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.

Thinks Works, PBC

Status: Enrolling

Conditions: Idiopathic Scoliosis

Treatments: Device: The RESILIENT scoliosis brace system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07574632

RESILIENT2026

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 9 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

RESILIENT Scoliosis Brace System

Experimental group

Description:

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

Treatment:

Device: The RESILIENT scoliosis brace system