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.
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
Presence of cardiac pacemaker or other metal implants
Deafness, severe cognitive impairment, history of psychiatric disorders
Shoulder subluxation
Extensive skin damage on affected limbs
Parallel
Conventional Rehabilitation
Other interventionConventional 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)
DevicerTMS 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)
DeviceBFRT 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.
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.
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.
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.
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.
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.
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