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NCT Number: NCT06474741

Using Technology 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.

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Key information

Conditions

Torticollis Dyskinesias Dystonia Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 day–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

in-app notification

Behavioral

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.

Primary outcomes

  1. symmetry score

    Time frame: baseline and 4 months

    extent of infant's head turn asymmetry

Secondary outcomes

  1. gaze asymmetry score

    Time frame: 6 months

    extent of infant's eye gaze asymmetry

  2. time spent in focused attention

    Time frame: 6 months

  3. # of bouts of focused attention

    Time frame: 6 months

  4. correlation between computer vision algorithm & manual coding for infants' head turns

    Time frame: 4 months

  5. Correlate computer vision score with clinical test of symmetry

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

College of Staten Island, the City University of New York

Other

Collaborators

  • Duquesne University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2024
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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