A Study to Evaluate a New Semi-rigid Brace, the RESILIENT Brace by Thinks Works, as a Way to Limi… (NCT07574632) | Clinical Trial Compass
RecruitingNot Applicable
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.
United States30 participantsStarted 2026-05-28
Plain-language 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.
Who can participate
Age range
9 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment Success Based on Curve Progression at Skeletal Maturity
Timeframe: From baseline to skeletal maturity (approximately up to 36 months)