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Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)

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ClinicalTrials.gov Identifier: NCT03292601
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : October 20, 2017
Sponsor:
Collaborator:
Wellinks, Inc.
Information provided by (Responsible Party):
Benjamin Roye, Columbia University

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.


Condition or disease Intervention/treatment Phase
Adolescent Idiopathic Scoliosis Device: Cinch Smart Strap Other: Cinch Mobile App Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Effect of Feedback and Monitoring on Patient Compliance With Spinal Orthoses for Scoliosis Treatment
Actual Study Start Date : October 18, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arm Intervention/treatment
Active Comparator: Feedback Group
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.
Device: Cinch Smart Strap
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.
Other Name: Cinch Smart Strap manufactured by Wellinks, Inc.

Other: Cinch Mobile App
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.
Other Name: Cinch Mobile App by Wellinks, Inc.

Sham Comparator: No Feedback Group
Patients in the Feedback Group will not receive brace-wear (Cinch Smart Strap) compliance data via the Wellinks phone application. Patients will receive their brace-wear compliance information at their standard of care follow-up visits.
Device: Cinch Smart Strap
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.
Other Name: Cinch Smart Strap manufactured by Wellinks, Inc.




Primary Outcome Measures :
  1. Wear Time Compliance [ Time Frame: Up to 1 year ]
    Measured as number of hours that the patient actually wore the brace.

  2. Wear Compliance: Valid Hours [ Time Frame: Up to 1 year ]
    Measured as time (in hours) that the brace was worn to the provider-prescribed tightness

  3. In-Brace Curve Correction Rate [ Time Frame: Up to 1 year ]
    In-brace curve correction will be analyzed by an in-brace radiograph to determine the degree of immediate curve correction (absolute change in degrees).



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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292601


Contacts
Contact: Benjamin D. Roye, MD, MPH (212) 305-5475 bdr5@columbia.edu

Locations
United States, New York
Morgan Stanley Children's Hospital of NY Presbyterian/Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Fay Callejo, MPH         
Sponsors and Collaborators
Columbia University
Wellinks, Inc.
Investigators
Principal Investigator: Benjamin Roye, MD, MPH Columbia University

Responsible Party: Benjamin Roye, Assistant Professor of Orthopedic Surgery at the Columbia University Medical Center, Columbia University
ClinicalTrials.gov Identifier: NCT03292601     History of Changes
Other Study ID Numbers: AAAP4760
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Benjamin Roye, Columbia University:
Spinal Orthosis
Spinal Brace

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases