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

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

Interventions

OTHER

Conventional Rehabilitation

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.

DEVICE

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

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.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-01

Primary Completion

2026-09-01

Completion

2027-03-31