RecruitingNot ApplicableNCT07574632

A Study to Evaluate a New Semi-rigid Brace, the RESILIENT Brace by Thinks Works, as a Way to Limit Curve Worsening in Kids With Idiopathic Scoliosis.

The RESILIENT Scoliosis Brace System Clinical Trial (RESILIENT)

Sponsor

Thinks Works, PBC

Enrollment

30 participants

Start Date

May 28, 2026

Study Type

INTERVENTIONAL

Conditions

Idiopathic Scoliosis

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

Min Age: 9 YearsMax Age: 16 Years

Inclusion Criteria8

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 the patient lives

Exclusion Criteria10

Scoliosis other than idiopathic scoliosis: e.g. Neuromuscular, Congenital, or Syndrome Related
Age less than 9 years or older than 16 years
Sanders Skeletal Maturity Score of 6 or greater
Primary Left apex thoracic scoliosis
Primary lumbar scoliosis
Primary Right Thoracic curve with an apex above T6
Inability to remove and apply the brace independently
Inability to respond to written and verbal questions
Patient \& Guardian select traditional TLSO for treatment
Guardian confirms there is no cellular connectivity at the place(s) where the patient lives