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

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ClinicalTrials.gov Identifier: NCT03420664
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : September 21, 2021
Sponsor:
Information provided by (Responsible Party):
Paul Ackermann, Karolinska University Hospital

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : February 10, 2017
Estimated Primary Completion Date : December 24, 2022
Estimated Study Completion Date : December 24, 2023
Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  1. The difference of the effect on the lower limb circulation between cast and VACOped immobilisation [ Time Frame: 2.5 hours ]
    Duplex ultrasound (blood flow) and INVOS (regional tissue mixed saturation)


Secondary Outcome Measures :
  1. Lower limb macrocirculation under cast immobilisation [ Time Frame: 1 hour ]
    Duplex ultrasound (blood flow)

  2. Lower limb microcirculation under cast immobilisation [ Time Frame: 1 hour ]
    INVOS (regional tissue mixed saturation)

  3. Lower limb macrocirculation under orthosis mobilisation [ Time Frame: 1 hour ]
    Duplex ultrasound (blood flow)

  4. Lower limb microcirculation under orthosis mobilisation [ Time Frame: 1 hour ]
    INVOS (regional tissue mixed saturation)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420664


Contacts
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Contact: Paul W Ackermann, MD, PhD +46851770000 paul.ackermann@ki.se
Contact: Luigi Belcastro Luigi.belcastro@sll.se

Locations
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Sweden
Karolinska university Hospital Recruiting
Stockholm, Sweden, 17176
Contact: Luigi Belcastro    +46851775678    luigi.belcastro@karolinska.se   
Sponsors and Collaborators
Karolinska University Hospital
More Information
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Responsible Party: Paul Ackermann, Primary Investigator, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT03420664    
Other Study ID Numbers: SW2017-02-IMMOB
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publishing an abstract on Reasearch Gate

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paul Ackermann, Karolinska University Hospital:
cast
orthosis
immobilisation
venous stasis
circulation
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Varicose Ulcer
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Varicose Veins
Leg Ulcer
Skin Ulcer
Skin Diseases