NCT06785207 Rethinking Rigidity: Development of a 3D-Printed Scoliosis Brace With Varying Flexibility
| NCT ID | NCT06785207 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baylor College of Medicine |
| Condition | Scoliosis Idiopathic Adolescent Treatment |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5 participants in total. It began in 2025-04-01 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Scoliosis bracing is an effective treatment method for idiopathic scoliosis, but only if worn consistently for many hours a day. Unsurprisingly, brace discomfort is a significant deterrent against treatment adherence. For decades, custom braces for idiopathic scoliosis have been fabricated using one of three materials - copolymer, polypropylene, or polyethylene. The application of the biomechanical principles behind bracing have improved over the years, but the materials have not. The investigators' goal is to expand fabrication options by testing a 3D-printed scoliosis brace with variable flexibility. The aim is to improve patients' perceived brace comfort. After optimizing the brace design, the investigators will collect patient feedback about the design from currently braced participants. These participants understand what a standard brace feels like and will provide impactful feedback.
Eligibility Criteria
Inclusion Criteria: 1. Have a diagnosis of juvenile idiopathic scoliosis or adolescent idiopathic scoliosis 2. Have a Cobb angle between 20-40 degrees 3. Are between ages 8-18 4. Present as Risser 2+ on x-ray 5. Currently wear a traditionally fabricated scoliosis brace 6. Have good brace adherence in current brace (self-reported to be 75% of prescribed time) 7. Be an established patient of Align Clinic and Dr. Timothy Borden 8. Speak English (survey and semi-structured interview will only be available in English) 9. Assent and receive parental consent Exclusion Criteria: 1. Have a diagnosis other than juvenile idiopathic scoliosis or adolescent idiopathic scoliosis 2. Have a Cobb angle outside the range of 20-40 degrees 3. Present as Risser 0 or 1 4. Do not currently wear a traditionally fabricated scoliosis brace 5. Have poor adherence in their current brace 6. Do not speak English 7. Are not willing participate in the study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06785207 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 18 Years, studying Scoliosis Idiopathic Adolescent Treatment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06785207 currently recruiting?
Yes, NCT06785207 is actively recruiting participants. Contact the research team at megan.glahn@bcm.edu for enrollment information.
Where is the NCT06785207 trial being conducted?
This trial is being conducted at Houston, United States, The Woodlands, United States.
Who is sponsoring the NCT06785207 clinical trial?
NCT06785207 is sponsored by Baylor College of Medicine. The trial plans to enroll 5 participants.