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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
Study 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.
Eligible Conditions
- Adolescent Idiopathic Scoliosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
In-Brace Curve Correction Rate
Wear Compliance: Valid Hours
Wear Time Compliance
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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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,811 Total Patients Enrolled
Wellinks, Inc.UNKNOWN
Benjamin Roye, MD, MPHPrincipal InvestigatorColumbia University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently using a brace for medical treatment.Your doctor has recommended you wear a Rigo brace.You had surgery on your spine before.You have a Sanders skeletal stage 4 or earlier.You have Adolescent Idiopathic Scoliosis (AIS).
Research Study Groups:
This trial has the following groups:- Group 1: Feedback Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Oklahoma
Texas
How old are they?
< 18
18 - 65
What site did they apply to?
Morgan Stanley Children's Hospital of NY Presbyterian/Columbia University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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