Monitoring brace use for adolescents with scoliosis
Effect of Feedback and Monitoring on Patient Compliance With Spinal Orthoses for Scoliosis Treatment
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 87 (estimated) |
| Ages | 8 Years to 17 Years |
| Sex | Female |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT03292601 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who have undergone prior spine surgery may not benefit from this study.
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 performed: While some studies have explored brace tension, this approach of continuous monitoring and patient engagement through a smartphone app is relatively novel.
Eligibility criteria
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 this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.