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

May 22, 2024 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69500
        • L'Escale - HFME

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Neuromuscular patients from a paediatric rehabilitation center

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cast
Patient with a Garchois brace produced after a plaster cast
Device: Plaster cast
Wearing a Garchois brace produced after a plaster cast
Scan
Patient with a Garchois brace produced after assessment of the thoracic volume with the 3D scan
Device: 3D Scanning
Wearing a Garchois brace produced after assessment of the thoracic volume with the 3D scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

May 16, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 24, 2024

Last Update Submitted That Met QC Criteria

May 22, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL24_0513

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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