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

NCT06551597 | Recruiting

• 1 other identifier: Magneto1
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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

Keywords

extremely low - frequency magnetic fields therapy; stroke; rehabilitation

Outcome Measures

Primary Outcomes (5)

• Functional Independence Measure

  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.

  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

  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.

  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

  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.

  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

  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.

  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

  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).

  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 (2)

• 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)

• 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)

Study Arms (3)

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

EXPERIMENTAL

Procedure: Extremely low frequency electromagnetic fields stimulation

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

ACTIVE COMPARATOR

Procedure: Extremely low frequency electromagnetic fields stimulation

Control group - The group receiving only standard therapy

NO INTERVENTION

Interventions

Extremely low frequency electromagnetic fields stimulation 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.

MT1 - The group receiving magnetotherapy to the head in addition to standard therapy; MT2 - The group receiving magnetotherapy to the pelvis in addition to standard therapy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Neurorehabilitation Ward, Greater Poland Provincial Hospital

Poznan, Poland

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Katarzyna Hojan, Assoc Prof

  Poznan University of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Tomasz Trzmiel, PhD

CONTACT

+48 61 854-65-73; ttrzmiel@ump.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 13, 2024
• Study Start: June 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)