Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT07574632
NCT07574632RecruitingNot Applicable

The RESILIENT Scoliosis Brace System Clinical Trial (RESILIENT)

Thinks Works, PBC1 site in 1 country30 target enrollmentStarted: May 28, 2026Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
30
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
9 Years to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor
Thinks Works, PBC
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Development of a Conservative Care and Bracing Registry (CCBR)Adolescent Idiopathic Scoliosis (AIS)Ealy Onset ScoliosisJuvenile Idiopathic ScoliosisInfantile Idiopathic ScoliosisNeuromuscular Scoliosis
NCT07527611National Scoliosis Center280
Completed
Unknown
A 24-Week Physiotherapy Scoliosis-Specific Exercise (PSSE) Intervention Versus Standard Care for Reducing Cobb Angle and Improving Paraspinal Muscle Function in Adolescents With Idiopathic Scoliosis: A Randomized Controlled Trial
ChiCTR2500112330
Recruiting
Not Applicable
The Effect of Peloidotherapy in Young Adults Undergoing Physical Therapy Scoliosis Specific Exercises (PSSE)
NCT07459400Gaziosmanpasa Research and Education Hospital54
Not yet recruiting
Not Applicable
Lumbar Stabilization Exercises in Sedentary Adults
NCT07447167University of West Attica40
Not yet recruiting
Not Applicable
Effect of Progressive Lumbar Stabilization Training on Autonomic Responses and Quality of Life in individual with Low Back Pain: A Randomized Controlled Trial
CTRI/2025/03/081601Department of Physiotherapy Guru Jambheshwar University of Science and Technology32