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TorticollisNCT06474741

Using Technology for Prediction and Prevention of Infant Torticollis and Plagiocephaly

A study testing in-app notification in people with Torticollis, run by College of Staten Island, the City University of New York.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 1 day to 1 monthHealthy volunteers can take part
Conditions the study is for
Torticollis
What is being tested?
in-app notification
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
No sites listed yet
Study dates
Jun 2025to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 1 month
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • infant already has a diagnosis of torticollis or plagiocephaly

About this study

Official title: 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.

Conditions
Torticollis
Being tested
in-app notification
Keywords
prevention
Medical subject headings
Torticollis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • in-app notificationBehavioural

    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.

Study groups in NCT06474741
Study groupRoleWhat they receive
interventionExperimentalin-app twice-weekly parent notification about torticollis and head turn asymmetries
Receives: Behavioral: in-app notification
controlNo interventionin-app twice-weekly parent notification about general infant development

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. symmetry score

    extent of infant's head turn asymmetry

    Measured: baseline and 4 months

Secondary outcomes (5)

  1. gaze asymmetry score

    extent of infant's eye gaze asymmetry

    Measured: 6 months

  2. time spent in focused attention

    Measured: 6 months

  3. # of bouts of focused attention

    Measured: 6 months

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

    Measured: 4 months

  5. Correlate computer vision score with clinical test of symmetry

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2024
  2. Study startJun 2025 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06474741
Sponsor's protocol ID
CStatenIslandCUNY
Status last verified
Jun 2024
First submitted
20 Jun 2024
Last updated
26 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Questions about this trial

What is this clinical trial studying?

A study testing in-app notification in people with Torticollis, run by College of Staten Island, the City University of New York.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

symmetry score (time frame: baseline and 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06474741.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.

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