Bracing During Infantile Scoliosis: Airways Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01087034

Acronym

MASI

Enrollment

Registered

2010-03-15

Start date

2010-02-28

Completion date

2011-06-30

Last updated

2012-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis

Keywords

Infantile scoliosis, bracing, acoustic reflection method, EOS™, noninvasive, upper airways, thoracic penetration index, Idiopathic juvenile evolutive thoracic scoliosis

Brief 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™)

Interventions

DEVICEAcoustic reflection method evaluation

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

RADIATIONEOS™

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

OTHERNon invasive respiratory muscle assessment

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Impact of bracing on airways	6 months	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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026