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)
28 de maio de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
30
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Avery Patient Experience Liaison, Thinks Works
- Número de telefone: 844-542-7374
- E-mail: hello@thinksworks.com
Estude backup de contato
- Nome: Ryan C. Murdock, MD, MS. CEO of Thinks Works.
- E-mail: info@thinksworks.com
Locais de estudo
-
-
Delaware
-
Wilmington, Delaware, Estados Unidos, 19803
- Recrutamento
- Nemours/Alfred I. duPont Hospital for Children
-
Contato:
- Petya Yorgova Clinical Research Coordinator Sr, Department of Orthopedics
- Número de telefone: 302-651-5920
- E-mail: Petya.Yorgova@nemours.org
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
The RESILIENT brace is a novel semi-rigid (flexible), concealable, adjustable and modular brace with embedded sensors measuring force and wear time.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Treatment Success Based on Curve Progression at Skeletal Maturity
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
In-Brace Curve Correction at Initial Follow-up
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Suken A. Shah, MD, Nemours Hospital for Children
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
28 de maio de 2026
Conclusão Primária (Estimado)
1 de maio de 2029
Conclusão do estudo (Estimado)
1 de agosto de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
23 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de maio de 2026
Primeira postagem (Real)
8 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RESILIENT2026
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Sim
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .