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Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)

NCT03292601 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2026-04-03

No results posted yet for this study

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.

Conditions

  • Adolescent Idiopathic Scoliosis

Interventions

DEVICE

NYRC Brace Scoliosis Monitor

Scoliosis Monitor is a system that allows the continuous monitoring of the scoliosis brace use compliance and posture. This product includes a brace wearable that enables the monitoring of the scoliosis brace. The wearable device is able to communicate with a companion mobile application which stores and processes the collected data and is responsible for data synchronization.

Sponsors & Collaborators

  • Pediatric Orthopaedic Society of North America

    collaborator OTHER

  • Columbia University

    lead OTHER

Principal Investigators

  • Benjamin Roye, MD, MPH · Columbia University

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-18
Primary Completion
2027-02-28
Completion
2027-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03292601 on ClinicalTrials.gov