"Effects of a Combined Repetitive Transcranial Magnetic Stimulation and Physical Therapy Protocol on Motor Function, Balance, and Quality of Life in Chronic Post-Stroke Hemiplegia: A Case Series"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Motor function (FMA)
研究概览
简要总结
Chronic post-stroke hemiplegia frequently results in persistent motor deficits, impaired balance, and reduced quality of life. Conventional physical therapy is fundamental for functional recovery; however, motor improvement often plateaus during the chronic phase. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique that has shown potential to enhance motor recovery by modulating cortical excitability and promoting neuroplasticity.
This case series aims to investigate the effects of a combined protocol of repetitive transcranial magnetic stimulation and conventional physical therapy on motor function, balance, and quality of life in individuals with chronic post-stroke hemiplegia. Participants will undergo rTMS applied to the motor cortex in conjunction with a structured physical therapy program. Clinical outcomes will be assessed before and after the intervention to explore feasibility, safety, and potential functional benefits of the combined approach.
详细描述
Chronic post-stroke hemiplegia is associated with persistent motor impairment, balance deficits, and reduced quality of life. Although physical therapy remains the cornerstone of rehabilitation, functional recovery frequently plateaus in the chronic phase. Strategies that enhance neuroplasticity and potentiate the effects of rehabilitation may help optimize long-term outcomes.
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique capable of modulating cortical excitability within motor networks. When applied to the motor cortex, rTMS may facilitate neuroplastic changes that support motor recovery, particularly when combined with task-oriented physical therapy.
This prospective case series investigates the feasibility, safety, and clinical effects of a combined intervention consisting of repetitive transcranial magnetic stimulation and conventional physical therapy in individuals with chronic post-stroke hemiplegia. Participants meeting predefined eligibility criteria will undergo a protocol integrating rTMS sessions with a structured physical therapy program focused on motor function, balance training, and functional mobility.
Clinical assessments will be conducted before and after completion of the intervention to evaluate changes in motor performance, balance abilities, and health-related quality of life. Safety will be monitored throughout the study, with adverse events recorded and managed in accordance with established guidelines for non-invasive brain stimulation and physical therapy.
This case series is intended to generate preliminary clinical evidence regarding the combined use of rTMS and physical therapy in the chronic post-stroke population and to inform the design of future controlled clinical trials.
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)
盲法说明
Blinding was implemented at the outcome assessment and data analysis levels. Outcome assessors responsible for administering clinical and functional tests were not involved in the intervention delivery and were unaware of group allocation. Data were anonymized and coded prior to statistical analysis, and the statistician conducted all analyses using masked group labels. Due to the nature of the transcranial stimulation intervention, care providers delivering the treatment and study investigators were not blinded.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of first-ever unilateral ischemic or hemorrhagic stroke confirmed by neuroimaging (CT or MRI)
- •Chronic post-stroke hemiplegia (≥ 6 months since stroke onset)
- •Moderate to severe motor impairment of the affected lower limb (FMA-LE score between 10 and 28 points)
- •Age between 18 and 75 years
- •Medically stable and able to participate in a rehabilitation program
- •Ability to understand study procedures and provide written informed consent
- •No contraindications to repetitive transcranial magnetic stimulation (rTMS), according to current safety guidelines.
排除标准
- •History of epilepsy or seizures
- •Presence of pacemakers, cochlear implants, intracranial metallic implants, or other contraindications to rTMS
- •Severe cognitive impairment or communication deficits preventing participation
- •Progressive neurological disorders or unstable medical conditions
- •Participation in other experimental neurorehabilitation interventions during the study period
- •Any condition judged by investigators to compromise safety or data valid
研究组 & 干预措施
rTMS Group
Participants assigned to this arm received low-frequency repetitive transcranial magnetic stimulation (rTMS) combined with task-specific physical therapy. rTMS was applied over the primary motor cortex (M1) of the unaffected hemisphere at a frequency of 1 Hz and an intensity of 90% of the individual resting motor threshold. Each session delivered 1,200 pulses over 20 minutes. Immediately after each rTMS session, participants underwent a standardized physical therapy session focused on lower-limb strengthening and balance training. This combined intervention was designed to modulate interhemispheric inhibition and facilitate motor recovery in individuals with chronic post-stroke hemiplegia.
干预措施: rTMS (Device)
rTMS Group
Participants assigned to this arm received low-frequency repetitive transcranial magnetic stimulation (rTMS) combined with task-specific physical therapy. rTMS was applied over the primary motor cortex (M1) of the unaffected hemisphere at a frequency of 1 Hz and an intensity of 90% of the individual resting motor threshold. Each session delivered 1,200 pulses over 20 minutes. Immediately after each rTMS session, participants underwent a standardized physical therapy session focused on lower-limb strengthening and balance training. This combined intervention was designed to modulate interhemispheric inhibition and facilitate motor recovery in individuals with chronic post-stroke hemiplegia.
干预措施: physical therapy (Other)
physical therapy Group
Participants assigned to this arm received a standardized physical therapy program focused on motor recovery, balance training, and functional mobility in chronic post-stroke hemiplegia. The intervention included task-specific exercises targeting the affected lower limb, muscle strengthening, postural control, and balance activities adapted to individual functional capacity. Therapy sessions were designed according to neurorehabilitation principles and progressed based on patient performance and tolerance. This arm served as a reference intervention to describe functional changes associated with conventional physical therapy in the chronic phase of stroke recovery.
干预措施: physical therapy (Other)
结局指标
主要结局
Motor function (FMA)
时间窗: Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.
Motor function was assessed using the Fugl-Meyer Assessment (FMA) for the affected upper and lower limbs. The FMA is a validated and reliable scale for evaluating motor impairment after stroke, with higher scores indicating better motor performance. The FMA has a total score ranging from 0 to 226 points (upper extremity: 0-66; lower extremity: 0-34; with additional domains contributing to the total score), with higher scores indicating better motor function. Changes in FMA scores were used to describe changes in motor function following the combined rTMS and physical therapy intervention.
balance
时间窗: Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.
Balance was assessed using the Berg Balance Scale (BBS), a validated clinical tool designed to evaluate static and dynamic balance performance in individuals after stroke. The BBS consists of 14 functional tasks commonly affected in post-stroke hemiplegia. The BBS has a total score ranging from 0 to 56 points, with higher scores indicating better balance ability. Changes in BBS scores were used to describe balance improvements following the combined rTMS and physical therapy interventio
Functional mobility
时间窗: Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.
Functional mobility was assessed using the Timed Up and Go (TUG) test. The TUG evaluates the ability to stand up from a seated position, walk, turn, and sit down, reflecting functional mobility and dynamic balance in individuals with post-stroke hemiplegia. Lower completion times indicate better functional performance. Changes in TUG time were used to describe improvements in mobility following the combined rTMS and physical therapy intervention.
次要结局
- Muscle strength (handgrip strength)(Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.)
- Quality of life SF-36(Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.)
- HADS-D(aseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.)