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

NCT ID: NCT06428864

Last Updated: 2024-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2023-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Neuromuscular Diseases Scoliosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cast

Patient with a Garchois brace produced after a plaster cast

Plaster cast

Intervention Type DEVICE

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

3D Scanning

Intervention Type DEVICE

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

Interventions

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Plaster cast

Wearing a Garchois brace produced after a plaster cast

Intervention Type DEVICE

3D Scanning

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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L'Escale - HFME

Bron, , France

Site Status

Countries

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France

Other Identifiers

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69HCL24_0513

Identifier Type: -

Identifier Source: org_study_id

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