Cranial Defect, Expectancy, Orthosis, Plagiocephaly, Satisfaction
Conditions
Brief 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. 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
DEVICECranial 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.
Sponsors
Gulhane School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Months to 18 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cranial morphological measurements following cranial remolding orthosis treatment | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parental satisfaction | Periprocedural | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed