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Brace Monitoring for Adolescent Idiopathic Scoliosis

N/A

Recruiting

Led By Benjamin Roye, MD, MPH

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will use a new device and smartphone app to improve measurement of patient compliance with at-home bracing for scoliosis and create a more accurate assessment of brace fit.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-invasive monitoring tools rather than medication, traditional side effects aren't expected. However, there may be discomfort from wearing the smart strap or psychological impacts from constant compliance monitoring.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

In-Brace Curve Correction Rate

Wear Compliance: Valid Hours

Wear Time Compliance

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Feedback GroupExperimental Treatment2 Interventions

Patients in the Feedback Group will receive their brace-wear (Cinch Smart Strap) compliance data via the Wellinks phone application (Cinch Mobile App). Patients will also receive their brace-wear compliance information at their standard of care follow-up visits.

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