## Protocol Section
### Identification Module
**NCT ID:** NCT06428864

**Acronym:** GSSCAN

**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

**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

#### Organization Study ID Info
**ID:** 69HCL24_0513
#### Organization
**Class:** OTHER
**Full Name:** Hospices Civils de Lyon
### Status Module
#### Completion Date
**Date:** 2023-11-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-10-01

**Type:** ACTUAL

#### Start Date
**Date:** 2023-09-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hospices Civils de Lyon

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Neuromuscular Diseases

- Scoliosis

**Keywords:**

- Scoliosis

- Neuromuscular Diseases

- Orthotic device

- Brace

- Cast

- 3D Scan application

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patient with a Garchois brace produced after a plaster cast

**Intervention Names:**

- Device: Plaster cast

**Label:** Cast

#### Arm Group 2

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

**Intervention Names:**

- Device: 3D Scanning

**Label:** Scan

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cast

**Description:** Wearing a Garchois brace produced after a plaster cast

**Name:** Plaster cast

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Scan

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

**Name:** 3D Scanning

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Mean differences in Cobb angles measured by spinal X-rays before and after wearing the brace for the 2 groups of patients

**Measure:** Assessment of Cobb angles

**Time Frame:** Up to 3 months

### Eligibility Module

**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

**Maximum Age:** 18 Years

**Minimum Age:** 1 Year

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

**Study Population:** Neuromuscular patients from a paediatric rehabilitation center

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bron

**Country:** France

**Facility:** L'Escale - HFME

**Zip:** 69500

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013121

- Term: Spinal Curvatures

- ID: D000013122

- Term: Spinal Diseases

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M15417

- Name: Scoliosis

- Relevance: HIGH

- As Found: Scoliosis

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: HIGH

- As Found: Neuromuscular Diseases

- ID: M15918

- Name: Spinal Curvatures

- Relevance: LOW

- As Found: Unknown

- ID: M15919

- Name: Spinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012600

- Term: Scoliosis

- ID: D000009468

- Term: Neuromuscular Diseases

### Misc Info Module

- Version Holder: 2024-05-31
