NCT02136537终止不适用
Electrical Stimulation in Peripheral Arterial Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Absolute walking distance
研究概览
简要总结
The investigators wish to investigate the effects of neuromuscular stimulation on intermittent claudication.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of stable intermittent claudication (>6 months) with confirmation by medical imaging
- •ABPI<0.9
- •Absolute walking distance <500m
排除标准
- •Pregnancy
- •Cardiac pacemaker
- •Previous lower limb major amputation
研究组 & 干预措施
Best medical therapy
Active Comparator
Claudicants treated according to local protocol - no added treatment
干预措施: Best medical therapy (Other)
Best medical therapy plus NMES
Experimental
In addition to best medical therapy, subjects will receive bilateral neuromuscular stimulation of their legs, 4 hours per day.
干预措施: Bilateral NMES legs (Device)
Best medical therapy plus NMES
Experimental
In addition to best medical therapy, subjects will receive bilateral neuromuscular stimulation of their legs, 4 hours per day.
干预措施: Best medical therapy (Other)
结局指标
主要结局
Absolute walking distance
时间窗: 6 weeks
Treadmill test (2mph, 0% grade increased by 3.5% every 3 minutes to a maximum of 15%
次要结局
- Claudication distance(6 weeks)
研究者
研究点 (1)
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