Rethinking Rigidity: Development of a 3D-Printed Scoliosis Brace With Varying Flexibility
Recruiting now · Not applicable
Conditions studied: Scoliosis Idiopathic Adolescent Treatment
In brief
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.
Key facts
- Study ID
- NCT06785207
- Run by
- Baylor College of Medicine
- People needed
- 5
- Starts
- 2025-04-01
- Expected to finish
- 2026-10-31
- Last updated by the study team
- 2026-06-02
Who can join
Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Have a diagnosis of juvenile idiopathic scoliosis or adolescent idiopathic scoliosis
- Have a Cobb angle between 20-40 degrees
- Are between ages 8-18
- Present as Risser 2+ on x-ray
- Currently wear a traditionally fabricated scoliosis brace
- Have good brace adherence in current brace (self-reported to be 75% of prescribed time)
- Be an established patient of Align Clinic and Dr. Timothy Borden
- Speak English (survey and semi-structured interview will only be available in English)
- Assent and receive parental consent
You may not qualify if…
- Have a diagnosis other than juvenile idiopathic scoliosis or adolescent idiopathic scoliosis
- Have a Cobb angle outside the range of 20-40 degrees
- Present as Risser 0 or 1
- Do not currently wear a traditionally fabricated scoliosis brace
- Have poor adherence in their current brace
- Do not speak English
- Are not willing participate in the study
Where it is running
- Align Clinic — The Woodlands, Texas, United States (enrolling)
- University of Texas Health Science Center at Houston — Houston, Texas, United States
Full record on ClinicalTrials.gov
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