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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)

28. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Avery Patient Experience Liaison, Thinks Works
  • Telefonnummer: 844-542-7374
  • E-post: hello@thinksworks.com

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Delaware
      • Wilmington, Delaware, Forente stater, 19803
        • Rekruttering
        • Nemours/Alfred I. duPont Hospital for Children
        • Ta kontakt med:
          • Petya Yorgova Clinical Research Coordinator Sr, Department of Orthopedics
          • Telefonnummer: 302-651-5920
          • E-post: Petya.Yorgova@nemours.org

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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.
Andre navn:
  • The RESILIENT brace

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Treatment Success Based on Curve Progression at Skeletal Maturity
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
In-Brace Curve Correction at Initial Follow-up
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Thinks Works, PBC

Samarbeidspartnere

Setting Scoliosis Straight Foundation
Nemours Children's Hospital

Etterforskere

  • Hovedetterforsker: Suken A. Shah, MD, Nemours Hospital for Children

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. mai 2026

Primær fullføring (Antatt)

1. mai 2029

Studiet fullført (Antatt)

1. august 2029

Datoer for studieregistrering

Først innsendt

23. april 2026

Først innsendt som oppfylte QC-kriteriene

4. mai 2026

Først lagt ut (Faktiske)

8. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RESILIENT2026

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

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