Clinical trial NCT06551597: The Effect of Extremely Low-Frequency Magnetic Field on Stroke Patients
Official title: The Effect of Extremely Low-Frequency Magnetic Field on Physical Fitness and Inflammatory Markers in Post-Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: extremely low - frequency magnetic fields therapy
stroke
rehabilitation
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 210
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Functional Independence Measure
timeFrame: 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)
measure: Barthel Scale
timeFrame: 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)
measure: Tinetti Scale
timeFrame: 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)
measure: Berg Balance Scale
timeFrame: 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)
measure: Short Physical Performance Battery
timeFrame: 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)
Secondary outcomes:
measure: C-reactive protein
timeFrame: 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)
measure: Procalcitonin blood levels ng/ml
timeFrame: 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)
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Neurorehabilitation Ward, Greater Poland Provincial Hospital
Study officials:
affiliation: Poznan University of Medical Sciences
name: Katarzyna Hojan, Assoc Prof
role: STUDY_DIRECTOR
References: