Effect of Neuromuscular Calf Stimulation and Intermittent Pneumatic Compression on Lower Limb Venous Hemodynamics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- IPC(on) Peak Velocity Change From Baseline
研究概览
简要总结
What is known?
- Disorders of peripheral circulation result in vascular morbidity and mortality
- Augmentation of peripheral circulation has been shown to be of benefit in both venous and arterial disease
- The benefit of intermittent pneumatic compression is clinically well evidenced.
- The use of intermittent pneumatic compression is limited by compliance issues related to sleeve application and external power source.
What new information will this trial contribute?
- This evaluates the haemodynamic effect of a new electrical device for augmentation of peripheral circulation
详细描述
RATIONALE - Enhancement of peripheral circulation has been shown to be of benefit in many vascular disorders, and the clinical effectiveness of intermittent pneumatic compression (IPC) is well established in peripheral vascular disease.
OBJECTIVE - This study aims to compare the haemodynamic efficacy of a novel neuromuscular electrical stimulation (NMES) device with IPC in healthy subjects.
METHODS - 10 healthy volunteers will be randomised into two groups, in an interventional cross-over trial. Baseline measurements of haemodynamic velocity and flow will be taken, then subjects given bilateral therapy with each of the two devices in turn. Laser doppler fluximetry readings will be taken from the hand and foot. Baseline readings will be compared with readings taken after immediate cessation of therapy, and after 10 minutes. Tolerability will be measured using a verbal reported score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1
Half of recruited subjects (n=5)
干预措施: Neuromuscular stimulation, followed by intermittent pneumatic compression (Device)
Group 2
Other half of recruited subjects (n=5)
干预措施: Intermittent pneumatic compression, followed by neuromuscular stimulation (Device)
结局指标
主要结局
IPC(on) Peak Velocity Change From Baseline
时间窗: One day
Ultrasound measurements of peak velocity. This is taken from the left leg superficial femoral vein and artery
次要结局
未报告次要终点