Remote Ischemic Conditioning for Motor Recovery After Acute Ischemic Stroke
Primary Purpose
Ischemic Stroke
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
remote ischemic conditioning
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring remote ischemic conditioning
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.
Sites / Locations
- Xuan Wu Hospital,Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
remote ischemic conditioning
placebo remote ischemic conditioning
Arm Description
Receiving remote ischemic conditioning (RIC) treatment with pressure set at 200 mmHg.
Receiving sham RIPC treatment with pressure set at 60 mmHg
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Changes of the level of angiogenesis related factors
circulatory VEGF,EGF,PDGF,CD40L will be tested before and after the treatment
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05263531
Brief Title
Remote Ischemic Conditioning for Motor Recovery After Acute Ischemic Stroke
Official Title
The Safety and Efficacy of Remote Ischemic Conditioning on Motor Recovery After Acute Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 31, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ji Xunming,MD,PhD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
remote ischemic conditioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
remote ischemic conditioning
Arm Type
Experimental
Arm Description
Receiving remote ischemic conditioning (RIC) treatment with pressure set at 200 mmHg.
Arm Title
placebo remote ischemic conditioning
Arm Type
Sham Comparator
Arm Description
Receiving sham RIPC treatment with pressure set at 60 mmHg
Intervention Type
Device
Intervention Name(s)
remote ischemic conditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
changes in Fugl-Meyer score
Description
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
Time Frame
0-3 months
Secondary Outcome Measure Information:
Title
Changes of the level of angiogenesis related factors
Description
circulatory VEGF,EGF,PDGF,CD40L will be tested before and after the treatment
Time Frame
0-3 months
Title
changes in Barthel Index
Description
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
Time Frame
0-3months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xunming Ji, MD PhD
Phone
011-86-10-8319-8952
Email
jixunming@vip.163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wantong Yu, MD
Phone
861013552260818
Email
422189034@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xunming Ji, MD PhD
Organizational Affiliation
Capital Medical University Xuan Wu Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuan Wu Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xunming ji
Phone
861013120136877
Email
jixunming@vip.163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Remote Ischemic Conditioning for Motor Recovery After Acute Ischemic Stroke
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