StrokeBFR-TMS-StrokeNCT07454954
The Effect of Blood Flow Restriction Training Combined With Transcranial Magnetic Stimulation on Limb Function in Hemiplegic Patients After Stroke
A study testing Conventional Rehabilitation, Repetitive Transcranial Magnetic Stimulation (rTMS) and Blood Flow Restriction Training (BFRT) in people with Stroke and Hemiplegia, run by The First Affiliated Hospital of Zhengzhou University.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Stroke, Hemiplegia
- What is being tested?
- Conventional Rehabilitation, Repetitive Transcranial Magnetic Stimulation (rTMS) and Blood Flow Restriction Training (BFRT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Post-stroke epilepsy
- Malignancy
- Pregnancy or lactation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
Background: Stroke is a leading cause of long-term disability worldwide, with over two-thirds of survivors experiencing persistent limb motor dysfunction. Current rehabilitation approaches have limitations in efficacy and accessibility. Blood flow restriction training (BFRT) has shown promise in enhancing muscle strength with low-intensity exercise, while repetitive transcranial magnetic stimulation (rTMS) can modulate cortical excitability. The combination of these two modalities may produce synergistic effects on motor recovery after stroke.
Objective: This study aims to investigate the effects of BFRT combined with rTMS on upper and lower limb function, muscle strength, balance, and daily living activities in stroke patients with hemiplegia. The primary hypothesis is that the combination therapy will result in greater improvement in upper limb motor function compared to rTMS alone or conventional rehabilitation alone.
Study Design: This is a single-center, randomized, assessor-blind, parallel-group, superiority trial conducted at the Department of Rehabilitation Medicine, First Affiliated Hospital of Zhengzhou University.
Participants: A total of 69 eligible stroke patients with hemiplegia will be enrolled. Inclusion criteria include: confirmed stroke by CT or MRI, age 25-70 years, Brunnstrom stage III or above in both upper and lower limbs, stable vital signs, and ability to understand instructions. Exclusion criteria include: cardiac pacemaker or metal implants, severe cognitive impairment, shoulder subluxation, coagulation disorders, post-stroke epilepsy, and severe organ dysfunction.
Randomization and Blinding: Participants will be randomly assigned in a 1:1:1 ratio to three groups using a random number table generated by an independent researcher. The allocation sequence will be concealed. Outcome assessors and data analysts will be blinded to group assignments. Due to the nature of the interventions, participants and intervention providers cannot be blinded.
Interventions:
Group A (Control): Conventional rehabilitation including medication management, proper positioning, transfer training, conventional limb exercises, physical therapy, and muscle strength training. 30 minutes per session, twice daily, 5 days per week for 4 weeks.
Group B (rTMS): Conventional rehabilitation plus rTMS applied to the M1 area of the affected hemisphere. Stimulation parameters: 10Hz frequency, 90% resting motor threshold, 1200 pulses per session, 15 minutes per session, once daily, 5 days per week for 4 weeks.
Group C (BFRT+rTMS): Conventional rehabilitation plus rTMS (as in Group B) plus BFRT. BFRT is applied using pneumatic cuffs at 60% of arm systolic blood pressure (or limb occlusion pressure) with intermittent occlusion (5 minutes on, 1 minute off) during the same resistance training exercises as Group A. Frequency: 5 days per week for 4 weeks.
Outcome Measures:
Primary Outcome: Change in upper extremity Fugl-Meyer Assessment (FMA-UE) score from baseline to week 4. FMA-UE assesses motor function, reflex activity, and coordination, with scores ranging from 0 to 66 (higher scores indicate better function).
Secondary Outcomes: Changes in Wolf Motor Function Test (WMFT), Modified Barthel Index (MBI), Berg Balance Scale (BBS), root mean square of surface electromyography (sEMG), and safety parameters including D-dimer, fibrinogen, blood pressure, heart rate, and adverse events. All secondary outcomes are assessed at baseline and week 4.
Sample Size Calculation: Based on G*Power software using repeated measures ANOVA (group × time interaction), with effect size f=0.25, α=0.05, power=90%, 3 groups, 2 measurements, and correlation among repeated measures of 0.5, the calculated total sample size is 54. Accounting for a 20% dropout rate, the final sample size is 69 participants (23 per group).
