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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.

NCT07574632 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-06-01

No results posted yet for this study

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.

Conditions

  • Idiopathic Scoliosis

Interventions

DEVICE

The 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.

Sponsors & Collaborators

  • Setting Scoliosis Straight Foundation

    collaborator OTHER

  • Nemours Children's Hospital

    collaborator OTHER

  • Thinks Works, PBC

    lead INDUSTRY

Principal Investigators

  • Suken A. Shah, MD · Nemours Hospital for Children

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
9 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-28
Primary Completion
2029-05-31
Completion
2029-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07574632 on ClinicalTrials.gov