Bracing During Infantile Scoliosis: Airways Study

Study Overview
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Brief Summary
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Idiopathic juvenile thoracic scoliosis is a tridimensional deformation of the spine which may impact on the intrathoracic organs. Bracing is one of the oldest treatments of spinal deformities. It relies on the indirect manipulation of spinal curvatures in order to prevent curve progression, which may affect respiratory function. The acoustic reflection method is based on the analysis of the reflection of a single transient planar wave giving the longitudinal cross-sectional area profile of the examined cavity. It is noninvasive and harmless. The EOS™ device allows a double incidence, full body, and low-dose X-ray acquisition with thoracic 3D reconstruction. The aim of the study is to evaluate the impact of bracing on the upper airways patency (by means of the acoustic method), on the breathing pattern (noninvasive respiratory muscles assessment), and on the thoracic penetration index (by means of the EOS™)

Official Title
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Bracing During Infantile Scoliosis: Airways Study by Acoustic Method, EOS™ Acquisition and Noninvasive Respiratory Muscles Assessment

Conditions
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Scoliosis

Intervention / Treatment
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* Device: Acoustic reflection method evaluation
* Radiation: EOS™
* Other: Non invasive respiratory muscle assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children with evolutive juvenile thoracic scoliosis with a Cobb angle ≥ 30° requiring either a Milwaukee or a Cheneaux brace in a stable respiratory state Exclusion Criteria: history of spine surgery

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Milwaukee brace<br>Children with an infantile scoliosis requiring Milwaukee bracing | Device: Acoustic reflection method evaluation<br>* Evaluation of airways by acoustic relection method, with and without the bracing device<br>Radiation: EOS™<br>* Scoliosis and thoracic penetration index evaluation by EOS™ acquisition, with and without the bracing device<br>Other: Non invasive respiratory muscle assessment<br>* Non invasive respiratory muscles assessment, with and without the bracing device.<br>|
| Cheneaux brace<br>Children with an infantile scoliosis requiring Cheaneaux bracing | Device: Acoustic reflection method evaluation<br>* Evaluation of airways by acoustic relection method, with and without the bracing device<br>Radiation: EOS™<br>* Scoliosis and thoracic penetration index evaluation by EOS™ acquisition, with and without the bracing device<br>Other: Non invasive respiratory muscle assessment<br>* Non invasive respiratory muscles assessment, with and without the bracing device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of bracing on airways | The aim of the study is to evaluate the impact of bracing on the upper airways patency (by means of the acoustic method), on the breathing pattern (noninvasive respiratory muscles assessment), and on the thoracic penetration index (by means of the EOS™ system) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infantile scoliosis, bracing, acoustic reflection method, EOS™, noninvasive, upper airways, thoracic penetration index, Idiopathic juvenile evolutive thoracic scoliosis