Statistical Analysis: Primary analysis will be performed on the intention-to-treat (ITT) population using analysis of covariance (ANCOVA) with baseline FMA-UE score, age, and disease duration as covariates. Secondary outcomes will be analyzed using repeated measures ANOVA or non-parametric tests as appropriate. Safety data will be summarized descriptively.
Ethical Considerations: This study will be conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of First Affiliated Hospital of Zhengzhou University. Written informed consent will be obtained from all participants or their legal guardians before enrollment.
- Conditions
- Stroke, Hemiplegia
- Being tested
- Conventional Rehabilitation, Repetitive Transcranial Magnetic Stimulation (rTMS), Blood Flow Restriction Training (BFRT)
- Keywords
- Stroke, Hemiplegia, Blood Flow Restriction Training, Transcranial Magnetic Stimulation, rTMS, BFR Training, Motor Function, Rehabilitation, Upper Extremity, Randomized Controlled Trial
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional RehabilitationOther
Conventional rehabilitation includes medication management, proper positioning (supine, healthy side lying, affected side lying), transfer training (lateral transfer, turning, sitting up), conventional upper and lower limb exercises (anti-spasm exercises, isolated movement training, inhibition of flexion spasm of metacarpophalangeal joints and ankle joints), passive movement, techniques to induce active muscle contraction, physical therapy (low-frequency stimulation, medium-frequency stimulation, ultrashort wave, electroacupuncture), and muscle strength training (shoulder flexion, extension, adduction, abduction, internal/external rotation, elbow flexion/extension for upper limbs; hip abduction, quadriceps stretching, quadriceps press, squats, straight leg raise for lower limbs). Duration: 30 minutes per session, twice daily, 5 days per week for 4 weeks.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
rTMS is applied to the M1 area of the affected hemisphere. The resting motor threshold (RMT) is determined first. Stimulation parameters: frequency 10 Hz, intensity 90% RMT, 1200 pulses per session, 15 minutes per session, once daily, 5 days per week for 4 weeks. Device: Magstim Rapid2 or similar transcranial magnetic stimulator.
Blood Flow Restriction Training (BFRT)Device
BFRT is performed using pneumatic cuffs (arm cuff: 68×7.5 cm; leg cuff: 109×10 cm) with a pressure display. Before first use, a warm-up of five cycles of inflation/deflation to 100 mmHg (20 sec inflation, 9 sec deflation) is conducted. Pressure is set at 60% of arm systolic blood pressure (SBP) for the upper limb, applied 2 cm below the axilla; for the lower limb, pressure is set at 60% of limb occlusion pressure, applied at the proximal thigh. During occlusion, patients perform the same resistance training exercises as described in Conventional Rehabilitation (shoulder and quadriceps exercises). Occlusion pattern: 5 minutes of occlusion followed by 1 minute of release. Training frequency: 5 days per week for 4 weeks. Device: BFR training system by Theratools or similar.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Rehabilitation Group | Active comparator | Participants receive conventional rehabilitation including medication management, proper positioning, transfer training, conventional upper and lower limb exercises (anti-spasm, isolated movement training), physical therapy, and muscle strength training. Interventions are administered 30 minutes per session, twice daily, 5 days per week for 4 weeks. Receives: Other: Conventional Rehabilitation |
| rTMS Group | Experimental | In addition to conventional rehabilitation as described in Arm A, participants receive repetitive transcranial magnetic stimulation (rTMS). Stimulation is applied to the M1 area of the affected hemisphere at 90% of resting motor threshold (RMT), with frequency of 10Hz, 1200 pulses per session, 15 minutes per session, once daily, 5 days per week for 4 weeks. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| BFRT + rTMS Group | Experimental | In addition to conventional rehabilitation and rTMS as described in Arm B, participants receive blood flow restriction training (BFRT). BFRT is applied using pneumatic cuffs at 60% of arm systolic blood pressure (or limb occlusion pressure). The resistance training protocol is identical to Arm A (shoulder and quadriceps exercises). Training pattern: 5 minutes of occlusion followed by 1 minute of release. Frequency: 5 days per week for 4 weeks. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Device: Blood Flow Restriction Training (BFRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Upper Extremity Fugl-Meyer Assessment (FMA-UE)
FMA-UE is a stroke-specific, performance-based measure of upper limb motor impairment. It assesses reflex activity, movement control, and muscle strength in the shoulder, elbow, forearm, wrist, and hand. Total score ranges from 0 to 66, with higher scores indicating better motor function.
