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.

Официальное название

The RESILIENT Scoliosis Brace System Clinical Trial (RESILIENT)

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

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

Вторичные конечные точки (6)

• In-Brace Curve Correction at Initial Follow-up [Срок оценки: 4 to 6 weeks]
• Measurement of brace use compliance as a percentage of prescribed use. [Срок оценки: From brace initiation through completion of treatment, approximately up to 36 months]
• Change in Curve Magnitude Following Completion of Brace Treatment [Срок оценки: From baseline to 4 to 6 months after brace discontinuation]
• PROMIS Pediatric Quality of Life Scores [Срок оценки: Baseline and longitudinal follow-up visits throughout the study, approximately up to 36 months]
• Scoliosis Research Society-22 (SRS-22) Score [Срок оценки: Baseline and longitudinal follow-up visits throughout the study, approximately up to 36 months]
• Patient and Parent Clinical Trial Completion Exit Survey [Срок оценки: This survey will be given to patients at the completion of their participation in the study, approximately 24 months.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Nemours/Alfred I. duPont Hospital for Children — Wilmington

Идентификаторы

NCT: NCT07574632 · RESILIENT2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