Effect of the Use of a 3D Scanner Application on a Smartphone to Mold Garchois Orthotic Device in Neuromuscular Diseases Patients With Scoliosis

Completed

• Conditions: Scoliosis; Neuromuscular Diseases
• Interventions: Device: Plaster cast; Device: 3D Scanning

• Registration Number: NCT06428864
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Neuromuscular scoliosis is the consequence of general hypotonia involved in certain neuromuscular diseases. Thoracic braces are necessary to slow down the deformation. In France, Garchois brace is largely used in this context because of a better pulmonary tolerance.

Historically, molding of thoracic orthotic brace was based on a plaster cast directly on the patient. He/she is suspended in a frame or is lying on an examining table, and is held by 4 therapists (a physician, an orthoprosthesist, a nurse and a doctor). The position during molding could be very uncomfortable and anxious.

With the development of new technologies, a 3D scan application on smartphone to obtain the volume and deformations of the patient was developed. This tool enables digital acquisition of trunk and head volume while bypassing the seated patient. No plaster strips are used. The resulting negative is digitally filled to obtain a positive. The positive is then corrected before the corset is made, either digitally or after 3D scanning, in plaster or foam. This application was first used in our department in 2017.

The aim of this retrospective monocentric study is to show that this application can be used to produce brace that are as corrective and reliable as braces made after plaster casting, while improving the satisfaction of children, their families and professionals during impression taking. as their parents and of the professionals present during the molding.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Primary Completion: 2023-10-01
• Study Completion: 2023-11-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-22
• Last Update Submitted: 2024-05-22
• Study First Posted: 2024-05-24
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Clinical suspicion or genetically confirmed neuromuscular disease
• Neuromuscular scoliosis, with Garchois brace indication
• Under 18 at the time of the first Garchois brace molding

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Exclusion Criteria

• Other neuro-orthopaedic disease such as cerebral palsy
• Other thoracic brace than Garchois
• Any spine surgery

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cast	Plaster cast	Patient with a Garchois brace produced after a plaster cast
Scan	3D Scanning	Patient with a Garchois brace produced after assessment of the thoracic volume with the 3D scan

Primary Outcome Measures

Name	Time	Method
Assessment of Cobb angles	Up to 3 months	Mean differences in Cobb angles measured by spinal X-rays before and after wearing the brace for the 2 groups of patients

Trial Locations

Locations (1)

L'Escale - HFME; 🇫🇷 Bron, France