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

NCT06428864 | Completed

• 1 other identifier: 69HCL24_0513
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Diseases; Scoliosis

Keywords

Scoliosis; Neuromuscular Diseases; Orthotic device; Brace; Cast; 3D Scan application

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cast

Patient with a Garchois brace produced after a plaster cast

Device: Plaster cast

Scan

Patient with a Garchois brace produced after assessment of the thoracic volume with the 3D scan

Device: 3D Scanning

Interventions

Plaster cast DEVICE

Wearing a Garchois brace produced after a plaster cast

Cast

3D Scanning DEVICE

Wearing a Garchois brace produced after assessment of the thoracic volume with the 3D scan

Scan

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Neuromuscular patients from a paediatric rehabilitation center

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

L'Escale - HFME

Bron, 69500, France

Location

MeSH Terms

Conditions

Neuromuscular Diseases; Scoliosis

Interventions

Casts, Surgical

Condition Hierarchy (Ancestors)

Nervous System Diseases; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 24, 2024
• Study Start: September 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)