An observational study in Adolescent Idiopathic Scoliosis, sponsored by CHU de Reims. Completed at 1 site in France. Open to female participants aged 12 Years to 16 Years. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by CHU de Reims · Observational
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.
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.
594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.
This study's enrollment of 12 is below the median of 89 across 233 observational studies indexed under Scoliosis.
Browse Scoliosis studies →CHU de Reims is the lead sponsor of 267 studies on the registry; 50 are open to participants now.
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The study will be conducted with patients treated for scoliosis in the Department of Pediatric Surgery, at the American Memorial Hospital, CHU Reims.
Exclusion Criteria:
Patients will be treated with a Cheneau-Toulouse-Munster (CTM) brace, with a wearing time of more than 12 hours/24h, for more than 1 month.
Device: Cheneau-Toulouse-Munster brace
Full length, orthogonal anteroposterior and lateral X-rays will be taken with the Cheneau-Toulouse-Munster brace.
Total Lung Capacity (TLC)
change with and without the brace
Time frame: 1 day
Forced expiratory volume in one second
change with and without the brace
Time frame: 1 day
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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CHU de Reims