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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMiddle East University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • High-Intensity Focused Electromagnetic Therapy

    Device

    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 Exercises

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Experimental groupActive comparator 2 interventions
Group B: Control groupActive comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline and after 8 weeks

Secondary outcomes

1

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.

Time frame
Baseline and after 8 weeks
2

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.

Time frame
Baseline and after 8 weeks
3

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.

Time frame
Baseline and after 8 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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