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

Sponsor

Karolinska University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03420664

Collaborator

(none)

Enrollment

Location

Arms

82.4

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Venous Stasis Deep Venous Thrombosis	Device: Orthosis VACOped Device: Below knee cast	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Feb 10, 2017

Anticipated Primary Completion Date :

Dec 24, 2022

Anticipated Study Completion Date :

Dec 24, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cast immobilisation A below knee cast is applied in order to achieve ankle immobilisation for one hour	Device: Below knee cast Below knee cast for lower limb immobilisation Other Names: Plastrer cast of Paris
Experimental: Orthosis (VACOped) immobilisation A below knee orthosis which allows for ankle movement is applied for one hour.	Device: Orthosis VACOped Orthosis for lower limb immobilisation

Arm

Intervention/Treatment

Experimental: Cast immobilisation

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

Device: Below knee cast

Below knee cast for lower limb immobilisation

Other Names:

Plastrer cast of Paris

Experimental: Orthosis (VACOped) immobilisation

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

Device: Orthosis VACOped

Orthosis for lower limb immobilisation

Outcome Measures

Primary Outcome Measures

The difference of the effect on the lower limb circulation between cast and VACOped immobilisation [2.5 hours]
Duplex ultrasound (blood flow) and INVOS (regional tissue mixed saturation)

Secondary Outcome Measures

Lower limb macrocirculation under cast immobilisation [1 hour]
Duplex ultrasound (blood flow)
Lower limb microcirculation under cast immobilisation [1 hour]
INVOS (regional tissue mixed saturation)
Lower limb macrocirculation under orthosis mobilisation [1 hour]
Duplex ultrasound (blood flow)
Lower limb microcirculation under orthosis mobilisation [1 hour]
INVOS (regional tissue mixed saturation)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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