RESILIENT Brace for Idiopathic Scoliosis
(RESILIENT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Suken A. Shah, MD
Principal Investigator
Nemours Hospital for Children
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are fitted with the RESILIENT brace and instructed on its use. They wear the brace daily according to physician recommendations throughout their growth period.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including spine X-rays and quality of life assessments.
What Are the Treatments Tested in This Trial?
Interventions
- RESILIENT Brace
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients will be fitted with a novel semi-rigid, low-profile, adjustable, and modular scoliosis brace with embedded sensors measuring force and wear time.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Thinks Works, PBC
Lead Sponsor
Nemours Children's Hospital
Collaborator
Setting Scoliosis Straight Foundation
Collaborator
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