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NCT Number: NCT07196956

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

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

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Key information

Conditions

Paraparesis Gait Disorders, Neurologic Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Paresis Pathological Conditions, Signs and Symptoms Postural Balance Disorders Signs and Symptoms

Age range

15 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Najran, Saudi Arabia

Location contact

reda kotb abdelrazik, phd

CONTACT

[email protected]

+966 53476201

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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).

Other names: EMT,, Pulsed Electromagnetic Field Therapy

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.

Other names: Sham EMT, Inactive EMT

Primary outcomes

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

    Time frame: Baseline (pre-treatment) and at 2 months (post-treatment)

    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.

Secondary outcomes

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

    Time frame: Baseline (pre-treatment) and at 2 months (post-treatment)

    Dynamic postural stability will be assessed using the Biodex Balance System. Participants will perform a single-leg stance test (on the non-dominant leg, eyes closed, hands on hips). The system provides a numerical stability index; a lower score indicates better balance. Change from baseline to 2 months will be compared between groups.

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

    Time frame: 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

    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 months will be compared between groups

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

    Time frame: Baseline (pre-treatment) and at 2 months (post-treatment)

    Stride length (distance from heel strike of one foot to the next heel strike of the same 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 months will be compared between groups.

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

    Time frame: Baseline (pre-treatment) and at 2 months (post-treatment)

    Base of support (lateral distance between the left and right feet during walking) 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 months will be compared between groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Reda kotb Abdelrazik, Ph.D.

CONTACT

[email protected]

+966 53 247 6201

Sponsors and collaborators

Lead sponsor

MTI University

Other

Registry information

Official study title

The Role of Electromagnetic Field Therapy in Improving Perturbation of Balance and Gait Disorders in Paraparetic Patients

Acronym: EMT-BG

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 29, 2025
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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