About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Cranial orthosis