RECRUITING

Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2017-10-18
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03292601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 17 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
  2. * Sanders skeletal stage 4 or earlier
  3. * Clinician-recommended Rigo bracing
  4. * Patient receiving brace treatment
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

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

Principal Investigator

Benjamin Roye, MD, MPH
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Morgan Stanley Children's Hospital of NY Presbyterian/Columbia University Medical Center
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Benjamin Roye, MD, MPH, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-10-18
Study Completion Date2025-01

Study Record Updates

Study Start Date2017-10-18
Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

  • Spinal Orthosis
  • Spinal Brace

Additional Relevant MeSH Terms

  • Adolescent Idiopathic Scoliosis