Measured: Baseline and 4 weeks (end of intervention)
Secondary outcomes (7)
Change in Wolf Motor Function Test (WMFT) score
The Wolf Motor Function Test is a timed and functional ability-based measure of upper extremity motor ability. It consists of 15 timed tasks and 2 strength tasks. For timed tasks, scores range from 0 to 120 seconds, with lower scores indicating better function. For functional ability, scores range from 0 to 5, with higher scores indicating better movement quality.
Measured: Baseline, 4 weeks
Change in Modified Barthel Index (MBI)
The Modified Barthel Index is a measure of independence in activities of daily living, including feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfers, mobility, and stairs. Total score ranges from 0 to 100, with higher scores indicating greater independence.
Measured: Baseline, 4 weeks
Change in root mean square (RMS) of surface electromyography (sEMG)
Surface electromyography (sEMG) records the electrical activity of muscles during contraction. The root mean square (RMS) value reflects the amplitude of muscle activation, measured in microvolts (μV). Higher RMS values indicate greater muscle recruitment and activation. Measurements are taken from key upper and lower limb muscles during standardized maximal voluntary contractions. Changes from baseline to week 4 are reported.
Measured: Baseline, 4 weeks
Change in Berg Balance Scale (BBS) score
The Berg Balance Scale is a 14-item measure of static and dynamic balance ability in adults. Each item is scored from 0 to 4, with a total score ranging from 0 to 56. Higher scores indicate better balance and lower fall risk. Changes from baseline to week 4 are reported.
Measured: Baseline, 4 weeks
Change in D-dimer levels
D-dimer is a fibrin degradation product present in blood after a blood clot is degraded by fibrinolysis. It is measured in mg/L or μg/L FEU (fibrinogen equivalent units). Elevated levels may indicate thrombosis, which is a potential safety concern for blood flow restriction training. Normal reference range is typically <0.5 mg/L. Values are assessed at screening and at week 4 (or when adverse events occur) to monitor for thrombotic events.
Measured: Screening, 4 weeks (if adverse events occur
Change in fibrinogen levels
Fibrinogen is a glycoprotein synthesized by the liver that plays a key role in blood coagulation. It is measured in g/L. Normal reference range is typically 2.0-4.0 g/L. Changes in fibrinogen levels are monitored as a safety measure for potential coagulation abnormalities related to blood flow restriction training. Values are assessed at screening and at week 4 (or when adverse events occur).
Measured: Screening, 4 weeks (if adverse events occur)
ncidence of treatment-emergent adverse events
An adverse event (AE) is any untoward medical occurrence in a participant administered the study interventions, which does not necessarily have a causal relationship with the interventions. Treatment-emergent adverse events are those that occur or worsen after the start of the intervention. All AEs are recorded and assessed for severity (mild, moderate, severe) and relationship to the study interventions (unrelated, possibly related, probably related, definitely related). Serious adverse events (SAEs) are defined as any event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or requires intervention to prevent permanent impairment or damage. Incidence rates are reported for all AEs, SAEs, and AEs leading to discontinuation. Safety monitoring continues throughout the 4-week intervention period and 4-week follow-up (total 8 weeks).
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shenao Du, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454954
- Sponsor's protocol ID
- 2025-KY-1992-002
- Acronym
- BFR-TMS-Stroke
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study is a single-center exploratory trial with a small sample size, and the informed consent obtained from participants did not include provisions for data sharing with external researchers. Additionally, there are no dedicated resources to prepare and maintain anonymized datasets for public sharing.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Blood Flow Restriction Training Combined With Transcranial Magnetic Stimulation on Limb Function in Hemiplegic Patients After Stroke
- ClinicalTrials.gov ID
- NCT07454954
- Acronym / sponsor ID
- BFR-TMS-Stroke / 2025-KY-1992-002
- Conditions
- Stroke, Hemiplegia
- Keywords
- Stroke, Hemiplegia, Blood Flow Restriction Training, Transcranial Magnetic Stimulation, rTMS, BFR Training, Motor Function, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 6 Mar 2026 (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.
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.
Detailed description
Background: Stroke is a leading cause of long-term disability worldwide, with over two-thirds of survivors experiencing persistent limb motor dysfunction. Current rehabilitation approaches have limitations in efficacy and accessibility. Blood flow restriction training (BFRT) has shown promise in enhancing muscle strength with low-intensity exercise, while repetitive transcranial magnetic stimulation (rTMS) can modulate cortical excitability. The combination of these two modalities may produce synergistic effects on motor recovery after stroke.
