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Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)

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

Who can join

Ages 8 to 17 · Women

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

About the study

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.

What is being tested

• NYRC Brace Scoliosis Monitor (device)

Sponsor: Columbia University · Participants: 87 · Started: Oct 18, 2017

Contact the study team

• Benjamin D. Roye, MD, MPH · Phone: (212) 305-5475

Official record on ClinicalTrials.gov — NCT03292601

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.