The Effect of Extremely Low-Frequency Magnetic Field on Physical Fitness and Inflammatory Markers in Post-Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Berg Balance Scale
研究概览
简要总结
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.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years
- •Ischemic stroke within a maximum of two weeks prior to admission to the ward
排除标准
- •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
研究组 & 干预措施
MT1 - The group receiving magnetotherapy to the head in addition to standard therapy
干预措施: Extremely low frequency electromagnetic fields stimulation (Procedure)
MT2 - The group receiving magnetotherapy to the pelvis in addition to standard therapy
干预措施: Extremely low frequency electromagnetic fields stimulation (Procedure)
Control group - The group receiving only standard therapy
结局指标
主要结局
Berg Balance Scale
时间窗: 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)
The Berg Balance Scale is a standardized tool used to assess a person's balance through various tasks, helping to evaluate their risk of falling, with the results expressed in points. Berg balance scale scores range from 0 to 56. The lower is the score, the higher is the risk of loosing balance and fall.
Barthel Scale
时间窗: 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)
The Barthel Scale is a standardized tool used to measure a person's ability to perform basic activities of daily living independently, such as feeding, bathing, dressing, and mobility, with the results expressed in points. The score can range from 0 to 100, with 100 indicating the highest level of patient independence.
Functional Independence Measure
时间窗: 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)
The Functional Independence Measure (FIM) is a standardized tool used to assess a person's level of independence in performing daily activities, including self-care, mobility, and communication, with the results expressed in points.The total score for the FIM instrument will range between 18 and 126. he higher the score, the more independent the patient is.
Short Physical Performance Battery
时间窗: 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)
The Short Physical Performance Battery (SPPB) is a standardized tool used to assess lower extremity function through a series of tasks, including balance, walking speed, and chair stands, with the results expressed in points. The scores range from 0 (worst performance) to 12 (best performance).
Tinetti Scale
时间窗: 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)
The Tinetti Scale is a standardized assessment tool used to evaluate a person's balance and gait, helping to determine their risk of falling, with the results expressed in points. The Tinetti Scale is scored from 0 to 28 points, with lower scores indicating a higher risk of falls.
次要结局
- Procalcitonin blood levels ng/ml(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))
- C-reactive protein(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))
研究者
dr n. o zdr. Trzmiel Tomasz
Assistant professor
Poznan University of Medical Sciences