Repetitive Transcranial Magnetic Stimulation Boosted Exercise Therapy for Lower Limb Spasticity in Multiple Sclerosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- muscle tone measured by Modified Ashworth Scale (MAS)
研究概览
简要总结
Leg spasticity is common problem encountered with a large proportion of patients suffering with multiple sclerosis (MS) with an increasing severity as the disease progresses. It mostly affects the antigravity muscles that significantly complicates transfer, increases fatigue and makes walking more difficult. Hence, leg spasticity often interferes with patients' mobility and significantly influences their quality of life. A great number of multidisciplinary rehabilitation studies has shown a significant effect of numerous specific functional changes in patients with secondary (SP) and primary progressive (PP) MS but there are no reviews related to spasticity. The positive therapeutic effect of modulating Transcranial Magnetic Stimulation ( TMS) methods on spasticity is shown in only two studies, in patients with relapse remitting clinical form in the remission phase of the disease. The effect of TMS on clinical measures of lower limb spasticity, functional inability and the quality of life in patients with SPMS and PPMS will be examined in this study. The objective to this study are to to explore whether rTMS boosted exercise therapy (ET) treatment can bring more improvement in lower limb spasticity than ET treatment alone in these patients.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed clinical form of SPMS and PPMS (established on the basis of the revised McDonald criteria)
- •EDDS score 2-6.5
- •lower limb spasticity caused by MS
- •18 years ≥age of the patient ≤
排除标准
- •clinical worsening of the disease over the past 30 days,
- •the presence of pregnancy, dementia, alcoholism, history of loss of consciousness, epilepsy, metal objects in the head, pacemakers and other electronic devices in the body at a distance of 20cm from the top of the patients head, serious associate diseases (malignancy, heart disease).
结局指标
主要结局
muscle tone measured by Modified Ashworth Scale (MAS)
时间窗: 3 weeks
次要结局
- impact of leg spasticity on daily activities measured by Multiple Sclerosis Spasticity Scale 88 (MSSS-88)(3 weeks)
- Activities of daily living measured by Barthel Index(3 weeks)
- Quality of life measured by Multiple Sclerosis Quality of Life 54 (MSQoL54).(3 weeks)
- Walking mobility measured by Timed 25 Foot Walk test(3 weeks)
研究者
Konstantinovic Ljubica
professor
University of Belgrade