Resilient Scoliosis Brace in kids with idiopathic scoliosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm study tests the RESILIENT scoliosis brace in children aged 9–16 with idiopathic scoliosis. Researchers will monitor whether wearing the brace prevents progression beyond 35 degrees, measures in-brace correction, adherence to prescribed wear and strength, and effects on quality of life. Outcomes will be assessed through standard clinical assessments, including X-rays and patient-reported questionnaires over the growth period. Participants will be fitted with the RESILIENT brace, instructed on use, and expected to wear it daily as advised by their physician. Safety, comfort, and usability data will also be collected to inform real-world use.

Why it matters

Who can join: the full rules

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 it's running

• Nemours/Alfred I. duPont Hospital for Children
  Wilmington, Delaware, United States Recruiting

Study contacts

• Principal investigator: Suken A. Shah, MD — Nemours Hospital for Children
• Study coordinator: Avery Patient Experience Liaison, Thinks Works
• Email: hello@thinksworks.com
• Phone: 844-542-7374

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.