Clinical trial NCT03292601: Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)
Official title: Effect of Feedback and Monitoring on Patient Compliance With Spinal Orthoses for Scoliosis Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Keywords: Spinal Orthosis
Spinal Brace
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Pediatric Orthopaedic Society of North America
First posted: 2017-09-25
Enrollment: 87
Sex: FEMALE
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: (No Feedback Group was removed in 2019)
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Wear Time Compliance
timeFrame: Up to 1 year
measure: Wear Compliance: Valid Hours
timeFrame: Up to 1 year
measure: In-Brace Curve Correction Rate
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Morgan Stanley Children's Hospital of NY Presbyterian/Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Benjamin Roye, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: