Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05749562
Status:
COMPLETED
Last Update Posted:
2024-03-20
First Post:
2023-02-06
Brief Title:
Effect of a Brace on the Adolescent Idiopathic Scoliosis Breathing
Sponsor:
CHU de Reims
Organization:
CHU de Reims
Study Overview
Official Title:
Study of the Effect of a Cheneau-Toulouse-Munster Brace in the Treatment of Adolescent Idiopathic Scoliosis on Respiratory Function
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CTM biomec
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None