The Effect of Blood Flow Restriction Training Combined With Transcranial Magnetic Stimulation on Limb Function in Hemiplegic Patients After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 69
- 主要终点
- Change in Upper Extremity Fugl-Meyer Assessment (FMA-UE)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Conventional Rehabilitation Group
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.
干预措施: Conventional Rehabilitation (Other)
rTMS Group
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.
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
BFRT + rTMS Group
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.
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
BFRT + rTMS Group
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.
干预措施: Blood Flow Restriction Training (BFRT) (Device)
结局指标
主要结局
Change in Upper Extremity Fugl-Meyer Assessment (FMA-UE)
时间窗: 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.
次要结局
- 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)
- Change in fibrinogen levels(Screening, 4 weeks (if adverse events occur))
- ncidence of treatment-emergent adverse events(Up to 8 weeks)
研究者
Shenao Du
Research Assistant, Department of Rehabilitation Medicine
The First Affiliated Hospital of Zhengzhou University