Brace Monitoring for Adolescent Idiopathic Scoliosis
What You Need to Know Before You Apply
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
Is the brace monitoring system safe for use in humans?
The studies reviewed do not report any specific safety concerns related to the use of brace monitoring systems, such as sensors or mobile apps, in adolescents with idiopathic scoliosis. These systems are primarily used to track brace compliance and do not appear to pose any direct risks to users.12345
How does brace monitoring differ from other treatments for adolescent idiopathic scoliosis?
Brace monitoring for adolescent idiopathic scoliosis is unique because it uses sensors and mobile apps to objectively track how often and how long a brace is worn, which helps improve adherence and allows for real-time feedback to the medical team. This approach differs from traditional methods that rely on self-reported data, which can be inaccurate.23456
What data supports the effectiveness of the treatment Cinch Mobile App and Cinch Smart Strap for adolescent idiopathic scoliosis?
Who Is on the Research Team?
Benjamin Roye, MD, MPH
Principal Investigator
Columbia University
Are You a Good Fit for This Trial?
This trial is for young people who are currently being treated with a brace for Adolescent Idiopathic Scoliosis (AIS) and have not had prior spine surgery. They should be in the Sanders skeletal stage 4 or earlier, which means their bones are still growing, and must be recommended Rigo bracing by a clinician.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a scoliosis brace fitted with a compliance-monitoring device and feedback mechanisms to improve brace wear compliance
Follow-up
Participants are monitored for safety and effectiveness after treatment, including wear time compliance and in-brace curve correction
What Are the Treatments Tested in This Trial?
Interventions
- Cinch Mobile App
- Cinch Smart Strap
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
Pediatric Orthopaedic Society of North America
Collaborator
Wellinks, Inc.
Collaborator