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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-10

Study Completion Date

2025-12-24

Brief Summary

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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.

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Detailed Description

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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

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Venous Stasis Deep Venous Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Research subjects receive lower limb immobilisation with cast and with orthosis alternatively, randomised so as subsequent persons begin with different modality.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cast immobilisation

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

Group Type EXPERIMENTAL

Below knee cast

Intervention Type DEVICE

Below knee cast for lower limb immobilisation

Orthosis (VACOped) immobilisation

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

Group Type EXPERIMENTAL

Orthosis VACOped

Intervention Type DEVICE

Orthosis for lower limb immobilisation

Interventions

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Orthosis VACOped

Orthosis for lower limb immobilisation

Intervention Type DEVICE

Below knee cast

Below knee cast for lower limb immobilisation

Intervention Type DEVICE

Other Intervention Names

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Plastrer cast of Paris

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes