Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)
Primary Purpose
Adolescent Idiopathic Scoliosis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cinch Smart Strap
Cinch Mobile App
Sponsored by
About this trial
This is an interventional device feasibility trial for Adolescent Idiopathic Scoliosis focused on measuring Spinal Orthosis, Spinal Brace
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
Sites / Locations
- Morgan Stanley Children's Hospital of NY Presbyterian/Columbia University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Feedback Group
Arm Description
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.
Outcomes
Primary Outcome Measures
Wear Time Compliance
Measured as number of hours that the patient actually wore the brace.
Wear Compliance: Valid Hours
Measured as time (in hours) that the brace was worn to the provider-prescribed tightness
In-Brace Curve Correction Rate
In-brace curve correction will be analyzed by an in-brace radiograph to determine the degree of immediate curve correction (absolute change in degrees).
Secondary Outcome Measures
Full Information
NCT ID
NCT03292601
First Posted
September 21, 2017
Last Updated
March 15, 2023
Sponsor
Columbia University
Collaborators
Wellinks, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03292601
Brief Title
Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)
Official Title
Effect of Feedback and Monitoring on Patient Compliance With Spinal Orthoses for Scoliosis Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
Collaborators
Wellinks, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The current method to set brace tension is subjective; it is limited to the attending clinician making a mark on the brace straps, to which the patient tightens the straps during daily wear. Once the strap is set in place, the current standard-of-care does not involve any more monitoring. Therefore, ideal strap tension is unknown and the effectiveness of bracing may be unknowingly compromised by many as yet unidentified variables. In recent years, a small number of studies have emerged related to the strap tension of bracing yet no clear guidelines on correct strap tension currently exist. Considering the potential effects on preventing scoliosis progression and brace-associated complications, the need for guidelines regarding optimal brace fit are greatly needed for clinical use. Via this brace monitoring study, continuous monitoring of tension at brace fitting, throughout the day, and related to positional changes will be possible with a very minimal device and smartphone application. The tremendous amounts of data generated by the device and its app will be used to create a database from which our team will gather information about brace wear compliance and use tension information for the development of standards for effective strap tension associated with greater scoliosis curve correction. Lastly, the effect of a patient's engagement with his or her brace - through the smartphone app - will be examined. It is well established in the literature that observation increases compliance, but no studies investigating patient self-monitoring through personal devices currently exists. This is a vital area of investigation given the recent explosion in personal health-assessing devices e.g. the Apple watch, Up band, fitbit, etc.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis
Keywords
Spinal Orthosis, Spinal Brace
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
(No Feedback Group was removed in 2019)
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Feedback Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cinch Smart Strap
Other Intervention Name(s)
Cinch Smart Strap manufactured by Wellinks, Inc.
Intervention Description
The study device is a small (with dimensions of 1.5" x 2" x 3/8" and weighing approximately 0.9-oz) Bluetooth-enabled and battery-powered monitor with Velcro strap that attaches to orthopaedic braces for scoliosis in place of the traditional strap and buckle. When the Velcro strap is tightened, the device measures tension in Newtons with the vector of force parallel to and away from the device, reflecting the pulling force required to keep the brace fitted on the patient.
Intervention Type
Other
Intervention Name(s)
Cinch Mobile App
Other Intervention Name(s)
Cinch Mobile App by Wellinks, Inc.
Intervention Description
The Cinch App allows patients and parents to track and edit treatment information, sync data from the Cinch Smart Strap, and view compliance data. The app connects via Bluetooth to the Cinch Smart Strap and allows patients and parents save and sync data from the device.
Primary Outcome Measure Information:
Title
Wear Time Compliance
Description
Measured as number of hours that the patient actually wore the brace.
Time Frame
Up to 1 year
Title
Wear Compliance: Valid Hours
Description
Measured as time (in hours) that the brace was worn to the provider-prescribed tightness
Time Frame
Up to 1 year
Title
In-Brace Curve Correction Rate
Description
In-brace curve correction will be analyzed by an in-brace radiograph to determine the degree of immediate curve correction (absolute change in degrees).
Time Frame
Up to 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin D. Roye, MD, MPH
Phone
(212) 305-5475
Email
bdr5@columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Roye, MD, MPH
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Morgan Stanley Children's Hospital of NY Presbyterian/Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Afrain Boby, MS
Phone
212-305-9367
Email
ab4789@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Hiroko Matsumoto, MA, PhDc
Phone
212-305-5028
Email
hm2174@cumc.columbia.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)
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