Effect of a Brace on the Adolescent Idiopathic Scoliosis Breathing

NCT05749562 | Completed

• 1 other identifier: PO23019*
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Adolescent; Female; Biomechanical Phenomena

Outcome Measures

Primary Outcomes (1)

• Total Lung Capacity (TLC)

  change with and without the brace

  1 day

Secondary Outcomes (1)

• Forced expiratory volume in one second

  1 day

Study Arms (1)

Adolescent Idiopathic Scoliosis with right thoracic or thoraco-lumbar curvature

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

Interventions

Cheneau-Toulouse-Munster brace DEVICE

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

Adolescent Idiopathic Scoliosis with right thoracic or thoraco-lumbar curvature

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted with patients treated for scoliosis in the Department of Pediatric Surgery, at the American Memorial Hospital, CHU Reims.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: March 1, 2023
• Study Start: February 17, 2023
• Primary Completion: August 24, 2023
• Study Completion: March 19, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

FR (1)