.com

861013552260818

Facility Contacts

xunming ji

Role: primary

jixunming@vip.163.com

861013120136877

Other Identifiers

RIC-MR

Identifier Type: -

Identifier Source: org_study_id