Gait Disorders, Neurologic, Paraparesis, Postural Balance Disorders
Conditions
Keywords
Electromagnetic Field Therapy, Electromagnetic Stimulation, Physical Therapy Modalities, Spasticity, Rehabilitation, Biodex Balance System, Motion Analysis, Modified Ashworth Scale
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
Interventions
DEVICELow-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).
DEVICEPlacebo 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.
Sponsors
MTI University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Both the active and placebo electromagnetic therapy devices will appear identical to participants and study personnel. The settings on the devices will be controlled by an independent technician not involved in patient care or outcome assessment to ensure blinding of participants, care providers, investigators, and outcomes assessors.
Intervention model description
Thirty paraparetic patients will be randomly assigned to one of two parallel groups. Group I will receive a placebo electromagnetic therapy device plus a standard physical therapy program. Group II will receive active electromagnetic field therapy plus the identical physical therapy program.
Eligibility
Sex/Gender
ALL
Age
15 Years to 45 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Muscle Spasticity as Measured by the Modified Ashworth Scale (MAS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Dynamic Balance as Measured by the Biodex Balance System (BBS) | 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. |
| 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 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 |
| Change in Stride Length as Measured by 3D Motion Analysis (Qualisys System) | 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. |
| Change in Base of Support as Measured by 3D Motion Analysis (Qualisys System) | 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. |
Countries
Saudi Arabia
Contacts
Primary ContactReda kotb Abdelrazik, Ph.D.
Outcome results
None listed