StrokeNCT06551597
The Effect of Extremely Low-Frequency Magnetic Field on Stroke Patients
A study testing Extremely low frequency electromagnetic fields stimulation in people with Stroke, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Extremely low frequency electromagnetic fields stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2024to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years
- Ischemic stroke within a maximum of two weeks prior to admission to the ward
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Neurorehabilitation Ward, Greater Poland Provincial Hospital
Poznan
Katarzyna Hojan, Assoc Prof, +48 61 8299 712, khojan@ump.edu.pl
About this study
Official title: The Effect of Extremely Low-Frequency Magnetic Field on Physical Fitness and Inflammatory Markers in Post-Stroke Patients
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
- Being tested
- Extremely low frequency electromagnetic fields stimulation
- Keywords
- extremely low - frequency magnetic fields therapy, stroke, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extremely low frequency electromagnetic fields stimulationProcedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| MT1 - The group receiving magnetotherapy to the head in addition to standard therapy | Experimental | Not described Receives: Procedure: Extremely low frequency electromagnetic fields stimulation |
| MT2 - The group receiving magnetotherapy to the pelvis in addition to standard therapy | Active comparator | Not described Receives: Procedure: Extremely low frequency electromagnetic fields stimulation |
| Control group - The group receiving only standard therapy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
C-reactive protein (CRP) is a blood test used to measure the level of inflammation in the body, which can indicate the presence and severity of infection or other inflammatory conditions, with the results expressed in milligrams per liter (mg/L)
Measured: 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
Procalcitonin is a blood test used to assess the level of procalcitonin, a biomarker that helps indicate the presence and severity of bacterial infections, particularly sepsis. It is also an important marker of the inflammatory process and oxidative stress in stroke patients, with the results expressed in nanograms per milliliter (ng/mL).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Jun 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr n. o zdr. Trzmiel Tomasz, Poznan University of Medical Sciences
- Investigators
- Katarzyna Hojan, Assoc Prof, Study director, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551597
- Sponsor's protocol ID
- Magneto1
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Extremely Low-Frequency Magnetic Field on Physical Fitness and Inflammatory Markers in Post-Stroke Patients
- ClinicalTrials.gov ID
- NCT06551597
- Acronym / sponsor ID
- Magneto1
- Conditions
- Stroke
- Keywords
- extremely low - frequency magnetic fields therapy, stroke, rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 60 years
- Ischemic stroke within a maximum of two weeks prior to admission to the ward
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | 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 |
Primary outcome
Functional Independence Measure
Time frame: 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.
Barthel Scale
Time frame: 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.
Tinetti Scale
Time frame: 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.
Berg Balance Scale
Time frame: 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.
Short Physical Performance Battery
Time frame: 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).
2 secondary outcomes
C-reactive protein
Time frame: 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
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katarzyna Hojan, Assoc Prof study director
Poznan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extremely low frequency electromagnetic fields stimulation in people with Stroke, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tomasz Trzmiel, PhD (+48 61 854-65-73, ttrzmiel@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Independence Measure (time frame: 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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.