Brace Monitoring for Adolescent Idiopathic Scoliosis

Recruiting in Palo Alto (17 mi)

Overseen byBenjamin Roye, MD, MPH

Age: < 18

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Columbia University

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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.

+1 more

Exclusion Criteria

You had surgery on your spine before.

Participant Groups

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.

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.