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)
2026년 5월 28일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Avery Patient Experience Liaison, Thinks Works
- 전화번호: 844-542-7374
- 이메일: hello@thinksworks.com
연구 연락처 백업
- 이름: Ryan C. Murdock, MD, MS. CEO of Thinks Works.
- 이메일: info@thinksworks.com
연구 장소
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Delaware
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Wilmington, Delaware, 미국, 19803
- 모병
- Nemours/Alfred I. duPont Hospital for Children
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연락하다:
- Petya Yorgova Clinical Research Coordinator Sr, Department of Orthopedics
- 전화번호: 302-651-5920
- 이메일: Petya.Yorgova@nemours.org
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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The RESILIENT brace is a novel semi-rigid (flexible), concealable, adjustable and modular brace with embedded sensors measuring force and wear time.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Treatment Success Based on Curve Progression at Skeletal Maturity
기간: From baseline to skeletal maturity (approximately up to 36 months)
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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)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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In-Brace Curve Correction at Initial Follow-up
기간: 4 to 6 weeks
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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.
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4 to 6 weeks
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Measurement of brace use compliance as a percentage of prescribed use.
기간: From brace initiation through completion of treatment, approximately up to 36 months
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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.
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From brace initiation through completion of treatment, approximately up to 36 months
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Change in Curve Magnitude Following Completion of Brace Treatment
기간: From baseline to 4 to 6 months after brace discontinuation
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Percent change in the primary right main thoracic Cobb angle from baseline to the final follow-up radiograph obtained after brace discontinuation.
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From baseline to 4 to 6 months after brace discontinuation
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PROMIS Pediatric Quality of Life Scores
기간: Baseline and longitudinal follow-up visits throughout the study, approximately up to 36 months
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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.
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Baseline and longitudinal follow-up visits throughout the study, approximately up to 36 months
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Scoliosis Research Society-22 (SRS-22) Score
기간: Baseline and longitudinal follow-up visits throughout the study, approximately up to 36 months
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Patient-reported scoliosis-related quality of life measured using the SRS-22 questionnaire.
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Baseline and longitudinal follow-up visits throughout the study, approximately up to 36 months
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Patient and Parent Clinical Trial Completion Exit Survey
기간: This survey will be given to patients at the completion of their participation in the study, approximately 24 months.
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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.
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This survey will be given to patients at the completion of their participation in the study, approximately 24 months.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Suken A. Shah, MD, Nemours Hospital for Children
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 5월 28일
기본 완료 (추정된)
2029년 5월 1일
연구 완료 (추정된)
2029년 8월 1일
연구 등록 날짜
최초 제출
2026년 4월 23일
QC 기준을 충족하는 최초 제출
2026년 5월 4일
처음 게시됨 (실제)
2026년 5월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 28일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- RESILIENT2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
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아니
미국 FDA 규제 기기 제품 연구
예
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .