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RecruitingNCT03292601

Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)

◆ AI Clinical Summary

This study tests a new device and smartphone app to track how often adolescents with scoliosis wear their back brace and how well the brace fits. By measuring brace usage and tension automatically, researchers hope to improve the effectiveness of bracing treatment for scoliosis.

Key Objective:The trial tests whether continuous monitoring of brace wear and fit can improve treatment outcomes for adolescent scoliosis patients.

Who to Consider:Adolescents with idiopathic scoliosis who are currently prescribed or considering brace treatment should consider enrolling.

Trial Parameters

ConditionAdolescent Idiopathic Scoliosis
SponsorColumbia University
Study TypeINTERVENTIONAL
PhaseN/A
Enrollment87
SexFEMALE
Min Age8 Years
Max Age17 Years
Start Date2017-10-18
Completion2027-02
Interventions
NYRC Brace Scoliosis Monitor

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Brief Summary

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.

Eligibility 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

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