Recruiting

Observational Study

Sponsor:

Columbia University

Code:

NCT03292601

Conditions

Adolescent Idiopathic Scoliosis

Eligibility Criteria

Sex: Female

Age: 8 - 17

Healthy Volunteers: Not accepted

Interventions

NYRC Brace Scoliosis Monitor

Study Details

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

Study ID

NCT03292601

Start date

Oct 18, 2017

Status verified date

Mar, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 8 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

87 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Feedback Group

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.

Interventions

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.

Primary outcome measure

  • Wear Time Compliance [ Time Frame: Up to 1 year ]
  • Wear Compliance: Valid Hours [ Time Frame: Up to 1 year ]
  • In-Brace Curve Correction Rate [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Benjamin D. Roye, MD, MPH

(212) 305-5475bdr5@columbia.edu

Locations

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

Recruiting

New York, New York, United States, 10032

Contacts

Mehdi Elfilali, BA

212-305-9367Mme2145@cumc.columbia.edu

Nicole Bainton

212-305-5475nme2103@cumc.columbia.edu

More Information

Sponsor

Columbia University

Last update posted

Apr 3, 2026

Last verified

Mar, 2026

Keywords

  • Spinal Orthosis
  • Spinal Brace

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-04-03.