Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT03292601
Status
Recruiting
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Conditions

  • Adolescent Idiopathic Scoliosis

Eligibility Criteria

Sex
FEMALE
Age
8 Years - 17 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Oct 18, 2017
Status verified
Mar 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
87 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

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.

Primary Outcome Measure

Wear Time Compliance [ Time Frame: Up to 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Morgan Stanley Children's Hospital of NY Presbyterian/Columbia University Medical CenterNew YorkNew York10032
Mehdi Elfilali, BA
[email protected]
212-305-9367
Nicole Bainton
[email protected]
212-305-5475

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By research site
Morgan Stanley Children's Hospital of NY Presbyterian/Columbia University Medical Center· New York, NY

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