Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)

NCT03292601 | Recruiting FDA Device

• 1 other identifier: AAAP4760
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Spinal Orthosis; Spinal Brace

Outcome Measures

Primary Outcomes (3)

• Wear Time Compliance

  Measured as number of hours that the patient actually wore the brace.

  Up to 1 year

• Wear Compliance: Valid Hours

  Measured as time (in hours) that the brace was worn to the provider-prescribed tightness

  Up to 1 year

• In-Brace Curve Correction Rate

  In-brace curve correction will be analyzed by an in-brace radiograph to determine the degree of immediate curve correction (absolute change in degrees).

  Up to 1 year

Study Arms (1)

Feedback Group

EXPERIMENTAL

Participants will receive the standard-of-care scoliosis brace fitted with the compliance-monitoring study device and/or a temperature monitor (Orthotimer or iButton). The physician or a member of the research team will explain how the study device works to the patient and her/his parent. The physician or member of the research team will also explain the feedback mechanisms that exist to inform the patient that s/he has fit the device to the clinician-indicated appropriate tension and the online component of the program that allows for brace tension monitoring.

Device: NYRC Brace Scoliosis Monitor

Interventions

NYRC Brace Scoliosis Monitor DEVICE

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.

Also known as: Monitor

Feedback Group

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Columbia University: lead
• Pediatric Orthopaedic Society of North America: collaborator

Study Sites (1)

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

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Interventions

Monitoring, Physiologic

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Benjamin Roye, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin D. Roye, MD, MPH

CONTACT

(212) 305-5475; bdr5@columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: (No Feedback Group was removed in 2019)

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 25, 2017
• Study Start: October 18, 2017
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

US (1)