The RESILIENT Scoliosis Brace System Clinical Trial (RESILIENT)
Thinks Works, PBC
Summary
The goal of this clinical trial is to learn if the RESILIENT Scoliosis Brace System works to treat children with idiopathic scoliosis. It will also learn about the safety, comfort, and usability of the brace. The main questions it aims to answer are: * Can the RESILIENT brace prevent the spinal curve from progressing beyond 35 degrees during growth? * How much does the brace correct the curve when it is first worn (in-brace correction)? * How well do participants follow the prescribed brace wear time and force levels? * How does wearing the brace affect quality of life and daily activities? Researchers will study a single group of participants using the RESILIENT brace and evaluate outcomes over time using standard clinical assessments, including X-rays and patient-reported questionnaires. Participants will: * Be fitted with the RESILIENT brace and instructed on how to use it * Wear the brace daily according to physician recommendations throughout their growth period * Attend clinic visits at approximately 4-6 weeks after starting treatment and then about every 6 months for follow-up evaluations * Undergo standard-of-care spine X-rays to monitor curve progression * Complete questionnaires about their quality of life and experience with the brace * Have brace wear time and applied forces monitored using sensors embedded in the device Participants will be followed from the start of brace treatment until they are done growing and have completed treatment.
Eligibility
- Age range
- 9–16 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of Idiopathic Scoliosis (IS) * Age of 9 - 16 years when brace treatment is prescribed * Primary right apex main thoracic scoliosis curve with an apex of T6 or lower * Cobb angle, as measured on a standing PA spine x-ray, 20 degrees or larger and 30 degrees or less, obtained no more than 6 weeks prior to trial enrollment. * Sanders Skeletal Maturity Score of 1-5 * No prior brace treatment or surgery for scoliosis * Patient \& guardian select the RESILIENT brace for treatment * The guardian must confirm that there is cellular connectivity at the place(s) where th…
Interventions
- DeviceThe RESILIENT scoliosis brace system
The RESILIENT brace is a novel semi-rigid (flexible), concealable, adjustable and modular brace with embedded sensors measuring force and wear time.
Location
- Nemours/Alfred I. duPont Hospital for ChildrenWilmington, Delaware