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

P

Poznan University of Medical Sciences (PUMS)

Status

Enrolling

Conditions

Stroke

Treatments

Procedure: Extremely low frequency electromagnetic fields stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06551597
Magneto1

Details and patient eligibility

About

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.

Enrollment

210 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

210 participants in 3 patient groups

MT1 - The group receiving magnetotherapy to the head in addition to standard therapy
Experimental group
Treatment:
Procedure: Extremely low frequency electromagnetic fields stimulation
MT2 - The group receiving magnetotherapy to the pelvis in addition to standard therapy
Active Comparator group
Treatment:
Procedure: Extremely low frequency electromagnetic fields stimulation
Control group - The group receiving only standard therapy
No Intervention group

Trial contacts and locations

1

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Central trial contact

Tomasz Trzmiel, PhD

Data sourced from clinicaltrials.gov

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