A review on different methods of scoliosis brace fabrication.
Parvathi Nathan, Siaw Meng Chou, Gabriel Liu
https://pubmed.ncbi.nlm.nih.gov/36723398Actively Recruiting
Phase Not Applicable
Age: 8Years - 18Years
All Genders
ID06785207
Rethinking Rigidity: Development of a 3D-Printed Scoliosis Brace With Varying Flexibility
Led by Baylor College of Medicine · Updated on 2026-06-02
5
Participants Needed
2
Research Sites
N/A
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
Researchers are studying adolescents with idiopathic scoliosis to evaluate a new 3D-printed scoliosis brace designed with varying flexibility. The goal is to improve how comfortable patients feel while wearing the brace, which may help them wear it more consistently. The study focuses on participants who currently use traditional scoliosis braces and aims to collect detailed feedback on the new 3D-printed design. Participants will receive a 3D-printed brace made to match the exact shape of their current brace. Unlike traditional methods that involve carving foam and molding plastic, this brace will be directly 3D printed using a specialized printer and material. Once fabricated, participants will be fitted with the new brace by a scoliosis bracing specialist, ensuring proper adjustment and comfort. They will then perform a series of daily activities while wearing the brace to test comfort and fit. The study involves several steps over 2 to 6 weeks. After enrollment, the 3D brace fabrication takes 1 to 4 weeks. Participants will visit the clinic for brace fitting and activity testing in one day, followed by a 1-week home wear period. At the end, they will provide feedback through surveys and interviews before returning the brace. Researchers will measure perceived comfort compared to their current brace and collect qualitative feedback to assess the new design's impact.
CONDITIONS
Brief Title
Rethinking Rigidity: Development of a 3D-Printed Scoliosis Brace With Varying Flexibility
Who Can Participate
Age: 8Years - 18Years
All Genders
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 or higher on x-ray
- Currently wear a traditionally fabricated scoliosis brace
- Have good brace adherence (self-reported at least 75% of prescribed time)
- Be an established patient of Align Clinic and Dr. Timothy Borden
- Speak English (surveys and interview available only in English)
- Provide assent and 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 on x-ray
- Do not currently wear a traditionally fabricated scoliosis brace
- Have poor adherence to their current brace
- Do not speak English
- Are unwilling to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for enrollment, consent, and baseline testing
Device Implementation
Duration - 1 to 4 weeks
Participants' braces are 3D printed using the exact same shape as their current braces. No additional scans or measurements are required from participants during this time.
No participant visits during fabrication
Device Fitting and Testing
Duration - 1 day
Participants come to the clinic to be fit with the 3D printed brace. The fitting includes trimming, adding straps, and adjustments for comfort. On the same day, participants perform a series of activities to test brace comfort and fit.
1 visit (in-person) lasting 1 to 4 hours including fitting and activity testing
Follow-up
Duration - 1 week after fitting
One week after fitting, participants return the brace and provide feedback through a semi-structured interview and survey about their experience with the 3D printed brace.
1 visit (in-person) for follow-up interview and survey lasting 30 to 60 minutes
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
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Research Team
M
Megan EG Castille, MS
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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Published Research Related To This Trial
A Comparative Study for Material Selection in 3D Printing of Scoliosis Back Brace.
Alfredo Ronca, Valentina Abbate, Davide Felice Redaelli...
https://pubmed.ncbi.nlm.nih.gov/36013868