Adolescent Idiopathic Scoliosis
Conditions
Keywords
Scoliosis, 3D printing, Finite Element Analysis
Brief summary
The goal of this pilot clinical trial is to validate a 3D printed brace designed automatically for patients with Adolescent Idiopathic Scoliosis. The main question it aims to answer is: which parameters leads to a efficient and comfortable brace. Participants will try the brace for a period of 30 minutes, measurement and feedback will be obtained.
Interventions
DEVICETest Brace
Participants will be fitted with the Test Brace and will wear the brace for 30 minutes.
Sponsors
Modulate Technologies
St. Justine's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pilot study with a single group of 15 patients
Eligibility
Sex/Gender
ALL
Age
10 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Diagnostic of Adolescent Idiopathic Scoliosis * Risser 0-2 * Cobb Angle between 20 and 40 degrees * Prescription for a brace * Able to understand French or English
Exclusion criteria
* Grade II or higher Spondylolisthesis * Neuromuscular disease * Past spinal surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Questionnaire | 30 minutes | Questionnaire given to the participant after the testing period. Data about the experience, impressions about the brace and the comfort will be recorded. |
| Orthotist Adjustment Questionnaire | 30 minutes | Questionnaire given to the orthotist after the testing period. Data about the number of adjustment and his experience working with the brace will be recorded. |
Contacts
Primary ContactHubert Labelle, MD
Backup ContactSoraya Barchi
Outcome results
None listed