Associations of Cranial Outcomes and Parental Expectations and Satisfaction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cranial orthosis.
- Who it may be relevant to
- Registry conditions: Plagiocephaly, Cranial Defect, Orthosis, Expectancy. Basic parameters: 3 months — 18 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Association Between Cranial Morphological Changes, Parental Expectations, and Satisfaction Following Cranial Remolding Orthosis Treatment in Infants
Overview
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.
Interventions
- 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 ortho
Primary outcome measures
- Change in cranial morphological measurements following cranial remolding orthosis treatment [Time frame: Periprocedural]
- Parental treatment expectations [Time frame: baseline]
Secondary outcome measures (1)
- Parental satisfaction [Time frame: Periprocedural]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- University of Health Sciences Gülhane Faculty of Health Sciences — Ankara
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. PMID 30404423
- McGarry 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. PMID 18754893
Identifiers
NCT: NCT07356401 · cranial orthosis