Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03292601
• Other study ID #: AAAP4760
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2017
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: Columbia University
• Contact: Benjamin D. Roye, MD, MPH
• Phone: (212) 305-5475
• Email: bdr5[@]columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

Device:
• Cinch Smart Strap
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.

Other:
• Cinch Mobile App
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.

Locations

Country	Name	City	State
United States	Morgan Stanley Children's Hospital of NY Presbyterian/Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Wellinks, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wear Time Compliance	Measured as number of hours that the patient actually wore the brace.	Up to 1 year
Primary	Wear Compliance: Valid Hours	Measured as time (in hours) that the brace was worn to the provider-prescribed tightness	Up to 1 year
Primary	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