Objective: This study aims to investigate the effects of BFRT combined with rTMS on upper and lower limb function, muscle strength, balance, and daily living activities in stroke patients with hemiplegia. The primary hypothesis is that the combination therapy will result in greater improvement in upper limb motor function compared to rTMS alone or conventional rehabilitation alone.
Study Design: This is a single-center, randomized, assessor-blind, parallel-group, superiority trial conducted at the Department of Rehabilitation Medicine, First Affiliated Hospital of Zhengzhou University.
Participants: A total of 69 eligible stroke patients with hemiplegia will be enrolled. Inclusion criteria include: confirmed stroke by CT or MRI, age 25-70 years, Brunnstrom stage III or above in both upper and lower limbs, stable vital signs, and ability to understand instructions. Exclusion criteria include: cardiac pacemaker or metal implants, severe cognitive impairment, shoulder subluxation, coagulation disorders, post-stroke epilepsy, and severe organ dysfunction.
Randomization and Blinding: Participants will be randomly assigned in a 1:1:1 ratio to three groups using a random number table generated by an independent researcher. The allocation sequence will be concealed. Outcome assessors and data analysts will be blinded to group assignments. Due to the nature of the interventions, participants and intervention providers cannot be blinded.
Interventions:
Group A (Control): Conventional rehabilitation including medication management, proper positioning, transfer training, conventional limb exercises, physical therapy, and muscle strength training. 30 minutes per session, twice daily, 5 days per week for 4 weeks.
Group B (rTMS): Conventional rehabilitation plus rTMS applied to the M1 area of the affected hemisphere. Stimulation parameters: 10Hz frequency, 90% resting motor threshold, 1200 pulses per session, 15 minutes per session, once daily, 5 days per week for 4 weeks.
Group C (BFRT+rTMS): Conventional rehabilitation plus rTMS (as in Group B) plus BFRT. BFRT is applied using pneumatic cuffs at 60% of arm systolic blood pressure (or limb occlusion pressure) with intermittent occlusion (5 minutes on, 1 minute off) during the same resistance training exercises as Group A. Frequency: 5 days per week for 4 weeks.
Outcome Measures:
Primary Outcome: Change in upper extremity Fugl-Meyer Assessment (FMA-UE) score from baseline to week 4. FMA-UE assesses motor function, reflex activity, and coordination, with scores ranging from 0 to 66 (higher scores indicate better function).
Secondary Outcomes: Changes in Wolf Motor Function Test (WMFT), Modified Barthel Index (MBI), Berg Balance Scale (BBS), root mean square of surface electromyography (sEMG), and safety parameters including D-dimer, fibrinogen, blood pressure, heart rate, and adverse events. All secondary outcomes are assessed at baseline and week 4.
Sample Size Calculation: Based on G*Power software using repeated measures ANOVA (group × time interaction), with effect size f=0.25, α=0.05, power=90%, 3 groups, 2 measurements, and correlation among repeated measures of 0.5, the calculated total sample size is 54. Accounting for a 20% dropout rate, the final sample size is 69 participants (23 per group).
Statistical Analysis: Primary analysis will be performed on the intention-to-treat (ITT) population using analysis of covariance (ANCOVA) with baseline FMA-UE score, age, and disease duration as covariates. Secondary outcomes will be analyzed using repeated measures ANOVA or non-parametric tests as appropriate. Safety data will be summarized descriptively.
