Remote Ischemic Conditioning for Motor Recovery After Acute Ischemic Stroke
The Safety and Efficacy of Remote Ischemic Conditioning on Motor Recovery After Acute Stroke
1 other identifier
interventional
20
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2020
CompletedStudy Start
First participant enrolled
December 31, 2021
CompletedFirst Posted
Study publicly available on registry
March 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2023
CompletedMarch 2, 2022
August 1, 2021
1 year
December 1, 2020
February 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Changes of the level of angiogenesis related factors
0-3 months
changes in Barthel Index
0-3months
Study Arms (2)
remote ischemic conditioning
EXPERIMENTALReceiving remote ischemic conditioning (RIC) treatment with pressure set at 200 mmHg.
placebo remote ischemic conditioning
SHAM COMPARATORReceiving sham RIPC treatment with pressure set at 60 mmHg
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xuan Wu Hospital,Capital Medical University
Beijing, Beijing Municipality, 100053, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xunming Ji, MD PhD
Capital Medical University Xuan Wu Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Neurosurgery, Vice-President of Xuan Wu Hospital, Capital Medical University
Study Record Dates
First Submitted
December 1, 2020
First Posted
March 2, 2022
Study Start
December 31, 2021
Primary Completion
December 31, 2022
Study Completion
January 31, 2023
Last Updated
March 2, 2022
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will share