An observational study in Plagiocephaly, Cranial Defect and Orthosis, sponsored by Gulhane School of Medicine. Completed at 1 site in Turkey (Türkiye). Open to participants aged 3 Months to 18 Months. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Gulhane School of Medicine · Observational
This study aims to investigate the association between objective cranial morphological changes and parental expectations and satisfaction in infants undergoing treatment with a cranial remolding orthosis (CRO). Infants diagnosed with positional cranial deformities and prescribed CRO treatment will be included. Cranial morphological outcomes will be assessed using standardized cranial measurements obtained before and after the treatment period.
Parental treatment expectations will be evaluated prior to the initiation of CRO therapy using the Treatment Expectation Questionnaire (TR.TEX-Q), while parental satisfaction with the device and treatment process will be assessed at the end of treatment using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST).
The primary objective of the study is to examine the relationships between changes in cranial morphology and parental expectations and satisfaction scores. Secondary objectives include exploring the association between baseline expectations and post-treatment satisfaction. The findings are expected to provide insight into how objective treatment outcomes align with family-reported perceptions in cranial remolding orthosis therapy.
16 studies on the registry are indexed under Plagiocephaly; 4 are open to participants now.
Browse Plagiocephaly studies →Gulhane School of Medicine is the lead sponsor of 67 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study includes infants aged 3-18 months with cranial deformities who have been recommended helmet therapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Infants presenting with cranial deformities characterized by abnormal cranial shape or asymmetry during early infancy, including deformities affecting cranial symmetry, cranial proportions, and head contour. Participants are infants within the period of rapid cranial growth, for whom cranial remolding orthosis treatment is clinically indicated. The cohort includes infants of both sexes, with varying degrees of cranial deformity severity, and without neurological or syndromic conditions that could affect cranial growth. All infants are otherwise medically stable and suitable for conservative orthotic management.
Device: Cranial orthosis
The intervention consisted of treatment with a custom-fabricated cranial remolding orthosis (CRO). Each orthosis was individually designed based on the infant's cranial shape using three-dimensional cranial scanning and computer-aided modeling. A mold was produced using CNC technology, and a thermoplastic material was formed over the mold to create the final orthosis. The fabricated CRO was delivered to the clinic within a few days and fitted to the infant. During the initial fitting, the orthosis was clinically inspected for proper fit and for any signs of skin redness, irritation, or pressure-related issues. Necessary adjustments were made, and parents were provided with detailed instructions regarding orthosis use and care. Infants were subsequently scheduled for regular clinical follow-up, and only custom-fabricated cranial remolding orthoses were included in the study.
Change in cranial morphological measurements following cranial remolding orthosis treatment
The primary outcome measure is the change in cranial morphology assessed by standardized anthropometric measurements obtained before and after cranial remolding orthosis (CRO) treatment. Cranial measurements include anterior-posterior and medio-lateral dimensions, right and left frontal measurements, and head circumference. Changes in these measurements are used to quantify objective cranial morphological improvement over the course of treatment.
Time frame: Periprocedural
Parental treatment expectations
Parental expectations regarding cranial remolding orthosis treatment are assessed before initiation of treatment using the Treatment Expectation Questionnaire. This measure evaluates parents' expectations related to treatment outcomes, process, and perceived benefits prior to intervention.The Treatment Expectation Questionnaire is a generic, multidimensional patient-reported outcome measure consisting of 15 items assessing expectations across multiple domains of treatment. Each item is rated on a numerical scale from 0 (no expected change) to 10 (maximum expected change), yielding a total score range of 0 to 150, with higher scores indicating greater treatment expectations.
Time frame: baseline
Parental satisfaction
Parental satisfaction with cranial remolding orthosis treatment is assessed after completion of the treatment period using the Quebec User Evaluation of Satisfaction with Assistive Technology. This measure evaluates satisfaction with the cranial remolding orthosis in terms of device-related characteristics and overall satisfaction with the assistive technology.
Time frame: Periprocedural
Plan to share: No
Ran from Nov 2025 to primary completion in Feb 2026, 2 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Gulhane School of Medicine