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Bracing During Infantile Scoliosis: Airways Study

NCT01087034 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2012-06-12

No results posted yet for this study

Summary

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™)

Conditions

  • Scoliosis

Interventions

DEVICE

Acoustic reflection method evaluation

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

RADIATION

EOS™

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

OTHER

Non invasive respiratory muscle assessment

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

Sponsors & Collaborators

  • Ecole Nationale Supérieure des Arts et Metiers

    collaborator UNKNOWN

  • Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau

    lead OTHER

Principal Investigators

  • Nicolas LEBOULANGER, MD · Assistance Publique - Hôpitaux de Paris

  • Brigitte FAUROUX, MD, PhD · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-07-31
Completion
2011-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01087034 on ClinicalTrials.gov