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.

Part of paid clinical trials in Wilmington, Delaware.

Sponsor
Thinks Works, PBC
Study ID
NCT07574632
Status
Recruiting
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Conditions

  • Idiopathic Scoliosis

Eligibility Criteria

Sex
ALL
Age
9 Years - 16 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 28, 2026
Status verified
May 2026
Primary completion
May 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Nemours/Alfred I. duPont Hospital for ChildrenWilmingtonDelaware19803
Petya Yorgova Clinical Research Coordinator Sr, Department of Orthopedics
[email protected]
302-651-5920

Find similar trials in Wilmington, DE

By research site
Nemours/Alfred I. duPont Hospital for Children· Wilmington, DE

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