Remote Ischemic Conditioning for Motor Recovery After Acute Ischemic Stroke

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05263531
• Other study ID #: RIC-MR
• Status: Recruiting
• Phase: N/A
• Start date: December 31, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: August 2021
• Source: Capital Medical University
• Contact: Xunming Ji, MD PhD
• Phone: 011-86-10-8319-8952
• Email: jixunming[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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,a1/a2 adrenergic receptor inhibitors,BZD,etc)

5. severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Xuan Wu Hospital,Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Ji Xunming,MD,PhD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes of the level of angiogenesis related factors	circulatory VEGF,EGF,PDGF,CD40L will be tested before and after the treatment	0-3 months
Secondary	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