Effect of Electromagnetic Field Therapy on Balance and Gait in Paraparetic Patients

NCT07196956 | Not Yet Recruiting

• 1 other identifier: PT. BU. EC. 28
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate whether adding electromagnetic field therapy (EMT) to a standard physical therapy program is more effective than physical therapy alone for improving balance and walking ability in paraparetic patients. Thirty patients with paraparesis (weakness in the lower limbs) due to spinal cord lesions between levels T6 and T12 will be randomly assigned to one of two groups. Both groups will receive a 45-minute physical therapy session, three times per week for two months. The physical therapy program will include stretching, strengthening, balance, and gait training exercises. The key difference will be that one group (Group II) will also receive active low-frequency (0.5 Hz) electromagnetic therapy applied to their spine during their sessions, while the other group (Group I) will receive a placebo (inactive) EMT device. Patients will be assessed before and after the 2-month treatment period. The assessments will measure muscle spasticity (using the Modified Ashworth Scale), balance (using the Biodex Balance System), and detailed gait parameters like step length, stride length, and base of support (using a 3D motion analysis system

Conditions

Gait Disorders, Neurologic; Postural Balance Disorders; Paraparesis

Keywords

Electromagnetic Field Therapy; Electromagnetic Stimulation; Physical Therapy Modalities; Spasticity; Rehabilitation; Biodex Balance System; Motion Analysis; Modified Ashworth Scale

Outcome Measures

Primary Outcomes (1)

• Change in Muscle Spasticity as Measured by the Modified Ashworth Scale (MAS)

  Spasticity of the hip adductor and ankle plantar flexor muscles will be assessed using the Modified Ashworth Scale (MAS), a 6-point ordinal scale (0 = no increase in muscle tone to 4 = rigid in flexion or extension). The primary comparison will be the change in MAS score from baseline to 2 months between the active EMT group and the placebo EMT group.

  Baseline (pre-treatment) and at 2 months (post-treatment)

Secondary Outcomes (4)

• Change in Dynamic Balance as Measured by the Biodex Balance System (BBS)

  Baseline (pre-treatment) and at 2 months (post-treatment)

• Change in Step Length as Measured by 3D Motion Analysis (Qualisys System)

  Step length (distance from heel strike of one foot to heel strike of the opposite foot) will be measured during self-paced walking using the Qualisys 3D Motion Analysis System. The average of three trials will be recorded. Change from baseline to 2 month

• Change in Stride Length as Measured by 3D Motion Analysis (Qualisys System)

  Baseline (pre-treatment) and at 2 months (post-treatment)

• Change in Base of Support as Measured by 3D Motion Analysis (Qualisys System)

  Baseline (pre-treatment) and at 2 months (post-treatment)

Study Arms (2)

Placebo EMT + Physical Therapy

PLACEBO COMPARATOR

Participants will receive a placebo (inactive) electromagnetic therapy device applied to the spine, combined with a standardized 45-minute physical therapy program. The physical therapy program includes stretching exercises, strengthening exercises, balance training, and gait training. Treatment will be administered three times per week for 2 months.

Device: Placebo Electromagnetic Field Therapy

Active EMT + Physical Therapy

EXPERIMENTAL

ticipants will receive active low-frequency (0.5 Hz) electromagnetic field therapy applied to the spine, combined with the identical 45-minute physical therapy program (stretching, strengthening, balance, and gait training) as the control group. Treatment will be administered three times per week for 2 months.

Device: Low-Frequency Electromagnetic Field Therapy (0.5 Hz)

Interventions

Placebo Electromagnetic Field Therapy DEVICE

identical-appearing electromagnetic therapy device with no active field output (placebo/sham). Applied for 20 minutes per session to the spinal lesion level (T6-T12) while patient is prone. Followed by 10-minute rest. Administered three times per week for 2 months, in conjunction with the identical standardized 45-minute physical therapy program (stretching, strengthening, balance, and gait training) as the active EMT group.

Also known as: Sham EMT, Inactive EMT

Placebo EMT + Physical Therapy

Low-Frequency Electromagnetic Field Therapy (0.5 Hz) DEVICE

Active electromagnetic field therapy delivered via a PMT Quattro PRO device (Italy, 2002). Settings: 0.5 Hz frequency, 30 mA intensity, applied for 20 minutes per session to the spinal lesion level (T6-T12) while patient is prone. Followed by 10-minute rest. Administered three times per week for 2 months, in conjunction with a standardized 45-minute physical therapy program (stretching, strengthening, balance, and gait training).

Also known as: EMT,, Pulsed Electromagnetic Field Therapy

Active EMT + Physical Therapy

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of paraparesis with spinal cord lesion level between T6 and T12. Age between 25 and 45 years. Muscle spasticity graded as II or III on the Modified Ashworth Scale (MAS) for hip adductors and ankle plantar flexors.
• Medically and psychologically stable. Conscious and cooperative, able to follow instructions. Able to provide informed consent.

You may not qualify if:

• Presence of metal implants or pacemakers (contraindicated for electromagnetic therapy).
• History of seizures or epilepsy. Active malignancy or infection. Severe cognitive or psychiatric impairment that would interfere with participation.
• Use of alcohol or recreational drugs during the study period. Participation in another concurrent physical or electromagnetic therapy trial. Unstable medical condition (e.g., uncontrolled hypertension, cardiovascular disease).

Sponsors & Collaborators

• MTI University: lead

Study Sites (1)

Outpatient Clinic, Department of Physical Therapy, Faculty of Applied Medical Science, Najran University

Najrān, Saudi Arabia

Location

MeSH Terms

Conditions

Paraparesis; Gait Disorders, Neurologic; Muscle Spasticity

Condition Hierarchy (Ancestors)

Paresis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Central Study Contacts

Reda kotb Abdelrazik, Ph.D.

CONTACT

+966 53 247 6201; dr_reda_kotb@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both the active and placebo electromagnetic therapy devices will appear identical to participants and study personnel. The settings on the devices will be controlled by an independent technician not involved in patient care or outcome assessment to ensure blinding of participants, care providers, investigators, and outcomes assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Physical Therapy for musculoskeletal disorders and its surgery, Faculty of Physical Therapy, Benha University

Model Details: Thirty paraparetic patients will be randomly assigned to one of two parallel groups. Group I will receive a placebo electromagnetic therapy device plus a standard physical therapy program. Group II will receive active electromagnetic field therapy plus the identical physical therapy program.

Study Record Dates

• First Submitted: September 20, 2025
• First Posted: September 29, 2025
• Study Start: January 11, 2026
• Primary Completion: February 28, 2026
• Study Completion: March 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2026-01

Locations

SA (1)