Clinical trial Recruiting at 1 site Interventional Ages 8 to 17 Women only

Monitoring brace use for adolescents with scoliosis

Official title: Effect of Feedback and Monitoring on Patient Compliance With Spinal Orthoses for Scoliosis Treatment

Run by Columbia University · NCT03292601 · Data updated 2026-11-12

This study is testing a new device and app to help teenagers with scoliosis wear their braces correctly and consistently, so they can avoid worsening their condition.

Quick facts

Study typeInterventional
Ages8 Years to 17 Years
SexWomen only
Enrollment87 (estimated)
SponsorColumbia University
Academic / other
Locations1 site (New York, New York)
StatusRecruiting
StartedOctober 18, 2017
Main results expectedFebruary 2027
Study endsFebruary 2027
Registry record updatedApril 3, 2026
Trial IDNCT03292601 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adolescents diagnosed with adolescent idiopathic scoliosis who are recommended for Rigo bracing and are in skeletal stage 4 or earlier.

Probably not a fit

Patients who have undergone prior spine surgery may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to improve compliance with bracing for adolescent idiopathic scoliosis by utilizing a novel device and smartphone application that continuously measures brace tension and fit. By providing real-time feedback to patients and caregivers, the study seeks to enhance adherence to prescribed bracing regimens and gather data to establish optimal brace fit guidelines. The approach includes objective metrics to assess brace wear compliance and the potential impact of patient engagement through the app. The ultimate goal is to prevent scoliosis progression and reduce complications associated with improper brace use.

Why it matters

Potential benefit: If successful, this study could lead to improved brace compliance and better outcomes for adolescents with scoliosis.

How similar studies have gone: While some studies have explored brace tension, this approach of continuous monitoring and patient engagement through a smartphone app is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
* Sanders skeletal stage 4 or earlier
* Clinician-recommended Rigo bracing
* Patient receiving brace treatment

Exclusion Criteria:

\- Prior spine surgery

Where it's running

  • Morgan Stanley Children's Hospital of NY Presbyterian/Columbia University Medical Center
    New York, New York, United States
    Recruiting

Study contacts

  • Principal investigator: Benjamin Roye, MD, MPH — Columbia University
  • Study coordinator: Benjamin D. Roye, MD, MPH
  • Email: bdr5@columbia.edu
  • Phone: (212) 305-5475

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.