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

Официальное название

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

Обзор

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

Вмешательства

• Устройство 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).
• Устройство 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.

Первичные конечные точки

• Change in Muscle Spasticity as Measured by the Modified Ashworth Scale (MAS) [Срок оценки: Baseline (pre-treatment) and at 2 months (post-treatment)]

Вторичные конечные точки (4)

• Change in Dynamic Balance as Measured by the Biodex Balance System (BBS) [Срок оценки: Baseline (pre-treatment) and at 2 months (post-treatment)]
• Change in Step Length as Measured by 3D Motion Analysis (Qualisys System) [Срок оценки: 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) [Срок оценки: Baseline (pre-treatment) and at 2 months (post-treatment)]
• Change in Base of Support as Measured by 3D Motion Analysis (Qualisys System) [Срок оценки: Baseline (pre-treatment) and at 2 months (post-treatment)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Саудовская Аравия · 1 центр

• Outpatient Clinic, Department of Physical Therapy, Faculty of Applied Medical Science, Naj — Najran

Идентификаторы

NCT: NCT07196956 · PT. BU. EC. 28

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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