Effect of Electromagnetic Field Therapy on Balance and Gait in Paraparetic Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-45
SponsorMTI University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Presence of metal implants or pacemakers (contraindicated for electromagnetic therapy).
Trial design
Design model
Parallel
Treatments tested in this trial
Low-Frequency Electromagnetic Field Therapy (0.5 Hz)
DeviceActive 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).
Placebo Electromagnetic Field Therapy
Deviceidentical-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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Placebo EMT + Physical TherapyPlacebo comparator 1 intervention
Group B: Active EMT + Physical TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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 month3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov
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