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

Scoliosis Clinical Trial

— GSSCAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06428864
• Other study ID #: 69HCL24_0513
• Status: Completed
• Start date: September 1, 2023
• Est. completion date: November 1, 2023

Study information

• Verified date: May 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Exclusion Criteria:

• Other neuro-orthopaedic disease such as cerebral palsy

• Other thoracic brace than Garchois

• Any spine surgery

Related Conditions & MeSH terms

• Neuromuscular Diseases
• Scoliosis

Intervention

Device:
• Plaster cast
Wearing a Garchois brace produced after a plaster cast
• 3D Scanning
Wearing a Garchois brace produced after assessment of the thoracic volume with the 3D scan

Locations

Country	Name	City	State
France	L'Escale - HFME	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Cobb angles	Mean differences in Cobb angles measured by spinal X-rays before and after wearing the brace for the 2 groups of patients	Up to 3 months