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Clinical Trials/NCT06428864
NCT06428864
Completed
Not Applicable

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

Hospices Civils de Lyon1 site in 1 country40 target enrollmentSeptember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neuromuscular Diseases
Sponsor
Hospices Civils de Lyon
Enrollment
40
Locations
1
Primary Endpoint
Assessment of Cobb angles
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2023
End Date
November 1, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Assessment of Cobb angles

Time Frame: 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

Study Sites (1)

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