Actively Recruiting
Effect of Feedback and Monitoring on Patient Compliance With Spinal Orthoses for Scoliosis Treatment
Led by Columbia University · Updated on 2026-04-03
87
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
P
Pediatric Orthopaedic Society of North America
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new device and smartphone app designed to improve how patient compliance with at-home bracing for adolescent idiopathic scoliosis (AIS) is measured. The study aims to provide continuous, objective data on brace fit by monitoring tension, which may help predict compliance and improve brace effectiveness. It also explores whether giving patients and caregivers direct feedback on brace wear through the app can increase compliance rates. Participants will use a standard scoliosis brace fitted with a compliance-monitoring device that tracks brace wear and strap tension continuously. This device communicates with a mobile app that stores and processes the data, allowing both patients and physicians to monitor brace fit and wear time. The study includes feedback mechanisms to help patients achieve the correct strap tension as recommended by their clinicians. During the study, participants and their caregivers will be introduced to the device and app by their physician or research team member. Researchers will measure outcomes such as wear time compliance, valid hours of brace use, and the rate of curve correction while in the brace over up to one year. This monitoring aims to provide better data on brace use and effectiveness, with safety and adherence tracked throughout the study period.
CONDITIONS
Brief Title
Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
- Sanders skeletal stage 4 or earlier
- Clinician-recommended Rigo bracing
- Patient receiving brace treatment
You will not qualify if you...
- Prior spine surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 year
Participants receive a standard-of-care scoliosis brace fitted with a compliance-monitoring device. They will use the device and companion mobile app to monitor brace wear compliance and strap tension throughout the day.
Visits as needed for brace fitting and monitoring
Trial Site Locations
Total: 1 location
1
Morgan Stanley Children's Hospital of NY Presbyterian/Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
B
Benjamin D. Roye, MD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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