Using Technology for Prediction and Prevention of Infant Torticollis and Plagiocephaly

June 20, 2024 updated by: College of Staten Island, the City University of New York

Both Sides Now: Using Computer Vision and App-based Intervention for Prediction and Prevention of Infant Torticollis and Plagiocephaly

The goal of this clinical trial is to test whether an app-based intervention can reduce the likelihood of a torticollis diagnosis in infants. The main question[s] it aims to answer are:

  • whether an app can successfully deliver an intervention to parents of young infants
  • whether parents who learn about torticollis will increase behaviors intended to prevent torticollis compared to parents who learn about general infant development

Participants will complete a monthly survey for 6 months asking about their parenting behaviors. Researchers will compare parents who receive notifications about torticollis with parents who receive notifications about general infant development to see if increased knowledge of torticollis leads to preventive behavior.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

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.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • any parent with an infant under a month old who can answer a survey in English

Exclusion Criteria:

  • infant already has a diagnosis of torticollis or plagiocephaly

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention
in-app twice-weekly parent notification about torticollis and head turn asymmetries
Behavioral: in-app notification
Parents will receive bi-weekly prompts in a baby monitor app to change infant's orientation within crib, allow for tummy time several times per day, alternate the side from which infants are fed, alternate the side the infant faces during carrying, and in general note any side preferences of the infant so that positioning can assist in symmetry.
No Intervention: control
in-app twice-weekly parent notification about general infant development

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
symmetry score
Time Frame: baseline and 4 months
extent of infant's head turn asymmetry
baseline and 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gaze asymmetry score
Time Frame: 6 months
extent of infant's eye gaze asymmetry
6 months
time spent in focused attention
Time Frame: 6 months
6 months
# of bouts of focused attention
Time Frame: 6 months
6 months
correlation between computer vision algorithm & manual coding for infants' head turns
Time Frame: 4 months
4 months
Correlate computer vision score with clinical test of symmetry
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

College of Staten Island, the City University of New York

Collaborators

Duquesne 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 Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 20, 2024

First Submitted That Met QC Criteria

June 20, 2024

First Posted (Actual)

June 26, 2024

Study Record Updates

Last Update Posted (Actual)

June 26, 2024

Last Update Submitted That Met QC Criteria

June 20, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CStatenIslandCUNY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data that underlie results reported in published articles, after deidentification, as well as the study protocol, statistical analysis plan, and informed consent form, will be available beginning 9 months and ending 5 years following publication.

Only investigators whose proposed use of the data has been approved by a learned intermediary shall have access to conduct analyses as approved in the proposal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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