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NCT03292601 · ClinicalTrials.gov registry record · NA
Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)
A NA study of Adolescent Idiopathic Scoliosis, sponsored by Columbia University.
- Recruiting
- Registry status
- NA
- Development phase
- 87
- Enrollment target
- 1
- Study location
NCT03292601: Recruiting NA study of Adolescent Idiopathic Scoliosis, sponsored by Columbia University.
NCT03292601 is a NA study of Adolescent Idiopathic Scoliosis that is actively recruiting participants, run by Columbia University. The registered enrollment target is 87 participants, below the 266-participant average among 7 other Adolescent Idiopathic Scoliosis trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03292601, a NA study of Adolescent Idiopathic Scoliosis, is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- NA
- Development phase
- 87 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Measured as number of hours that the patient actually wore the brace.
Conditions Studied
Interventions
- DEVICE NYRC Brace Scoliosis Monitor
Study Locations (1)
New York
- Morgan Stanley Children's Hospital of NY Presbyterian/Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2017-10-18 |
| Est. Completion | 2026-01 |
| Phase | NA |
What NCT03292601 shows while recruiting
NCT03292601 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 266-participant average among 7 other Adolescent Idiopathic Scoliosis trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Adolescent Idiopathic Scoliosis appearing as the primary indexed condition, and to 1 intervention - of which NYRC Brace Scoliosis Monitor is the first listed.
NCT03292601 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03292601 about?
NCT03292601 is a clinical study titled "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-break...
What is the current status of trial NCT03292601?
This trial is currently recruiting. It is a NA study. The enrollment target is 87 participants. The study started on 2017-10-18. Estimated completion is 2026-01.
What conditions does trial NCT03292601 study?
This clinical trial studies the following conditions: Adolescent Idiopathic Scoliosis.
What interventions are being tested in trial NCT03292601?
The interventions under investigation include: NYRC Brace Scoliosis Monitor (DEVICE).
Who is sponsoring clinical trial NCT03292601?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03292601 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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