RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06785207

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Have a diagnosis of juvenile idiopathic scoliosis or adolescent idiopathic scoliosis
  2. 2. Have a Cobb angle between 20-40 degrees
  3. 3. Are between ages 8-18
  4. 4. Present as Risser 2+ on x-ray
  5. 5. Currently wear a traditionally fabricated scoliosis brace
  6. 6. Have good brace adherence in current brace (self-reported to be 75% of prescribed time)
  7. 7. Be an established patient of Align Clinic and Dr. Timothy Borden
  8. 8. Speak English (survey and semi-structured interview will only be available in English)
  9. 9. Assent and receive parental consent
  1. 1. Have a diagnosis other than juvenile idiopathic scoliosis or adolescent idiopathic scoliosis
  2. 2. Have a Cobb angle outside the range of 20-40 degrees
  3. 3. Present as Risser 0 or 1
  4. 4. Do not currently wear a traditionally fabricated scoliosis brace
  5. 5. Have poor adherence in their current brace
  6. 6. Do not speak English
  7. 7. Are not willing participate in the study

Contacts and Locations

Study Contact

Megan EG Castille, MS
CONTACT
713-798-3098
megan.glahn@bcm.edu

Study Locations (Sites)

University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States
Align Clinic
The Woodlands, Texas, 77380
United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2025-04-01
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • 3D-printed scoliosis brace
  • scoliosis brace
  • scoliosis bracing
  • 3D-printing

Additional Relevant MeSH Terms

  • Scoliosis Idiopathic Adolescent Treatment