The Effect of Blood Flow Restriction Training Combined With Transcranial Magnetic Stimulation on Limb Function in Hemiplegic Patients After Stroke

NCT07454954 | Not Yet Recruiting

• 1 other identifier: 2025-KY-1992-002
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stroke; Hemiplegia

Keywords

Stroke; Hemiplegia; Blood Flow Restriction Training; Transcranial Magnetic Stimulation; rTMS; BFR Training; Motor Function; Rehabilitation; Upper Extremity; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 4 weeks (end of intervention)

Secondary Outcomes (7)

• Change in Wolf Motor Function Test (WMFT) score

  Baseline, 4 weeks

• Change in Modified Barthel Index (MBI)

  Baseline, 4 weeks

• Change in root mean square (RMS) of surface electromyography (sEMG)

  Baseline, 4 weeks

• Change in Berg Balance Scale (BBS) score

  Baseline, 4 weeks

• Change in D-dimer levels

  Screening, 4 weeks (if adverse events occur

Study Arms (3)

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.

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.

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.

Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Device: Blood Flow Restriction Training (BFRT)

Interventions

Conventional Rehabilitation OTHER

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.

Conventional Rehabilitation Group

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.

BFRT + rTMS Group; rTMS Group

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.

BFRT + rTMS Group

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

MeSH Terms

Conditions

Stroke; Hemiplegia

Interventions

Transcranial Magnetic Stimulation; Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Therapy Modalities

Central Study Contacts

Shenao Du

CONTACT

+86 18338275745; 18338275745@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Department of Rehabilitation Medicine

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 6, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share