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Can a helmet or simple repositioning reshape an Infant's head?

NCT ID NCT05917678

Disease control Sponsor: University of Texas Southwestern Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests two ways to correct flat head syndrome in infants: caregiver-led repositioning and a custom-fit helmet. Researchers will measure head shape changes in treated infants and compare them with a group of typically developing infants. Infants with torticollis will also receive physical therapy. The goal is to see which approach, if either, leads to better head shape correction.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Repositioning therapy and a custom cranial remolding orthosis (helmet)
What this could lead to
If it works, this could clarify which treatment, repositioning or a helmet, more effectively corrects flat head syndrome in infants.
What could go wrong
This is a small, early-stage study, and results may not apply to all infants. Helmet therapy requires consistent wear and regular adjustments, which can be challenging.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 65 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 3 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria for Control Group: * Healthy infants with normal physical development and no need for physical therapy intervention Exclusion Criteria for Control Group: * Infants with abnormal head shapes (plagiocephaly or craniosynostosis) * Infants with growth abnormalities (such as genetic conditions) * Infants with developmental delay significant to warrant physical therapy or occupational therapy

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Conditions

The condition(s) this trial relates to.

craniosynostosis inherited torticollis Plagiocephaly Plagiocephaly, Nonsynostotic Torticollis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brachycephaly Congenital muscular torticollis Deformational plagiocephaly Deformational posterior plagiocephaly Torticollis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

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