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

Last updated: March 5, 2024
Sponsor: Karolinska University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Venous Thrombosis

Deep Vein Thrombosis

Claudication

Treatment

Below knee cast

Orthosis VACOped

Clinical Study ID

NCT03420664
SW2017-02-IMMOB
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy individuals

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: Below knee cast
Phase:
Study Start date:
February 10, 2017
Estimated Completion Date:
December 24, 2025

Study 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.

Connect with a study center

  • Karolinska university Hospital

    Stockholm, 17176
    Sweden

    Active - Recruiting

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