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

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called The RESILIENT scoliosis brace system for people with idiopathic scoliosis. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Nemours/Alfred I. duPont Hospital for Children

Wilmington, Delaware, United States

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NCT07574632


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