Ischemic StrokeNCT05263531
Remote Ischemic Conditioning for Motor Recovery After Acute Ischemic Stroke
A study testing remote ischemic conditioning in people with Ischemic Stroke, run by Ji Xunming,MD,PhD at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- remote ischemic conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2021to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuan Wu Hospital,Capital Medical University
Beijing, Beijing Municipality, 100053
xunming ji, 861013120136877, jixunming@vip.163.com
About this study
Official title: The Safety and Efficacy of Remote Ischemic Conditioning on Motor Recovery After Acute Stroke
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
Read the 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
- Being tested
- remote ischemic conditioning
- Keywords
- remote ischemic conditioning
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischemic conditioningDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| remote ischemic conditioning | Experimental | Receiving remote ischemic conditioning (RIC) treatment with pressure set at 200 mmHg. Receives: Device: remote ischemic conditioning |
| placebo remote ischemic conditioning | Sham comparator | Receiving sham RIPC treatment with pressure set at 60 mmHg Receives: Device: remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-3 months
Secondary outcomes (2)
Changes of the level of angiogenesis related factors
circulatory VEGF,EGF,PDGF,CD40L will be tested before and after the treatment
Measured: 0-3 months
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
Measured: 0-3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start31 Dec 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ji Xunming,MD,PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ji Xunming,MD,PhD, Capital Medical University
- Investigators
- Xunming Ji, MD PhD, Principal investigator, Capital Medical University Xuan Wu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263531
- Sponsor's protocol ID
- RIC-MR
- Status last verified
- Aug 2021
- First submitted
- 1 Dec 2020
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Remote Ischemic Conditioning on Motor Recovery After Acute Stroke
- ClinicalTrials.gov ID
- NCT05263531
- Acronym / sponsor ID
- RIC-MR
- Conditions
- Ischemic Stroke
- Keywords
- remote ischemic conditioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ji Xunming,MD,PhDUniversity, hospital or other
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remote ischemic conditioning | Experimental | Device: remote ischemic conditioningReceiving remote ischemic conditioning (RIC) treatment with pressure set at 200 mmHg. |
| placebo remote ischemic conditioning | Sham comparator | Device: remote ischemic conditioningReceiving sham RIPC treatment with pressure set at 60 mmHg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remote ischemic conditioningRIC 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. | Device | placebo remote ischemic conditioning, remote ischemic conditioning |
Primary outcome
changes in Fugl-Meyer score
Time frame: 0-3 months
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
2 secondary outcomes
Changes of the level of angiogenesis related factors
Time frame: 0-3 months
changes in Barthel Index
Time frame: 0-3months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xunming Ji, MD PhD principal investigator
Capital Medical University Xuan Wu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remote ischemic conditioning in people with Ischemic Stroke, run by Ji Xunming,MD,PhD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xunming Ji, MD PhD (011-86-10-8319-8952, jixunming@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in Fugl-Meyer score (time frame: 0-3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.