Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)
ConditionAdolescent Idiopathic Scoliosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age8-17
SponsorColumbia University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
Sanders skeletal stage 4 or earlier
Clinician-recommended Rigo bracing
Patient receiving brace treatment
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
NYRC Brace Scoliosis Monitor
DeviceScoliosis 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.
Treatment groups
87 Participants
are divided into 1 treatment groupGroup A: Feedback GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Wear Time Compliance
Measured as number of hours that the patient actually wore the brace.
Time frame
Up to 1 year2
Wear Compliance: Valid Hours
Measured as time (in hours) that the brace was worn to the provider-prescribed tightness
Time frame
Up to 1 year3
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).
Time frame
Up to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
Pediatric Orthopaedic Society of North America
Collaborator
Source ClinicalTrials.gov