Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)

Not Applicable

Recruiting

• Conditions: Adolescent Idiopathic Scoliosis
• Interventions: Device: Cinch Smart Strap; Other: Cinch Mobile App

• Registration Number: NCT03292601
• Lead Sponsor: Columbia University

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-09-21
• Study First Submitted QC: 2017-09-21
• Study First Posted: 2017-09-25
• Study Start: 2017-10-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-13
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
• Sanders skeletal stage 4 or earlier
• Clinician-recommended Rigo bracing
• Patient receiving brace treatment

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Exclusion Criteria

• Prior spine surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Feedback Group	Cinch Smart Strap	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.
Feedback Group	Cinch Mobile App	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.

Primary Outcome Measures

Name	Time	Method
Wear Time Compliance	Up to 1 year	Measured as number of hours that the patient actually wore the brace.
Wear Compliance: Valid Hours	Up to 1 year	Measured as time (in hours) that the brace was worn to the provider-prescribed tightness
In-Brace Curve Correction Rate	Up to 1 year	In-brace curve correction will be analyzed by an in-brace radiograph to determine the degree of immediate curve correction (absolute change in degrees).

Trial Locations

Locations (1)

Morgan Stanley Children's Hospital of NY Presbyterian/Columbia University Medical Center; 🇺🇸 New York, New York, United States