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 type | Interventional |
|---|---|
| Ages | 8 Years to 17 Years |
| Sex | Women only |
| Enrollment | 87 (estimated) |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | October 18, 2017 |
| Main results expected | February 2027 |
| Study ends | February 2027 |
| Registry record updated | April 3, 2026 |
| Trial ID | NCT03292601 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.
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Comfort Tote to help recovery after scoliosis surgery in teens
This study tests whether a therapeutic Comfort Tote can reduce pain and anxiety after surgery for adolescent idiopathic scoliosis.
-
Erector spinae plane block to reduce post-operative pain after posterior spinal fusion in children
This will try giving an erector spinae plane block with ropivacaine to see if it reduces pain and the need for opioid pain medicine after posterior spinal fusion in children with adolescent idiopathic or neuromuscular scoliosis.
-
MRI-guided dynamic support for correcting adolescent scoliosis
This pilot tests whether an MRI-compatible air-padded support with programmable pneumatic control can quickly reduce spinal curvature in 10–16-year-olds with mild to moderate adolescent idiopathic scoliosis.
-
Detecting scoliosis progression without X-rays using Momentum Spine app
This study tests whether the Momentum Spine app can reliably detect scoliosis progression in 8-18 year olds without radiographs and guide follow-up care.
-
Examining how spinal manipulation affects motor control in adolescents with scoliosis
This study is testing how spinal manipulation affects movement control in teenagers with scoliosis to see if it helps them improve their balance and muscle function.
-
Using a 3D camera to assess scoliosis in adolescents
This study is testing a new way to check the spine of teenagers with scoliosis using a special 3D camera to see if it’s better and safer than traditional X-rays.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.