Smart brace could keep Kids' spines straight without surgery
NCT ID NCT07574632
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new type of scoliosis brace called RESILIENT, which is flexible, adjustable, and has built-in sensors to track how long and how tightly it's worn. Researchers want to see if it can stop spinal curves from getting worse in 30 children aged 9-16 with mild to moderate scoliosis. Participants will wear the brace daily during their growth years and be followed with X-rays and questionnaires to check the curve and their quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RESILIENT scoliosis brace system (a semi-rigid, adjustable brace with sensors)
- What this could lead to
- If successful, this brace could offer a more comfortable and effective way to prevent scoliosis curves from worsening during growth, reducing the need for surgery.
- What could go wrong
- This is a small, early-stage trial with only 30 participants and no comparison group. The brace may not prevent curve progression for all children, and long-term results are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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9 to 16 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Nemours/Alfred I. duPont Hospital for Children
RECRUITINGWilmington, Delaware, 19803, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A smarter brace for scoliosis: does 3D design stop curves from worsening?
- Can a Night-Time brace or targeted exercises halt scoliosis curves in teens?
- Could simple exercises replace braces for mild scoliosis?
- Your DNA may hold the key to personalized pain relief
- Which Anti-Nausea drug wins for scoliosis surgery? a Head-to-Head test
- Standing within hours of spine surgery: a new test for teen recovery