PlagiocephalyNCT07356401
Associations of Cranial Outcomes and Parental Expectations and Satisfaction
An observational study of Plagiocephaly and Cranial Defect, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 18 months
- Conditions the study is for
- Plagiocephaly, Cranial Defect, Orthosis
- What is being tested?
- Cranial orthosis
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Nov 2025to 15 Mar 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 to 18 months
- All sexes
- No healthy volunteers
- Child
Study population: The study includes infants aged 3-18 months with cranial deformities who have been recommended helmet therapy.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Gülhane Faculty of Health Sciences
Ankara, Keçiören, 06010
About this study
Official title: Association Between Cranial Morphological Changes, Parental Expectations, and Satisfaction Following Cranial Remolding Orthosis Treatment in Infants
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.
- Conditions
- Plagiocephaly, Cranial Defect, Orthosis, Expectancy, Satisfaction
- Being tested
- Cranial orthosis
- Medical subject headings
- Plagiocephaly, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial orthosisDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| infant with cranial deformity | 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. Receives: Device: Cranial orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline
Secondary outcomes (1)
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.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start25 Nov 2025
- Primary completion15 Feb 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PlagiocephalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güllü Aydın Yağcıoğlu, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356401
- Sponsor's protocol ID
- cranial orthosis
- Status last verified
- Nov 2025
- First submitted
- 13 Jan 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee HS, Kim SJ, Kwon JY. Parents' Perspectives and Clinical Effectiveness of Cranial-Molding Orthoses in Infants With Plagiocephaly. Ann Rehabil Med. 2018 Oct;42(5):737-747. doi: 10.5535/arm.2018.42.5.737. Epub 2018 Oct 31.
PubMed 30404423McGarry A, Dixon MT, Greig RJ, Hamilton DR, Sexton S, Smart H. Head shape measurement standards and cranial orthoses in the treatment of infants with deformational plagiocephaly. Dev Med Child Neurol. 2008 Aug;50(8):568-76. doi: 10.1111/j.1469-8749.2008.03017.x.
PubMed 18754893
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Cranial Morphological Changes, Parental Expectations, and Satisfaction Following Cranial Remolding Orthosis Treatment in Infants
- ClinicalTrials.gov ID
- NCT07356401
- Acronym / sponsor ID
- cranial orthosis
- Conditions
- Plagiocephaly, Cranial Defect, Orthosis, Expectancy, Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| infant with cranial deformity | – | Device: Cranial orthosisInfants 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. |
Who may qualify
- Ages
- 3 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study includes infants aged 3-18 months with cranial deformities who have been recommended helmet therapy.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cranial orthosisThe 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. | Device | infant with cranial deformity |
Primary outcome
Change in cranial morphological measurements following cranial remolding orthosis treatment
Time frame: Periprocedural
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.
Parental treatment expectations
Time frame: baseline
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.
1 secondary outcome
Parental satisfaction
Time frame: Periprocedural
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Results publication: PubMed 30404423Lee HS, Kim SJ, Kwon JY. Parents' Perspectives and Clinical Effectiveness of Cranial-Molding Orthoses in Infants With Plagiocephaly. Ann Rehabil Med. 2018 Oct;42(5):737-747. doi: 10.5535/arm.2018.42.5.737. Epub 2018 Oct 31.
- Results publication: PubMed 18754893McGarry A, Dixon MT, Greig RJ, Hamilton DR, Sexton S, Smart H. Head shape measurement standards and cranial orthoses in the treatment of infants with deformational plagiocephaly. Dev Med Child Neurol. 2008 Aug;50(8):568-76. doi: 10.1111/j.1469-8749.2008.03017.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plagiocephaly and Cranial Defect, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in cranial morphological measurements following cranial remolding orthosis treatment (time frame: Periprocedural). The study lists 2 primary outcomes in all. 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 NCT07356401, which also lists 2 linked publications.
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 11 Sep 2026.