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

NCT ID: NCT06551597

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-08-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MT1 - The group receiving magnetotherapy to the head in addition to standard therapy

Group Type: EXPERIMENTAL

Extremely low frequency electromagnetic fields stimulation

Intervention Type: PROCEDURE

• 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 rehabilitation.

MT2 - The group receiving magnetotherapy to the pelvis in addition to standard therapy

Group Type: ACTIVE_COMPARATOR

Extremely low frequency electromagnetic fields stimulation

Intervention Type: PROCEDURE

• 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 rehabilitation.

Control group - The group receiving only standard therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 rehabilitation.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poznan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

dr n. o zdr. Trzmiel Tomasz

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katarzyna Hojan, Assoc Prof

Role: STUDY_DIRECTOR

Poznan University of Medical Sciences

Locations

Neurorehabilitation Ward, Greater Poland Provincial Hospital

Poznan, , Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Tomasz Trzmiel, PhD

Role: CONTACT

ttrzmiel@ump.edu.pl

+48 61 854-65-73

Facility Contacts

Katarzyna Hojan, Assoc Prof

Role: primary

khojan@ump.edu.pl

+48 61 8299 712

Other Identifiers

Magneto1

Identifier Type: -

Identifier Source: org_study_id