NCT03292601 Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)
| NCT ID | NCT03292601 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Adolescent Idiopathic Scoliosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 87 participants |
| Start Date | 2017-10-18 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 87 participants in total. It began in 2017-10-18 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * Diagnosis of Adolescent Idiopathic Scoliosis (AIS) * Sanders skeletal stage 4 or earlier * Clinician-recommended Rigo bracing * Patient receiving brace treatment Exclusion Criteria: \- Prior spine surgery
Contact & Investigator
Benjamin Roye, MD, MPH
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT03292601 clinical trial?
This trial is open to female participants only, aged 8 Years or older, up to 17 Years, studying Adolescent Idiopathic Scoliosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03292601 currently recruiting?
Yes, NCT03292601 is actively recruiting participants. Contact the research team at bdr5@columbia.edu for enrollment information.
Where is the NCT03292601 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT03292601 clinical trial?
NCT03292601 is sponsored by Columbia University. The principal investigator is Benjamin Roye, MD, MPH at Columbia University. The trial plans to enroll 87 participants.