Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)

Study Overview
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Brief Summary
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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.

Detailed Description
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The current method to set brace tension is subjective; it is limited to the attending clinician making a mark on the brace straps, to which the patient tightens the straps during daily wear. Once the strap is set in place, the current standard-of-care does not involve any more monitoring. Therefore, ideal strap tension is unknown and the effectiveness of bracing may be unknowingly compromised by many as yet unidentified variables. In recent years, a small number of studies have emerged related to the strap tension of bracing yet no clear guidelines on correct strap tension currently exist. Considering the potential effects on preventing scoliosis progression and brace-associated complications, the need for guidelines regarding optimal brace fit are greatly needed for clinical use. Via this brace monitoring study, continuous monitoring of tension at brace fitting, throughout the day, and related to positional changes will be possible with a very minimal device and smartphone application. The tremendous amounts of data generated by the device and its app will be used to create a database from which our team will gather information about brace wear compliance and use tension information for the development of standards for effective strap tension associated with greater scoliosis curve correction. Lastly, the effect of a patient's engagement with his or her brace - through the smartphone app - will be examined. It is well established in the literature that observation increases compliance, but no studies investigating patient self-monitoring through personal devices currently exists. This is a vital area of investigation given the recent explosion in personal health-assessing devices e.g. the Apple watch, Up band, fitbit, etc.

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

Conditions
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Adolescent Idiopathic Scoliosis

Intervention / Treatment
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* Device: Cinch Smart Strap
* Other: Cinch Mobile App


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: (No Feedback Group was removed in 2019)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feedback Group<br>Patients in the Feedback Group will receive their brace-wear (Cinch Smart Strap) compliance data via the Wellinks phone application (Cinch Mobile App). Patients will also receive their brace-wear compliance information at their standard of care follow-up visits. | Device: Cinch Smart Strap<br>* The study device is a small (with dimensions of 1.5 x 2 x 3/8 and weighing approximately 0.9-oz) Bluetooth-enabled and battery-powered monitor with Velcro strap that attaches to orthopaedic braces for scoliosis in place of the traditional strap and buckle. When the Velcro strap is tightened, the device measures tension in Newtons with the vector of force parallel to and away from the device, reflecting the pulling force required to keep the brace fitted on the patient.<br>* Other names: Cinch Smart Strap manufactured by Wellinks, Inc.;Other: Cinch Mobile App<br>* The Cinch App allows patients and parents to track and edit treatment information, sync data from the Cinch Smart Strap, and view compliance data. The app connects via Bluetooth to the Cinch Smart Strap and allows patients and parents save and sync data from the device.<br>* Other names: Cinch Mobile App by Wellinks, Inc.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Orthosis, Spinal Brace