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Helmet therapy for babies: do parent hopes match reality?

NCT ID NCT07356401

Knowledge-focused Sponsor: Gulhane School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

This study looks at 20 infants with flat head syndrome (plagiocephaly) who use a custom helmet. Researchers measure changes in head shape and ask parents about their hopes before treatment and their satisfaction after. The goal is to see if objective improvements align with what families expect and feel about the therapy.

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.

Participants

10 people

The number who actually took part.

Started

Nov 2025

Finished

Mar 2026

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.

Who is studied

The study includes infants aged 3-18 months with cranial deformities who have been recommended helmet therapy.

Ages

3 to 18 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Infants diagnosed with positional cranial deformities (e.g., plagiocephaly, brachycephaly, or asymmetrical cranial shape) * Infants who received cranial remolding orthosis treatment * Use of a custom-made cranial remolding orthosis * Availability of pre-treatment and post-treatment cranial measurements * Parents or legal guardians who provided informed consent and were able to complete expectation and satisfaction questionnaires * Infants who completed the planned cranial remolding orthosis treatment and follow-up period Exclusion Criteria: * Infants with neurological disorders, genetic syndromes, or congenital conditions affecting cranial growth * Infants who underwent previous cranial surgery or other cranial interventions * Infants who received non-custom-made or prefabricated cranial orthoses * Incomplete clinical records or missing pre- or post-treatment cranial measurements * Parents or caregivers unable to complete the questionnaires due to language or cognitive limitations * Infants with a diagnosis of microcephaly or macrocéphaly.

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Conditions

The condition(s) this trial relates to.

Personal Satisfaction Plagiocephaly

As listed by the trial registrant

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

Cranial defect Expectancy Orthosis Plagiocephaly Satisfaction

Contacts and locations

Locations

  • University of Health Sciences Gülhane Faculty of Health Sciences

    Ankara, Keçiören, 06010, Turkey (Türkiye)

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