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

Karolinska University Hospital

Status: Enrolling

Conditions: Deep Venous Thrombosis; Venous Stasis

Treatments: Device: Below knee cast; Device: Orthosis VACOped

Study type: Interventional

Funder types: Other

Identifiers

NCT03420664

SW2017-02-IMMOB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy individuals

Exclusion criteria

• Severe cardiovascular or renal disease causing pitting oedema
• Previous operation in the lower limbs affecting the vascular or lymphatic system
• Pregnancy

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Cast immobilisation

Experimental group

Description:

A below knee cast is applied in order to achieve ankle immobilisation for one hour

Treatment:

Device: Below knee cast

Orthosis (VACOped) immobilisation

Experimental group

Description:

A below knee orthosis which allows for ankle movement is applied for one hour.

Treatment:

Device: Orthosis VACOped