Recruiting

RESILIENT Brace

Sponsor:

Thinks Works, PBC

Code:

NCT07574632

Conditions

Idiopathic Scoliosis

Eligibility Criteria

Sex: All

Age: 9 - 16

Healthy Volunteers: Not accepted

Interventions

The RESILIENT scoliosis brace system

Study Details

Brief 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.

Conditions

Idiopathic Scoliosis

Study ID

NCT07574632

Start date

May 28, 2026

Status verified date

May, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

May, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 16

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RESILIENT Scoliosis Brace System

Patients will be fitted with a novel semi-rigid, low-profile, adjustable, and modular scoliosis brace with embedded sensors measuring force and wear time.

Interventions

The RESILIENT scoliosis brace system

The RESILIENT brace is a novel semi-rigid (flexible), concealable, adjustable and modular brace with embedded sensors measuring force and wear time.

Primary outcome measure

  • Treatment Success Based on Curve Progression at Skeletal Maturity [ Time Frame: From baseline to skeletal maturity (approximately up to 36 months) ]

Central Contacts and Locations

Central contacts

Avery Patient Experience Liaison, Thinks Works

844-542-7374hello@thinksworks.com

Ryan C. Murdock, MD, MS. CEO of Thinks Works.

info@thinksworks.com

Locations

Nemours/Alfred I. duPont Hospital for Children

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

Petya Yorgova Clinical Research Coordinator Sr, Department of Orthopedics

302-651-5920Petya.Yorgova@nemours.org

More Information

Sponsor

Thinks Works, PBC

Last update posted

Jun 1, 2026

Last verified

May, 2026

Keywords

  • scoliosis
  • brace
  • idiopathic scoliosis
  • flexible brace
  • semi-rigid brace
  • adolescent idiopathic scoliosis
  • AIS
  • IS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Thinks Works, PBC on 2026-06-01.