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

Not Applicable

Recruiting

• Conditions: Venous Stasis; Deep Venous Thrombosis
• Interventions: Device: Below knee cast; Device: Orthosis VACOped

• Registration Number: NCT03420664
• Lead Sponsor: Karolinska University Hospital

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.

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 Timeline

• Study First Submitted: 2017-02-09
• Study Start: 2017-02-10
• Study First Submitted QC: 2018-02-01
• Study First Posted: 2018-02-05
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-12-24
• Study Completion: 2025-12-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cast immobilisation	Below knee cast	A below knee cast is applied in order to achieve ankle immobilisation for one hour
Orthosis (VACOped) immobilisation	Orthosis VACOped	A below knee orthosis which allows for ankle movement is applied for one hour.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Lower limb macrocirculation under orthosis mobilisation	1 hour	Duplex ultrasound (blood flow)
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 microcirculation under orthosis mobilisation	1 hour	INVOS (regional tissue mixed saturation)

Trial Locations

Locations (1)

Karolinska university Hospital; 🇸🇪 Stockholm, Sweden