NCT03420664

Comparison of the Effects of Lower Limb Immobilisation With Cast and Orthosis

The Effects of Different Types of Ankle Immobilisation in the Micro- and Macrocirculation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Venous Stasis
• Deep Venous Thrombosis

Interventions

Type	Name	Description
DEVICE	Orthosis VACOped	Orthosis for lower limb immobilisation
DEVICE	Below knee cast	Below knee cast for lower limb immobilisation

Timeline

• Start date: 2017-02-10
• Primary completion: 2024-12-24
• Completion: 2025-12-24
• First posted: 2018-02-05
• Last updated: 2024-03-06

Locations

1 site across 1 country: Sweden