NCT02265042已完成不适用
Effect of Electrostimulation on Denervated Muscles in Individuals With Spinal Cord Injury
Swiss Paraplegic Research, Nottwil2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- change in muscle volume
研究概览
简要总结
The aim of the study is to investigate whether there is an effect of electrical stimulation on the denervated gluteus muscle (buttocks) in individuals with chronic spinal cord injury. The expected outcome is an increase in muscle volume and a better pressure distribution during sitting. The stimulation of the gluteus muscle is performed daily for 35 minutes over a period of six months. The muscle volume and the pressure distribution are measured before stimulation, three months after having started stimulation and after six months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •chronic spinal cord injury (min. 2 years after injury)
- •lesion height from T10-L5
- •ASIA (American Spinal Cord Injury Association) Impairment Scale A
排除标准
- •acute pressure sore in stimulated area (M. gluteus)
- •arteriosclerosis
- •skin irritation or infection in stimulated area (M. gluteus)
- •< 3 months after plastic surgery in stimulated area (M. gluteus)
结局指标
主要结局
change in muscle volume
时间窗: day 0 to 3 months
determination of muscle volume using magnetic resonance images
次要结局
- change in muscle volume(3 months to 6 months)
- change in sitting pressure(3 months to 6 months)
- change in quality of life(3 months to 6 months)
研究者
Bersch-Porada Ines
PhD in Medical Sciences
Swiss Paraplegic Research, Nottwil
研究点 (2)
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