NCT07574632 · Thinks Works, PBC
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.
(RESILIENT)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 the patient lives
Exclusion criteria
- 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
Where
- Wilmington, Delaware
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 1, 2026 · Source of record for eligibility and locations