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

NCT ID: NCT07196956

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-11
• Study Completion Date: 2026-03-01

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

Paraparesis; Gait Disorders, Neurologic; Postural Balance Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo EMT + Physical Therapy

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.

Group Type: PLACEBO_COMPARATOR

Placebo Electromagnetic Field Therapy

Intervention Type: 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.

Active EMT + Physical Therapy

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.

Group Type: EXPERIMENTAL

Low-Frequency Electromagnetic Field Therapy (0.5 Hz)

Intervention Type: 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).

Interventions

Low-Frequency Electromagnetic Field Therapy (0.5 Hz)

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).

Intervention Type: DEVICE

Placebo Electromagnetic Field Therapy

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.

Intervention Type: DEVICE

Other Intervention Names

EMT,; Pulsed Electromagnetic Field Therapy; Sham EMT; Inactive EMT

Eligibility Criteria

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).

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MTI University

OTHER

Sponsor Role: lead

Responsible Party

reda abd elrazik

Associate Professor, Department of Physical Therapy for musculoskeletal disorders and its surgery, Faculty of Physical Therapy, Benha University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Najrān, , Saudi Arabia

Countries

Saudi Arabia

Central Contacts

Reda kotb Abdelrazik, Ph.D.

Role: CONTACT

dr_reda_kotb@yahoo.com

+966 53 247 6201

Facility Contacts

reda kotb abdelrazik, phd

Role: primary

dr_reda_kotb@yahoo.com

+966 53476201

Other Identifiers

PT. BU. EC. 28

Identifier Type: -

Identifier Source: org_study_id