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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. (RESILIENT)

2026年5月28日 更新者：Thinks Works, PBC

The RESILIENT Scoliosis Brace System Clinical Trial (RESILIENT)

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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

30

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Avery Patient Experience Liaison, Thinks Works
  • 電話番号：844-542-7374
  • メール：hello@thinksworks.com

研究連絡先のバックアップ

研究場所

  • アメリカ
    • Delaware
      • Wilmington、Delaware、アメリカ、19803
        • 募集
        • Nemours/Alfred I. duPont Hospital for Children
        • コンタクト：
          • Petya Yorgova Clinical Research Coordinator Sr, Department of Orthopedics
          • 電話番号：302-651-5920
          • メール：Petya.Yorgova@nemours.org

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
デバイス：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.
他の名前：
  • The RESILIENT brace

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Treatment Success Based on Curve Progression at Skeletal Maturity
時間枠：From baseline to skeletal maturity (approximately up to 36 months)

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)

二次結果の測定

結果測定
メジャーの説明
時間枠
In-Brace Curve Correction at Initial Follow-up
時間枠：4 to 6 weeks
Percent reduction in the primary right main thoracic Cobb angle on standing in-brace posteroanterior spine radiographs obtained at the 4- to 6-week follow-up visit, compared with baseline standing radiographs obtained prior to brace treatment.
4 to 6 weeks
Measurement of brace use compliance as a percentage of prescribed use.
時間枠：From brace initiation through completion of treatment, approximately up to 36 months
Percent compliance with prescribed daily brace wear time and prescribed apex strap force, as measured by force sensors integrated into the brace and recorded in the monitoring system.
From brace initiation through completion of treatment, approximately up to 36 months
Change in Curve Magnitude Following Completion of Brace Treatment
時間枠：From baseline to 4 to 6 months after brace discontinuation
Percent change in the primary right main thoracic Cobb angle from baseline to the final follow-up radiograph obtained after brace discontinuation.
From baseline to 4 to 6 months after brace discontinuation
PROMIS Pediatric Quality of Life Scores
時間枠：Baseline and longitudinal follow-up visits throughout the study, approximately up to 36 months
Patient-reported outcomes measured using PROMIS pediatric modules. Theses are rated using a numeric rating scale. Physical function-mobility is scored 1-4 with 4 being the best outcome score. Peer relationships is scored 1-5 with 5 being the best outcome score. Depressive symptoms is scored 1-5 with 1 being the best outcome score.
Baseline and longitudinal follow-up visits throughout the study, approximately up to 36 months
Scoliosis Research Society-22 (SRS-22) Score
時間枠：Baseline and longitudinal follow-up visits throughout the study, approximately up to 36 months
Patient-reported scoliosis-related quality of life measured using the SRS-22 questionnaire.
Baseline and longitudinal follow-up visits throughout the study, approximately up to 36 months
Patient and Parent Clinical Trial Completion Exit Survey
時間枠：This survey will be given to patients at the completion of their participation in the study, approximately 24 months.
When the patient has completed the clinical trial the patient and parent(s)/guardians will be given a survey to assess their overall experience with the brace treatment. It has questions with numerical rating scores from 1-5 with 1 being the best outcome score and questions with descriptive ratings from very positive-very negative, strongly agree-strongly disagree, very likely-very unlikely, extremely willing-not willing.
This survey will be given to patients at the completion of their participation in the study, approximately 24 months.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Thinks Works, PBC

協力者

Setting Scoliosis Straight Foundation
Nemours Children's Hospital

捜査官

  • 主任研究者：Suken A. Shah, MD、Nemours Hospital for Children

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年5月28日

一次修了 (推定)

2029年5月1日

研究の完了 (推定)

2029年8月1日

試験登録日

最初に提出

2026年4月23日

QC基準を満たした最初の提出物

2026年5月4日

最初の投稿 (実際)

2026年5月8日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月1日

QC基準を満たした最後の更新が送信されました

2026年5月28日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • RESILIENT2026

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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