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Smart brace could keep Kids' spines straight without surgery

NCT ID NCT07574632

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

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

9 to 16 years

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Nemours/Alfred I. duPont Hospital for Children

    RECRUITING

    Wilmington, Delaware, 19803, United States

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