Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)
Recruiting now · Not applicable
Conditions studied: Adolescent Idiopathic Scoliosis
In brief
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.
Key facts
- Study ID
- NCT03292601
- Run by
- Columbia University
- People needed
- 87
- Starts
- 2017-10-18
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2026-04-03
Who can join
Age: 8 and older, up to 17. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
- Sanders skeletal stage 4 or earlier
- Clinician-recommended Rigo bracing
- Patient receiving brace treatment
You may not qualify if…
- Prior spine surgery
Where it is running
- Morgan Stanley Children's Hospital of NY Presbyterian/Columbia University Medical Center — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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