Effect of Electromagnetic Field Therapy on Balance and Gait in Paraparetic Patients (EMT-BG)

MTI University

Status: Not yet enrolling

Conditions: Postural Balance Disorders; Gait Disorders, Neurologic; Paraparesis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07196956

PT. BU. EC. 28

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 15 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Placebo EMT + Physical Therapy

Placebo Comparator group

Description:

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.

Treatment:

Device: Placebo Electromagnetic Field Therapy

Active EMT + Physical Therapy

Experimental group

Description:

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.

Treatment:

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