Neuromuscular DiseasesGSSCANNCT06428864
Effect of the Use of a 3D Scanner Application on a Smartphone to Mold Garchois Orthotic Device in Neuromuscular Diseases Patients With Scoliosis
An observational study of Neuromuscular Diseases and Scoliosis, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Neuromuscular Diseases, Scoliosis
- What is being tested?
- Plaster cast and 3D Scanning
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2023to 1 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Neuromuscular patients from a paediatric rehabilitation center
Who may be able to join
- Clinical suspicion or genetically confirmed neuromuscular disease
- Neuromuscular scoliosis, with Garchois brace indication
- Under 18 at the time of the first Garchois brace molding
Who cannot join
- Other neuro-orthopaedic disease such as cerebral palsy
- Other thoracic brace than Garchois
- Any spine surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Plaster cast, 3D Scanning
- Keywords
- Scoliosis, Neuromuscular Diseases, Orthotic device, Brace, Cast, 3D Scan application
- Medical subject headings
- Neuromuscular Diseases, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plaster castDevice
Wearing a Garchois brace produced after a plaster cast
3D ScanningDevice
Wearing a Garchois brace produced after assessment of the thoracic volume with the 3D scan
| Study group | Role | What they receive |
|---|---|---|
| Cast | Patient with a Garchois brace produced after a plaster cast Receives: Device: Plaster cast | |
| Scan | Patient with a Garchois brace produced after assessment of the thoracic volume with the 3D scan Receives: Device: 3D Scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Sep 2023
- Primary completion1 Oct 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428864
- Sponsor's protocol ID
- 69HCL24_0513
- Acronym
- GSSCAN
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06428864
- Acronym / sponsor ID
- GSSCAN / 69HCL24_0513
- Conditions
- Neuromuscular Diseases, Scoliosis
- Keywords
- Scoliosis, Neuromuscular Diseases, Orthotic device, Brace, Cast, 3D Scan application
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cast | – | Device: Plaster castPatient with a Garchois brace produced after a plaster cast |
| Scan | – | Device: 3D ScanningPatient with a Garchois brace produced after assessment of the thoracic volume with the 3D scan |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Neuromuscular patients from a paediatric rehabilitation center
Key inclusion criteria (3 listed)
- Clinical suspicion or genetically confirmed neuromuscular disease
- Neuromuscular scoliosis, with Garchois brace indication
- Under 18 at the time of the first Garchois brace molding
Key exclusion criteria (3 listed)
- Other neuro-orthopaedic disease such as cerebral palsy
- Other thoracic brace than Garchois
- Any spine surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plaster castWearing a Garchois brace produced after a plaster cast | Device | Cast |
| 3D ScanningWearing a Garchois brace produced after assessment of the thoracic volume with the 3D scan | Device | Scan |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Diseases and Scoliosis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Cobb angles (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.