Actively Recruiting
Rethinking Rigidity: Development of a 3D-Printed Scoliosis Brace With Varying Flexibility
Led by Baylor College of Medicine · Updated on 2025-04-10
5
Participants Needed
2
Research Sites
39 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
S
Scoliosis Research Society (SRS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Rethinking Rigidity: Development of a 3D-Printed Scoliosis Brace With Varying Flexibility
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Completed
2
Align Clinic
The Woodlands, Texas, United States, 77380
Actively Recruiting
Research Team
M
Megan EG Castille, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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