NCT07646912

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
4mo left

Started Jun 2026

Shorter than P25 for not_applicable multiple-sclerosis

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

June 22, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2026

6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2026

Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 9, 2026

Last Update Submit

June 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and after 8 weeks

Secondary Outcomes (3)

  • Health-Related Quality of Life

    Baseline and after 8 weeks

  • Risk of Fall

    Baseline and after 8 weeks

  • Core Muscle Function

    Baseline and after 8 weeks

Study Arms (2)

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

Device: High-Intensity Focused Electromagnetic TherapyOther: Balance Exercises

Control group

ACTIVE COMPARATOR

Patients with multiple sclerosis who will receive the standardized balance training program alone for 8 weeks.

Other: Balance Exercises

Interventions

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)

Experimental group

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.

Control groupExperimental group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Saher Lotfy Elgayar, Ph.D

CONTACT

Mohammed Youssef Elhamrawy, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Physiotherapy

Study Record Dates

First Submitted

June 9, 2026

First Posted

June 15, 2026

Study Start (Estimated)

June 22, 2026

Primary Completion (Estimated)

October 8, 2026

Study Completion (Estimated)

October 14, 2026

Last Updated

June 15, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share