NCT04720898已完成不适用
LUNA-EMG to Enhance Lower Limb Motor Functions in Multiple Sclerosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Muscle strength in mV
研究概览
简要总结
The aim of the present study is to evaluate the effects of training performed with the LUNA-EMG system to enhance motor functions of the lower limb in multiple sclerosis. This is a randomized open-label trial. Patients will be randomized into the intervention group (LUNA-EMG, 30-45 minutes once a week for 12 weeks) or in the control group (standard care).
The effect of the training will be measured based on the muscular strength, walking tests, proprioception and a quality of life questionnaire.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •EDSS less or equal to 6.5
- •Between 18 and 70 years old
- •Having signed the informed consent
排除标准
- •Acute pain syndrome
- •Severe cognitive deficits
- •Risk of fracture or unconsolidated fracture
- •Rigid joints (spasticity, severe osteoarthritis and arthritis) or unstable joints
- •Severe ataxia and apraxia
- •Pacemakers and similar implants
- •Insufficient skin conditions
结局指标
主要结局
Muscle strength in mV
时间窗: 12 weeks
Muscular strength is measured with a dynamometer.
次要结局
- Timed Up and Go, seconds(12 weeks)
- Timed 25-Foot Walk, seconds(12 weeks)
- Proprioception(12 weeks)
研究者
研究点 (2)
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