87 Participants Needed

Brace Monitoring for Adolescent Idiopathic Scoliosis

BD
Overseen ByBenjamin D. Roye, MD, MPH
Age: < 18
Sex: Female
Trial Phase: Academic
Sponsor: Columbia University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Research shows that using sensors and mobile apps can help improve how often and how long adolescents wear their scoliosis braces. These tools can monitor brace use and alert medical teams to any issues, potentially increasing adherence and improving treatment outcomes.23457

Who Is on the Research Team?

BR

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

You are currently using a brace for medical treatment.
Your doctor has recommended you wear a Rigo brace.
You have a Sanders skeletal stage 4 or earlier.
See 1 more

Exclusion Criteria

You had surgery on your spine before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a scoliosis brace fitted with a compliance-monitoring device and feedback mechanisms to improve brace wear compliance

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment, including wear time compliance and in-brace curve correction

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cinch Mobile App
  • Cinch Smart Strap
Trial Overview The study tests a new device called Cinch Smart Strap and an accompanying mobile app designed to monitor how well patients wear their scoliosis braces at home. It aims to improve compliance tracking and brace fit assessment through continuous tension measurements.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Feedback GroupExperimental Treatment1 Intervention
Participants will receive the standard-of-care scoliosis brace fitted with the compliance-monitoring study device and/or a temperature monitor (Orthotimer or iButton). The physician or a member of the research team will explain how the study device works to the patient and her/his parent. The physician or member of the research team will also explain the feedback mechanisms that exist to inform the patient that s/he has fit the device to the clinician-indicated appropriate tension and the online component of the program that allows for brace tension monitoring.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

Pediatric Orthopaedic Society of North America

Collaborator

Trials
8
Recruited
1,500+

Wellinks, Inc.

Collaborator

Trials
1
Recruited
20+

Citations

Influence of Specific Interventions on Bracing Compliance in Adolescents with Idiopathic Scoliosis-A Systematic Review of Papers Including Sensors' Monitoring. [2023]
mHealth for the Monitoring of Brace Compliance and Wellbeing in Adolescents with Idiopathic Scoliosis: Study Protocol for a Feasibility Study. [2021]
Quantitative measurement of spinal brace use and compliance in the treatment of adolescent idiopathic scoliosis. [2018]
Biomechanical evaluation of the Boston brace system for the treatment of adolescent idiopathic scoliosis: relationship between strap tension and brace interface forces. [2022]
A compliance real-time monitoring system for the management of the brace usage in adolescent idiopathic scoliosis patients: a pilot study. [2021]
Which interventions may improve bracing compliance in adolescent idiopathic scoliosis? A systematic review and meta-analysis. [2022]
Adolescents with idiopathic scoliosis and their parents have a positive attitude towards the Thermobrace monitor: results from a survey. [2022]
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