"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"

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство rTMS
  Repetitive transcranial magnetic stimulation (rTMS) was delivered using low-frequency stimulation applied over the primary motor cortex. Stimulation parameters were individually adjusted based on the resting motor threshold and kept constant across sessions. Coil positioning and stimulation conditions were standardized to ensure reproducibility. Safety screening was conducted prior to stimulation sessions, and adverse events were monitored throughout the intervention period in accordance with es
• Другое physical therapy
  The physical therapy intervention consisted of a structured, task-oriented rehabilitation approach targeting motor control, balance, and functional mobility. Exercises were selected to promote activation of the affected limb, postural control, and functional movement patterns. The intervention followed standardized neurorehabilitation principles, with progressive adaptation of tasks based on individual performance and tolerance.

Первичные конечные точки

• Motor function (FMA) [Срок оценки: Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.]
• balance [Срок оценки: Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.]
• Functional mobility [Срок оценки: Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.]

Вторичные конечные точки (2)

• Muscle strength (handgrip strength) [Срок оценки: Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.]
• Quality of life SF-36 [Срок оценки: Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07597746 · Sierra Varona SL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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