Scoliosis Clinical Trials

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Effect of Feedback and Monitoring on Patient Compliance With Spinal Orthoses for Scoliosis Treatment

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 8
Maximum Age: 17
Healthy Volunteers: f
View:

• Diagnosis of Adolescent Idiopathic Scoliosis (AIS)

• Sanders skeletal stage 4 or earlier

• Clinician-recommended Rigo bracing

• Patient receiving brace treatment

Locations
United States
New York
Morgan Stanley Children's Hospital of NY Presbyterian/Columbia University Medical Center
RECRUITING
New York
Contact Information
Primary
Benjamin D. Roye, MD, MPH
bdr5@columbia.edu
(212) 305-5475
Time Frame
Start Date: 2017-10-18
Estimated Completion Date: 2027-02
Participants
Target number of participants: 87
Treatments
Experimental: Feedback Group
Participants will receive the standard-of-care scoliosis brace fitted with the compliance-monitoring study device and/or a temperature monitor (Orthotimer or iButton). The physician or a member of the research team will explain how the study device works to the patient and her/his parent. The physician or member of the research team will also explain the feedback mechanisms that exist to inform the patient that s/he has fit the device to the clinician-indicated appropriate tension and the online component of the program that allows for brace tension monitoring.
Related Therapeutic Areas
Sponsors
Leads: Columbia University
Collaborators: Pediatric Orthopaedic Society of North America

This content was sourced from clinicaltrials.gov