Multiple SclerosisNCT07646912
Effect of High-Intensity Focused Electromagnetic Therapy on Balance and Quality of Life in Patients With Multiple Sclerosis
A study testing High-Intensity Focused Electromagnetic Therapy and Balance Exercises in people with Multiple Sclerosis, run by Middle East University.
Trial summary
Evaluate the effect of High-Intensity Focused Electromagnetic Therapy on dynamic balance, fall risk, core muscle function, and quality of life in patients with multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- High-Intensity Focused Electromagnetic Therapy and Balance Exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 22 Jun 2026to 14 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Confirmed clinical diagnosis of Multiple Sclerosis according to the revised McDonald criteria.
- Expanded Disability Status Scale score range between 3.0 and 5.5.
- Clinically stable condition with no neurological relapses or corticosteroid therapy within the past 3 months.
Who cannot join
- Presence of pacemakers, internal defibrillators, or metallic implants in the torso/abdominal region.
- Severe cognitive impairment interfering with the understanding of instructions or questionnaires.
- Other concomitant neurological or musculoskeletal orthopedic conditions that independently affect balance or gait.
- Severe visual deficits or uncorrected vestibular disorders.
- Pregnancy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mohammed Youssef Elhamrawy, Ph.D contact
About this study
Official title: Effect of High-Intensity Focused Electromagnetic Technology on Balance and Quality of Life in Patients With Multiple Sclerosis: A Randomized Controlled Trial
Evaluate the effect of High-Intensity Focused Electromagnetic Therapy on dynamic balance, fall risk, core muscle function, and quality of life in patients with multiple sclerosis.
Read the detailed description
Patients diagnosed with multiple sclerosis will be recruited from outpatient neurology and physical therapy clinics. Following clinical screening, eligible participants will be randomly assigned into two parallel groups:
The Study Group: Will receive High-Intensity Focused Electromagnetic Therapy sessions targeted at the core/trunk muscles plus a structured balance exercise program for 8 weeks.
The Control Group: Will receive the structured balance exercise program only for 8 weeks.
- Conditions
- Multiple Sclerosis
- Being tested
- High-Intensity Focused Electromagnetic Therapy, Balance Exercises
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Focused Electromagnetic TherapyDevice
For 8 weeks, two weekly sessions of High-Intensity Focused Electromagnetic Therapy will be used to induce supramaximal contractions to strengthen the central core stabilizers (rectus abdominis, transversus abdominis, and erector spinae)
Balance ExercisesOther
Standardized balance training including static stance variations, dynamic weight-shifting, perturbation training, and functional gait adjustments will be conducted for 30-45 minutes per session through three weekly sessions for a total duration of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Active comparator | Patients with multiple sclerosis who will receive High-Intensity Focused Electromagnetic Therapy targeted at the abdominal and paraspinal core musculature, combined with a specialized balance training program for 8 weeks Receives: Device: High-Intensity Focused Electromagnetic Therapy; Other: Balance Exercises |
| Control group | Active comparator | Patients with multiple sclerosis who will receive the standardized balance training program alone for 8 weeks. Receives: Other: Balance Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Berg Balance Scale will be used to assess balance. A 14-item objective clinical rating scale evaluating functional balance performance (e.g., reaching, turning, standing on one leg). Scores range from 0 to 56, where higher scores indicate better balance control.
Measured: Baseline and after 8 weeks
Secondary outcomes (3)
Health-Related Quality of Life
Multiple Sclerosis Quality of Life-54 Questionnaire will be used to assess quality of life. It is a multidimensional, disease-specific questionnaire combining generic and disease-specific items. It generates 12 subscales along with distinct physical and mental health composite summary scores. Higher scores indicate a better quality of life.
Measured: Baseline and after 8 weeks
Risk of Fall
The Fall Risk Questionnaire will be used to assess the risk of fall. The Fall Risk Questionnaire consists of 12 yes/no questions. For scoring, a "no" answer is scored as zero for all questions, while a "yes" answer is scored as two for the first two questions and as one for the remaining 10 questions. A total Fall Risk Questionnaire score of 4 or higher indicates increased fall risk.
