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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. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Delaware
      • Wilmington, Delaware, Forenede Stater, 19803
        • Rekruttering
        • Nemours/Alfred I. duPont Hospital for Children
        • Kontakt:
          • Petya Yorgova Clinical Research Coordinator Sr, Department of Orthopedics
          • Telefonnummer: 302-651-5920
          • E-mail: Petya.Yorgova@nemours.org

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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 navne:
  • The RESILIENT brace

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Thinks Works, PBC

Samarbejdspartnere

Setting Scoliosis Straight Foundation
Nemours Children's Hospital

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. maj 2026

Primær færdiggørelse (Anslået)

1. maj 2029

Studieafslutning (Anslået)

1. august 2029

Datoer for studieregistrering

Først indsendt

23. april 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

8. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RESILIENT2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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