Actively Recruiting

Phase Not Applicable
Age: 8Years - 17Years
FEMALE
ID03292601

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

Age: 8Years - 17Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Prior spine surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

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

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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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