Measured: Baseline and after 8 weeks
Core Muscle Function
The Trunk Impairment Scale will be used to assess core muscle function. It scores static sitting balance, dynamic sitting balance, and trunk coordination. Total scores range from 0 to 23, with higher scores indicating superior core control.
Measured: Baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start22 Jun 2026 (estimated)
- Primary completion8 Oct 2026 (estimated)
- Study completion14 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Middle East University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saher Lotfy El Gayar, Middle East University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646912
- Sponsor's protocol ID
- Electromagnetic Intervention
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-Intensity Focused Electromagnetic Technology on Balance and Quality of Life in Patients With Multiple Sclerosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07646912
- Acronym / sponsor ID
- Electromagnetic Intervention
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Middle East UniversityUniversity, hospital or other
- Study start
- 22 Jun 2026 (estimated)
- Primary completion
- 8 Oct 2026 (estimated)
- Study completion
- 14 Oct 2026 (estimated)
- First posted
- 15 Jun 2026 (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.
Evaluate the effect of High-Intensity Focused Electromagnetic Therapy on dynamic balance, fall risk, core muscle function, and quality of life in patients with multiple sclerosis.
Detailed description
Patients diagnosed with multiple sclerosis will be recruited from outpatient neurology and physical therapy clinics. Following clinical screening, eligible participants will be randomly assigned into two parallel groups:
The Study Group: Will receive High-Intensity Focused Electromagnetic Therapy sessions targeted at the core/trunk muscles plus a structured balance exercise program for 8 weeks.
The Control Group: Will receive the structured balance exercise program only for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Active comparator | Device: High-Intensity Focused Electromagnetic Therapy, Other: Balance ExercisesPatients with multiple sclerosis who will receive High-Intensity Focused Electromagnetic Therapy targeted at the abdominal and paraspinal core musculature, combined with a specialized balance training program for 8 weeks |
| Control group | Active comparator | Other: Balance ExercisesPatients with multiple sclerosis who will receive the standardized balance training program alone for 8 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Confirmed clinical diagnosis of Multiple Sclerosis according to the revised McDonald criteria.
- Expanded Disability Status Scale score range between 3.0 and 5.5.
- Clinically stable condition with no neurological relapses or corticosteroid therapy within the past 3 months.
Key exclusion criteria (5 listed)
- Presence of pacemakers, internal defibrillators, or metallic implants in the torso/abdominal region.
- Severe cognitive impairment interfering with the understanding of instructions or questionnaires.
- Other concomitant neurological or musculoskeletal orthopedic conditions that independently affect balance or gait.
- Severe visual deficits or uncorrected vestibular disorders.
- Pregnancy.
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 |
|---|---|---|
| High-Intensity Focused Electromagnetic TherapyFor 8 weeks, two weekly sessions of High-Intensity Focused Electromagnetic Therapy will be used to induce supramaximal contractions to strengthen the central core stabilizers (rectus abdominis, transversus abdominis, and erector spinae) | Device | Experimental group |
| Balance ExercisesStandardized balance training including static stance variations, dynamic weight-shifting, perturbation training, and functional gait adjustments will be conducted for 30-45 minutes per session through three weekly sessions for a total duration of 8 weeks. | Other | Control group, Experimental group |
Primary outcome
Balance
Time frame: Baseline and after 8 weeks
Berg Balance Scale will be used to assess balance. A 14-item objective clinical rating scale evaluating functional balance performance (e.g., reaching, turning, standing on one leg). Scores range from 0 to 56, where higher scores indicate better balance control.
3 secondary outcomes
Health-Related Quality of Life
Time frame: Baseline and after 8 weeks
Risk of Fall
Time frame: Baseline and after 8 weeks
Core Muscle Function
Time frame: Baseline and after 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- 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.
Mohammed Youssef Elhamrawy, Ph.D contact
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Focused Electromagnetic Therapy and Balance Exercises in people with Multiple Sclerosis, run by Middle East University.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saher Lotfy Elgayar, Ph.D (+201020429911, saherlotfy020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: Baseline and after 8 weeks). 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 15 Jun 2026.