Effect of a Brace on the Adolescent Idiopathic Scoliosis Breathing

Adolescent Idiopathic Scoliosis Clinical Trial

— CTM biomec  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05749562
• Other study ID #: PO23019*
• Status: Completed
• Start date: February 17, 2023
• Est. completion date: March 19, 2024

Study information

• Verified date: March 2024
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 19, 2024
• Est. primary completion date: August 24, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 16 Years

Eligibility

Inclusion Criteria:

• Adolescent girls aged 12 to 16

• With a right thoracic or thoraco-lumbar curvature (right and left)

• With a Cobb angle between 20 and 40°.

• Treated with a Cheneau-Toulouse-Munster brace for more than 1 month

• With a duration of brace wearing of more than 12/24h

• Affiliated to a social security system

Exclusion Criteria:

• Male gender

• Having a secondary scoliosis (neuromuscular, syndromic, post-traumatic, congenital pathology)

• Having a respiratory pathology prior to the diagnosis of scoliosis

• Have a history of spinal surgery

• Having already benefited from a brace treatment

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

Device:
• Cheneau-Toulouse-Munster brace
Full length, orthogonal anteroposterior and lateral X-rays will be taken with the Cheneau-Toulouse-Munster brace.

Locations

Country	Name	City	State
France	Chu Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Lung Capacity (TLC)	change with and without the brace	1 day
Secondary	Forced expiratory volume in one second	change with and without the brace	1 day