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 mayo de 2026 actualizado 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
30
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Avery Patient Experience Liaison, Thinks Works
- Número de teléfono: 844-542-7374
- Correo electrónico: hello@thinksworks.com
Copia de seguridad de contactos de estudio
- Nombre: Ryan C. Murdock, MD, MS. CEO of Thinks Works.
- Correo electrónico: info@thinksworks.com
Ubicaciones de estudio
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Delaware
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Wilmington, Delaware, Estados Unidos, 19803
- Reclutamiento
- Nemours/Alfred I. duPont Hospital for Children
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Contacto:
- Petya Yorgova Clinical Research Coordinator Sr, Department of Orthopedics
- Número de teléfono: 302-651-5920
- Correo electrónico: Petya.Yorgova@nemours.org
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Treatment Success Based on Curve Progression at Skeletal Maturity
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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In-Brace Curve Correction at Initial Follow-up
Periodo de tiempo: 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.
Periodo de tiempo: 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.
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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
Periodo de tiempo: 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.
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From baseline to 4 to 6 months after brace discontinuation
|
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PROMIS Pediatric Quality of Life Scores
Periodo de tiempo: 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.
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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
Periodo de tiempo: 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.
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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
Periodo de tiempo: 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.
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This survey will be given to patients at the completion of their participation in the study, approximately 24 months.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Suken A. Shah, MD, Nemours Hospital for Children
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
28 de mayo de 2026
Finalización primaria (Estimado)
1 de mayo de 2029
Finalización del estudio (Estimado)
1 de agosto de 2029
Fechas de registro del estudio
Enviado por primera vez
23 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de mayo de 2026
Publicado por primera vez (Actual)
8 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RESILIENT2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
No
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