The Effect of Extremely Low-Frequency Magnetic Field on Stroke Patients

Официальное название

The Effect of Extremely Low-Frequency Magnetic Field on Physical Fitness and Inflammatory Markers in Post-Stroke Patients

Обзор

A stroke can cause neurological deficits resulting in decreased motor, sensory, and cognitive function, as well as a decline in psychosocial functioning. Early rehabilitation following a stroke incident is of great importance, and interventions should aim for an overall improvement in patient functioning and achieving the highest possible level of independence. In recent years, there has been an emphasis on the need to regulate the inflammation that occurs after a stroke, as it may influence the improvement or deterioration of the patient's condition. Initial studies have also indicated the potential for influencing post-stroke inflammation through physical therapy procedures. In studies on the impact of magnetotherapy on inflammatory processes in post-stroke patients, magnetotherapy is usually applied to the pelvic girdle or the head area. However, the effectiveness of these two application methods has not yet been compared. In this study, investigators aim to compare the effects of magnetotherapy applied to different body areas as a complement to neurological rehabilitation. The study aims to assess the impact of magnetotherapy as a complement to neurological rehabilitation on physical fitness and inflammatory markers in post-stroke patients, to evaluate the effect of magnetotherapy as a supplement to neurological rehabilitation on physical fitness and oxidative stress markers in post-stroke patients, and to assess the differences between the effects of magnetotherapy applied to the pelvic area versus magnetotherapy applied to the head area. The participants will be divided into three groups: one will serve as the control group, while the other two will receive magnetotherapy to the head or the pelvis, respectively, as an addition to standard neurological therapy.

Вмешательства

• Процедура Extremely low frequency electromagnetic fields stimulation
  * In Group MT1, patients will undergo 10 sessions (over 10 consecutive days excluding weekends) of low-frequency magnetotherapy (exposure site - head, 40 Hz, 5 mT) as addition to standard neurological rehabilitation. * In Group MT2, patients will undergo 10 sessions (over 10 consecutive days excluding weekends) of low-frequency magnetotherapy (exposure site - pelvis, 40 Hz, 5 mT) as addition to standard neurological rehabilitation. * The control group participants will receive only neurological

Первичные конечные точки

• Functional Independence Measure [Срок оценки: The study will be conducted on the day of admission, after the series of treatments (approximately on the 14th day of stay), and at the day of discharge (approximately on the 35th day of stay)]
• Barthel Scale [Срок оценки: The study will be conducted on the day of admission, after the series of treatments (approximately on the 14th day of stay), and at the day of discharge (approximately on the 35th day of stay)]
• Tinetti Scale [Срок оценки: The study will be conducted on the day of admission, after the series of treatments (approximately on the 14th day of stay), and at the day of discharge (approximately on the 35th day of stay)]
• Berg Balance Scale [Срок оценки: The study will be conducted on the day of admission, after the series of treatments (approximately on the 14th day of stay), and at the day of discharge (approximately on the 35th day of stay)]
• Short Physical Performance Battery [Срок оценки: The study will be conducted on the day of admission, after the series of treatments (approximately on the 14th day of stay), and at the day of discharge (approximately on the 35th day of stay)]

Вторичные конечные точки (2)

• C-reactive protein [Срок оценки: The study will be conducted on the day of admission, after the series of treatments (approximately on the 14th day of stay), and at the day of discharge (approximately on the 35th day of stay)]
• Procalcitonin blood levels ng/ml [Срок оценки: The study will be conducted on the day of admission, after the series of treatments (approximately on the 14th day of stay), and at the day of discharge (approximately on the 35th day of stay)]

Критерии участия

Критерии включения

• Age ≥ 60 years
• Ischemic stroke within a maximum of two weeks prior to admission to the ward

Критерии исключения

• Severe functional impairment (FIM score < 37)
• History of previous strokes
• Other neurological diseases or other conditions that could significantly impair the patient's functioning
• Contraindications to magnetotherapy
• Inability to establish logical verbal communication with the patient
• Lack of informed consent to participate in the study

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Польша · 1 центр

• Neurorehabilitation Ward, Greater Poland Provincial Hospital — Poznan

Идентификаторы

NCT: NCT06551597 · Magneto1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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