The Effects of Different Types of Ankle Immobilisation in the Micro- and Macrocirculation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The difference of the effect on the lower limb circulation between cast and VACOped immobilisation
研究概览
简要总结
In this study we are going to measure the blood flow in the lower limbs under cast immobilisation and also under mobilisation with an orthosis. The aim is to evaluate how the aforementioned modalities affect the blood flow and also to compare between the two.
详细描述
Background: Lower limb immobilisation, for example after an Achilles tendon rupture, is known to be a cause for DVT, partly due to blood stasis. VACOped is a weight-bearing orthosis with adjustable range of motion of the ankle which is used in our department in patients operated for Achilles tendon rupture.
Aim: To assess the effects of a) lower leg casting in equinus without loading and b) application of the aforementioned orthosis with full weight baring in blood flow and microcirculation in the lower limbs.
Study Plan: Ten healthy individuals are planned to be recruited for this study. Blood flow in the Right popliteal will be measured with vein before, 30 and 60 min after the application of the cast or orthosis (alternate order between consequent individuals) with Duplex Ultrasound. The orthosis will be set to allow for ankle plantarflexion restricted between 15 and 30 degrees. Tissue oxygen saturation in the lower limbs will also be measured using a somatic regional oxymetry modality, INVOS, with adhesive sensors applied on each leg above the soleus.
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
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals
排除标准
- •Severe cardiovascular or renal disease causing pitting oedema
- •Previous operation in the lower limbs affecting the vascular or lymphatic system
- •Pregnancy
研究组 & 干预措施
Cast immobilisation
A below knee cast is applied in order to achieve ankle immobilisation for one hour
干预措施: Below knee cast (Device)
Orthosis (VACOped) immobilisation
A below knee orthosis which allows for ankle movement is applied for one hour.
干预措施: Orthosis VACOped (Device)
结局指标
主要结局
The difference of the effect on the lower limb circulation between cast and VACOped immobilisation
时间窗: 2.5 hours
Duplex ultrasound (blood flow) and INVOS (regional tissue mixed saturation)
次要结局
- Lower limb macrocirculation under orthosis mobilisation(1 hour)
- Lower limb macrocirculation under cast immobilisation(1 hour)
- Lower limb microcirculation under cast immobilisation(1 hour)
- Lower limb microcirculation under orthosis mobilisation(1 hour)
研究者
Paul Ackermann
Primary Investigator
Karolinska University Hospital