Effect of High-Intensity Focused Electromagnetic Therapy on Balance and Quality of Life in Patients With Multiple Sclerosis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: High-Intensity Focused Electromagnetic Therapy; Other: Balance Exercises

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saher Lotfy Elgayar, Ph.D; Phone Number: +201020429911; Email: saherlotfy020@gmail.com
• Study Contact Backup: Name: Mohammed Youssef Elhamrawy, Ph.D; Phone Number: +201282805567

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Experimental group; 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 Therapy; 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); Other: Balance Exercises; 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.
Active Comparator: Control group; Patients with multiple sclerosis who will receive the standardized balance training program alone for 8 weeks.	Other: Balance Exercises; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline and after 8 weeks

Collaborators and Investigators

• Sponsor: Middle East University

Study record dates

Study Major Dates

• Study Start (Estimated): June 22, 2026
• Primary Completion (Estimated): October 8, 2026
• Study Completion (Estimated): October 14, 2026

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: Electromagnetic Intervention

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No