The Effect of Blood Flow Restriction Training Combined With Transcranial Magnetic Stimulation on … (NCT07454954) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effect of Blood Flow Restriction Training Combined With Transcranial Magnetic Stimulation on Limb Function in Hemiplegic Patients After Stroke
69 participantsStarted 2026-03-01
Plain-language summary
This randomized controlled trial aims to evaluate whether combining blood flow restriction training (BFRT) with repetitive transcranial magnetic stimulation (rTMS) improves limb function in stroke patients with hemiplegia. A total of 69 participants will be randomly assigned to three groups: conventional rehabilitation alone (control group), conventional rehabilitation plus rTMS, or conventional rehabilitation plus BFRT combined with rTMS. The intervention period is 4 weeks, with assessments conducted at baseline and at the end of treatment. The primary outcome is the change in upper extremity Fugl-Meyer Assessment (FMA-UE) score, which measures motor function recovery. Secondary outcomes include Wolf Motor Function Test, Modified Barthel Index for daily activities, Berg Balance Scale, and safety parameters such as coagulation markers and adverse events. This study will help determine whether this combined approach offers a more effective rehabilitation strategy for stroke survivors.
Who can participate
Age range
25 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of stroke (ischemic or hemorrhagic) confirmed by CT or MRI, meeting the diagnostic criteria of the 4th National Cerebrovascular Disease Conference
* First-ever stroke or recurrent stroke without residual dysfunction from prior events
* Age 25-70 years, male or female
* Stable vital signs, conscious, able to understand and follow therapist instructions
* Brunnstrom stage III or above in both upper and lower limbs
* Voluntary signed informed consent by patient or legal guardian
Exclusion Criteria:
* Presence of cardiac pacemaker or other metal implants
* Deafness, severe cognitive impairment, history of psychiatric disorders
* Shoulder subluxation
* Extensive skin damage on affected limbs
* Severe cardiac, hepatic, pulmonary, or renal insufficiency
* Coagulation disorders
* Post-stroke epilepsy
* Malignancy
* Pregnancy or lactation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Upper Extremity Fugl-Meyer Assessment (FMA-UE)
Timeframe: Baseline and 4 weeks (end of intervention)
Trial details
NCT IDNCT07454954
SponsorThe First Affiliated Hospital of Zhengzhou University