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.

NCT07574632 | Not Yet Recruiting FDA Device

• 1 other identifier: RESILIENT2026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Treatment Success Based on Curve Progression at Skeletal Maturity

  Treatment success is defined as a right main thoracic Cobb angle less than or equal to 35 degrees at skeletal maturity. Treatment failure is defined as progression of the curve to greater than 35 degrees at any time during the treatment period. Cobb angle measurements are obtained from standing posteroanterior spine radiographs and assessed by independent reviewers blinded to patient information. Skeletal maturity is defined as a Sanders Skeletal Maturity Score of ≥7B, absence of longitudinal height increase over the preceding 6 months, and, for female participants, at least 18 months post-menarche.

  From baseline to skeletal maturity (approximately up to 36 months)

Secondary Outcomes (6)

• In-Brace Curve Correction at Initial Follow-up

  4 to 6 weeks

• Measurement of brace use compliance as a percentage of prescribed use.

  From brace initiation through completion of treatment, approximately up to 36 months

• Change in Curve Magnitude Following Completion of Brace Treatment

  From baseline to 4 to 6 months after brace discontinuation

• PROMIS Pediatric Quality of Life Scores

  Baseline and longitudinal follow-up visits throughout the study, approximately up to 36 months

• Scoliosis Research Society-22 (SRS-22) Score

  Baseline and longitudinal follow-up visits throughout the study, approximately up to 36 months

Study Arms (1)

RESILIENT Scoliosis Brace System

EXPERIMENTAL

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

Device: The RESILIENT scoliosis brace system

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.

Also known as: The RESILIENT brace

RESILIENT Scoliosis Brace System

Eligibility Criteria

• Age: 9 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thinks Works, PBC: lead
• Setting Scoliosis Straight Foundation: collaborator
• Nemours Children's Hospital: collaborator

Study Sites (1)

Nemours/Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Suken A. Shah, MD

  Nemours Hospital for Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Avery Patient Experience Liaison, Thinks Works

CONTACT

844-542-7374; hello@thinksworks.com

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

CONTACT

info@thinksworks.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)