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Rethinking Rigidity: Development of a 3D-Printed Scoliosis Brace With Varying Flexibility

RecruitingNAAges 8 Years - 18 YearsAllBaylor College of Medicine
NCT06785207 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 feedba

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📋 Eligibility rules (as published)
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
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What it tests

  • 3D-printed scoliosis brace
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Where

2 sites
University of Texas Health Science Center at Houston
Houston, United States
Align Clinic
The Woodlands, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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