What this study is
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.
What's being tested
- NYRC Brace Scoliosis Monitor
Intervention · 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
- Official title
- Effect of Feedback and Monitoring on Patient Compliance With Spinal Orthoses for Scoliosis Treatment
- Sponsor
- Columbia University
- Conditions
- Adolescent Idiopathic Scoliosis
- Enrolling
- 87 people
- Starts
- 2017-10-18
- Est. completion
- 2027-02
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 8 Years – 17 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
- Sanders skeletal stage 4 or earlier
- Clinician-recommended Rigo bracing
- Patient receiving brace treatment
You can't join if
- Prior spine surgery
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMorgan Stanley Children's Hospital of NY Presbyterian/Columbia University Medical Center
New York, New York, United States
- Mehdi Elfilali, BA · Contact212-305-9367Mme2145@cumc.columbia.edu
- Nicole Bainton · Contact212-305-5475nme2103@cumc.columbia.edu
Recruiting
Study team
Sponsor
Columbia University
Study ID AAAP4760
Principal investigator
Benjamin Roye, MD, MPH
Columbia University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.