An interventional study of Low-Frequency Electromagnetic Field Therapy (0.5 Hz) and Placebo Electromagnetic Field Therapy in Paraparesis, Gait Disorders, Neurologic and Postural Balance Disorders, sponsored by MTI University. Not yet recruiting at 1 site in Saudi Arabia. Open to participants aged 15 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-01-05.
Sponsored by MTI University · Not applicable, Interventional, and Treatment
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
20 studies on the registry are indexed under Paraparesis; 5 are open to participants now.
This study's planned enrollment of 30 is close to the median of 33 across 16 interventional studies indexed under Paraparesis.
Browse Paraparesis studies →MTI University is the lead sponsor of 58 studies on the registry; 11 are open to participants now.
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Medically and psychologically stable. Conscious and cooperative, able to follow instructions. Able to provide informed consent.
Exclusion Criteria:
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).
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
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)
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
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
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.
Time frame: Baseline (pre-treatment) and at 2 months (post-treatment)
Change in Dynamic Balance as Measured by the Biodex Balance System (BBS)
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.
Time frame: 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 months will be compared between groups
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
Change in Stride Length as Measured by 3D Motion Analysis (Qualisys System)
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.
Time frame: Baseline (pre-treatment) and at 2 months (post-treatment)
Change in Base of Support as Measured by 3D Motion Analysis (Qualisys System)
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.
Time frame: Baseline (pre-treatment) and at 2 months (post-treatment)
Plan to share: Undecided
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