Bracing During Infantile Scoliosis: Airways Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-06-30

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™)

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Detailed Description

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Conditions

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Scoliosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Milwaukee brace

Children with an infantile scoliosis requiring Milwaukee bracing

Acoustic reflection method evaluation

Intervention Type DEVICE

Evaluation of airways by acoustic relection method, with and without the bracing device

EOS™

Intervention Type RADIATION

Scoliosis and thoracic penetration index evaluation by EOS™ acquisition, with and without the bracing device

Non invasive respiratory muscle assessment

Intervention Type OTHER

Non invasive respiratory muscles assessment, with and without the bracing device.

Cheneaux brace

Children with an infantile scoliosis requiring Cheaneaux bracing

Acoustic reflection method evaluation

Intervention Type DEVICE

Evaluation of airways by acoustic relection method, with and without the bracing device

EOS™

Intervention Type RADIATION

Scoliosis and thoracic penetration index evaluation by EOS™ acquisition, with and without the bracing device

Non invasive respiratory muscle assessment

Intervention Type OTHER

Non invasive respiratory muscles assessment, with and without the bracing device.

Interventions

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Acoustic reflection method evaluation

Evaluation of airways by acoustic relection method, with and without the bracing device

Intervention Type DEVICE

EOS™

Scoliosis and thoracic penetration index evaluation by EOS™ acquisition, with and without the bracing device

Intervention Type RADIATION

Non invasive respiratory muscle assessment

Non invasive respiratory muscles assessment, with and without the bracing device.

Intervention Type OTHER

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