Clinical Trials Directory

Trials / Completed

CompletedNCT05749562

Effect of a Brace on the Adolescent Idiopathic Scoliosis Breathing

Study of the Effect of a Cheneau-Toulouse-Munster Brace in the Treatment of Adolescent Idiopathic Scoliosis on Respiratory Function

Status
Completed
Phase
Study type
Observational
Enrollment
12 (actual)
Sponsor
CHU de Reims · Academic / Other
Sex
Female
Age
12 Years – 16 Years
Healthy volunteers
Not accepted

Summary

This study intends to investigate the effect of bracing on respiratory function in the treatment of adolescent idiopathic scoliosis (AIS). In particular, it will look at the effect of the brace on respiratory function and 3D volume of the thoracic cage. An additional evaluation of the pressure forces of the brace, using a connected t-shirt, will be carried out. The investigators hypothesise that the brace will decrease the respiratory parameters and 3D volume of the thoracic cage, especially during deep breathing.

Detailed description

Scoliosis is a 3D deformity of the spine with curvatures occurring in the three planes of space. The brace is widely used for adolescent idiopathic scoliosis. The Cheneau-Toulouse-Munster (CTM) brace is a rigid brace, classically indicated for thoracic and lumbar curves. However, scoliosis induces structural deformation of the rib cage. This can lead to changes in thoracic volume associated with a respiratory disorder, mainly restrictive. But the effect of bracing on pulmonary function currently remains unclear. Few studies in the literature have looked at the impact of the brace on lung function. In those studies, the findings were based on Pulmonary Function Test (PFT) results only. In the CTM biomec study, the investigators propose to evaluate lung function by PFT associated with biplanar radiography using EOS® system, which allows 3D modelling of the rib cage. An additional evaluation of the pressure forces of the CTM brace, using a connected t-shirt, will be carried out to better understand the biomechanics of the brace. It will allow us to observe the stress surfaces on the thorax during the respiratory cycle and to compare them with the adaptation kinematics of the thoracic cage.

Conditions

Interventions

TypeNameDescription
DEVICECheneau-Toulouse-Munster braceFull length, orthogonal anteroposterior and lateral X-rays will be taken with the Cheneau-Toulouse-Munster brace.

Timeline

Start date
2023-02-17
Primary completion
2023-08-24
Completion
2024-03-19
First posted
2023-03-01
Last updated
2024-03-20

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05749562. Inclusion in this directory is not an endorsement.