Actively Recruiting
Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)
Led by Columbia University · Updated on 2026-04-03
87
Participants Needed
1
Research Sites
484 weeks
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
The overall aim of the study is to utilize a novel device and smartphone application in order to improve measurement of patient compliance with at-home bracing for scoliosis as well as create a more accurate assessment of brace fit via continuous and objective measures of tension. These ground-breaking metrics will provide analyzable data to more accurately reflect and predict actual patient compliance as well as allow for further exploration of how to increase compliance, and thus, efficacy of bracing; it will additionally allow both physicians and patients to have a more reliable measure for brace fit by providing them with continuous data of fit via tension, and provide built-in feedback mechanisms to the patient to ensure proper tightness of the brace. Additionally, the study will investigate whether providing the wearer's own brace-wear compliance information directly to the patient and their caregiver(s) via the mobile app will further improve rates of compliance as compared to those who do not receive the same feedback mechanism.
CONDITIONS
Official 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
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
CONTACT
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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