Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)
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.
Conditions:
🦠 Adolescent Idiopathic Scoliosis
🗓️ Study Start (Actual) 18 October 2017
🗓️ Primary Completion (Estimated) January 2025
✅ Study Completion (Estimated) January 2025
👥 Enrollment (Estimated) 20
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

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

🗓️ 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

  • First Submitted 21 September 2017
  • First Submitted that Met QC Criteria 21 September 2017
  • First Posted 25 September 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 May 2024
  • Last Update Posted 13 May 2024
  • Last Verified May 2024