RecruitingNot ApplicableNCT03292601

Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)

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


Sponsor

Columbia University

Enrollment

87 participants

Start Date

Oct 18, 2017

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 8 YearsMax Age: 17 Years

Inclusion Criteria4

  • Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
  • Sanders skeletal stage 4 or earlier
  • Clinician-recommended Rigo bracing
  • Patient receiving brace treatment

Exclusion Criteria1

  • \- Prior spine surgery

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICENYRC 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.


Locations(1)

Morgan Stanley Children's Hospital of NY Presbyterian/Columbia University Medical Center

New York, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03292601


Related Trials