Viewing Study NCT06428864



Ignite Creation Date: 2024-06-16 @ 11:47 AM
Last Modification Date: 2024-10-26 @ 3:30 PM
Study NCT ID: NCT06428864
Status: COMPLETED
Last Update Posted: 2024-05-24
First Post: 2024-05-16

Brief Title: Effect of the Use of a 3D Scanner Application on a Smartphone to Mold Garchois Orthotic Device in Neuromuscular Diseases Patients With Scoliosis
Sponsor: Hospices Civils de Lyon
Organization: Hospices Civils de Lyon

Study Overview

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
Status: COMPLETED
Status Verified Date: 2024-05
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: GSSCAN
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 Heshe 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: None

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