The Role of Electromagnetic Field Therapy in Improving Perturbation of Balance and Gait Disorders in Paraparetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Muscle Spasticity as Measured by the Modified Ashworth Scale (MAS)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of paraparesis with spinal cord lesion level between T6 and T
- •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.
排除标准
- •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).
结局指标
主要结局
Change in Muscle Spasticity as Measured by the Modified Ashworth Scale (MAS)
时间窗: 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.
次要结局
- Change in Dynamic Balance as Measured by the Biodex Balance System (BBS)(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 month)
- Change in Base of Support as Measured by 3D Motion Analysis (Qualisys System)(Baseline (pre-treatment) and at 2 months (post-treatment))
- Change in Stride Length as Measured by 3D Motion Analysis (Qualisys System)(Baseline (pre-treatment) and at 2 months (post-treatment))
研究者
reda abd elrazik
Associate Professor, Department of Physical Therapy for musculoskeletal disorders and its surgery, Faculty of Physical Therapy, Benha University
MTI University