Pilot Project on the Automatic Design and 3D Printing of Adolescent Idiopathic Scoliosis Braces (Phase 1)
Not Applicable
Not yet recruiting
- Conditions
- Adolescent Idiopathic Scoliosis
- Interventions
- Device: Test Brace
- Registration Number
- NCT06217510
- Lead Sponsor
- St. Justine's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 15
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Test Brace Test Brace A 3D printed brace designed automatically from a digital twin of the participant.
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method