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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Venous Stasis; Deep Venous Thrombosis
• Intervention / Treatment: Device: Below knee cast; Device: Orthosis VACOped

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paul W Ackermann, MD, PhD; Phone Number: +46851770000; Email: paul.ackermann@ki.se
• Study Contact Backup: Name: Luigi Belcastro; Email: Luigi.belcastro@sll.se

Study Locations

• Sweden
  • Stockholm, Sweden, 17176
    • Recruiting
    • Karolinska University Hospital
    • Contact: Luigi Belcastro; Phone Number: +46851775678; Email: luigi.belcastro@karolinska.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference of the effect on the lower limb circulation between cast and VACOped immobilisation	Duplex ultrasound (blood flow) and INVOS (regional tissue mixed saturation)	2.5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower limb macrocirculation under cast immobilisation	Duplex ultrasound (blood flow)	1 hour
Lower limb microcirculation under cast immobilisation	INVOS (regional tissue mixed saturation)	1 hour
Lower limb macrocirculation under orthosis mobilisation	Duplex ultrasound (blood flow)	1 hour
Lower limb microcirculation under orthosis mobilisation	INVOS (regional tissue mixed saturation)	1 hour

Collaborators and Investigators

• Sponsor: Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2017
• Primary Completion (Estimated): December 24, 2024
• Study Completion (Estimated): December 24, 2025

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: immobilisation; circulation; venous stasis; orthosis; cast
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Embolism and Thrombosis; Varicose Veins; Thrombosis; Venous Thrombosis; Varicose Ulcer
• Other Study ID Numbers: SW2017-02-IMMOB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Publishing an abstract on Reasearch Gate

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No