Ethical Considerations: This study will be conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of First Affiliated Hospital of Zhengzhou University. Written informed consent will be obtained from all participants or their legal guardians before enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Rehabilitation Group | Active comparator | Other: Conventional RehabilitationParticipants receive conventional rehabilitation including medication management, proper positioning, transfer training, conventional upper and lower limb exercises (anti-spasm, isolated movement training), physical therapy, and muscle strength training. Interventions are administered 30 minutes per session, twice daily, 5 days per week for 4 weeks. |
| rTMS Group | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)In addition to conventional rehabilitation as described in Arm A, participants receive repetitive transcranial magnetic stimulation (rTMS). Stimulation is applied to the M1 area of the affected hemisphere at 90% of resting motor threshold (RMT), with frequency of 10Hz, 1200 pulses per session, 15 minutes per session, once daily, 5 days per week for 4 weeks. |
| BFRT + rTMS Group | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Device: Blood Flow Restriction Training (BFRT)In addition to conventional rehabilitation and rTMS as described in Arm B, participants receive blood flow restriction training (BFRT). BFRT is applied using pneumatic cuffs at 60% of arm systolic blood pressure (or limb occlusion pressure). The resistance training protocol is identical to Arm A (shoulder and quadriceps exercises). Training pattern: 5 minutes of occlusion followed by 1 minute of release. Frequency: 5 days per week for 4 weeks. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Conventional RehabilitationConventional rehabilitation includes medication management, proper positioning (supine, healthy side lying, affected side lying), transfer training (lateral transfer, turning, sitting up), conventional upper and lower limb exercises (anti-spasm exercises, isolated movement training, inhibition of flexion spasm of metacarpophalangeal joints and ankle joints), passive movement, techniques to induce active muscle contraction, physical therapy (low-frequency stimulation, medium-frequency stimulation, ultrashort wave, electroacupuncture), and muscle strength training (shoulder flexion, extension, adduction, abduction, internal/external rotation, elbow flexion/extension for upper limbs; hip abduction, quadriceps stretching, quadriceps press, squats, straight leg raise for lower limbs). Duration: 30 minutes per session, twice daily, 5 days per week for 4 weeks. | Other | Conventional Rehabilitation Group |
| Repetitive Transcranial Magnetic Stimulation (rTMS)rTMS is applied to the M1 area of the affected hemisphere. The resting motor threshold (RMT) is determined first. Stimulation parameters: frequency 10 Hz, intensity 90% RMT, 1200 pulses per session, 15 minutes per session, once daily, 5 days per week for 4 weeks. Device: Magstim Rapid2 or similar transcranial magnetic stimulator. | Device | BFRT + rTMS Group, rTMS Group |
| Blood Flow Restriction Training (BFRT)BFRT is performed using pneumatic cuffs (arm cuff: 68×7.5 cm; leg cuff: 109×10 cm) with a pressure display. Before first use, a warm-up of five cycles of inflation/deflation to 100 mmHg (20 sec inflation, 9 sec deflation) is conducted. Pressure is set at 60% of arm systolic blood pressure (SBP) for the upper limb, applied 2 cm below the axilla; for the lower limb, pressure is set at 60% of limb occlusion pressure, applied at the proximal thigh. During occlusion, patients perform the same resistance training exercises as described in Conventional Rehabilitation (shoulder and quadriceps exercises). Occlusion pattern: 5 minutes of occlusion followed by 1 minute of release. Training frequency: 5 days per week for 4 weeks. Device: BFR training system by Theratools or similar. | Device | BFRT + rTMS Group |
Primary outcome
Change in Upper Extremity Fugl-Meyer Assessment (FMA-UE)
Time frame: Baseline and 4 weeks (end of intervention)
FMA-UE is a stroke-specific, performance-based measure of upper limb motor impairment. It assesses reflex activity, movement control, and muscle strength in the shoulder, elbow, forearm, wrist, and hand. Total score ranges from 0 to 66, with higher scores indicating better motor function.
7 secondary outcomes
Change in Wolf Motor Function Test (WMFT) score
Time frame: Baseline, 4 weeks
Change in Modified Barthel Index (MBI)
Time frame: Baseline, 4 weeks
Change in root mean square (RMS) of surface electromyography (sEMG)
Time frame: Baseline, 4 weeks
Change in Berg Balance Scale (BBS) score
Time frame: Baseline, 4 weeks
Change in D-dimer levels
Time frame: Screening, 4 weeks (if adverse events occur
Change in fibrinogen levels
Time frame: Screening, 4 weeks (if adverse events occur)
ncidence of treatment-emergent adverse events
Time frame: Up to 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study is a single-center exploratory trial with a small sample size, and the informed consent obtained from participants did not include provisions for data sharing with external researchers. Additionally, there are no dedicated resources to prepare and maintain anonymized datasets for public sharing.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Rehabilitation, Repetitive Transcranial Magnetic Stimulation (rTMS) and Blood Flow Restriction Training (BFRT) in people with Stroke and Hemiplegia, run by The First Affiliated Hospital of Zhengzhou University.
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 9 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: opening soon, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shenao Du (+86 18338275745, 18338275745@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Upper Extremity Fugl-Meyer Assessment (FMA-UE) (time frame: Baseline and 4 weeks (end of intervention)). 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 6 Mar 2026.