NCT02080039终止不适用
Clinical Pilot Study of the Effect of Electrical Stimulation of Denervated Muscles After Spinal Cord Injury
Swiss Paraplegic Research, Nottwil2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2012年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Magnetic Resonance Imaging to determine the thickness of the gluteal muscle and fat tissue of the buttock.
研究概览
简要总结
In this study the following hypotheses will be tested:
Electrical stimulation of the gluteal muscle (buttocks) leads to
- an increase in the thickness of the gluteal muscle
- a decrease in the thickness of the fat of the buttock area
- a change in the distribution of the middle and maximal seating pressure to a more consistent pressure
- an increase in well-being of the patients.
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
- •Duration of palsy: minimum two years after traumatic or non-traumatic spinal cord injury
- •Level of lesion: T 10 to L 5, AIS A, classified by the American Spinal Injury Association (AISA)
排除标准
- •Acute decubitus in the stimulated area
- •Arteriosclerosis
- •Less than three months after flap surgery or after decubitus in the stimulated area
- •Infections or skin eczema in the stimulated area
结局指标
主要结局
Magnetic Resonance Imaging to determine the thickness of the gluteal muscle and fat tissue of the buttock.
时间窗: 45 min.
次要结局
- Measuring of the seating pressure to determine the distribution of the middle and maximal seating pressure(15 min.)
- Questionnaire on subjective wellbeing(10 min.)
研究者
研究点 (2)
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