Brace Monitoring for Adolescent Idiopathic Scoliosis

Overseen By Benjamin D. Roye, MD, MPH

Age: < 18

Sex: Female

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Prior spine surgery

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1 year

87 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist teens with adolescent idiopathic scoliosis (a type of spine curvature) by using a new device and smartphone app, the Cinch Smart Strap and Cinch Mobile App. The goal is to measure how well patients adhere to wearing their back braces at home and ensure proper brace fit. The study will test whether showing patients and their caregivers their brace-wear information through the app increases compliance. Teens diagnosed with scoliosis and recommended to wear a Rigo brace may be suitable for this trial. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance scoliosis treatment adherence.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this device is safe for monitoring scoliosis brace compliance?

Research has shown that brace monitoring systems, such as the Cinch Mobile App and Smart Strap, are safe for teenagers. Studies have found these tools easy to use and effective in spotting problems early, allowing for quick action. They enhance the effectiveness of braces and enable doctors to monitor treatment remotely. Overall, evidence suggests these devices are safe and support scoliosis treatment by encouraging better brace-wearing habits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cinch Mobile App and Cinch Smart Strap because they bring a tech-savvy twist to managing adolescent idiopathic scoliosis. Unlike traditional braces, which rely solely on manual adjustments and patient compliance, these innovative tools incorporate real-time feedback and monitoring. The Cinch Smart Strap allows users to ensure their brace is fitted correctly through tension monitoring, while the Cinch Mobile App provides an online platform for tracking and adjustments. This combination aims to improve patient adherence and outcomes by making brace-wearing more interactive and precise.

What evidence suggests that this device and app are effective for improving brace compliance in scoliosis?

Research has shown that mobile health tools, such as the Cinch Mobile App and Smart Strap, can help teenagers with scoliosis wear their braces more consistently. In this trial, participants in the Feedback Group will use these tools to track brace use, identifying problems early and allowing for quick solutions. The app also appears to enhance users' feelings about their treatment, with some experiencing improved emotional well-being. By providing feedback on brace fit and usage frequency, these tools aim to help patients adhere to their treatment plans more effectively, which is crucial for managing scoliosis. ^{1 2 3 4 6}

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

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.

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?

Group I: Feedback Group Experimental Treatment 1 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.

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

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12470586/

Utilizing Mobile Health Technology to Enhance Brace ... The app supported early detection of treatment barriers and prompted timely clinical responses. Despite limitations, it shows promise as a tool ...

2. withpower.com withpower.com/trial/phase-scoliosis-9-2017-b58f6

Brace Monitoring for Adolescent Idiopathic Scoliosis 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10003789/

Mobile Apps to Improve Brace-Wearing Compliance in ... This study was performed to review which mHealth apps that improve brace-wearing compliance are currently available, and to carry out their quality assessments.

4. researchgate.net researchgate.net/publication/395189507_Utilizing_Mobile_Health_Technology_to_Enhance_Brace_Compliance_Feasibility_and_Effectiveness_of_an_App-Based_Monitoring_System_for_Adolescents_with_Idiopathic_Scoliosis

Utilizing Mobile Health Technology to Enhance Brace ... Improvements of ≥20% in psychological outcomes were observed in 20–26.7% of participants, while group-level changes were nonsignificant.

5. semanticscholar.org semanticscholar.org/paper/Utilizing-Mobile-Health-Technology-to-Enhance-Brace-S%C3%A1nchez-Raya-Salat-Batlle/f07651ea8fc10bef2e45c90cc73873cec677a1df

Utilizing Mobile Health Technology to Enhance Brace ... Utilizing Mobile Health Technology to Enhance Brace Compliance: Feasibility and Effectiveness of an App-Based Monitoring System for Adolescents with Idiopathic ...

6. mdpi.com mdpi.com/2306-5354/12/7/696

Wearable Devices in Scoliosis Treatment: A Scoping ... The literature shows that the use of wearable devices can enhance scoliosis treatment by improving the efficiency of braces and enabling remote monitoring in ...