Associations of Cranial Outcomes and Parental Expectations and Satisfaction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-18
SponsorGulhane School of Medicine
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
This trial does not accept healthy volunteersQualifiers
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 population
The study includes infants aged 3-18 months with cranial deformities who have been recommended helmet therapy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cranial orthosis
DeviceThe 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: infant with cranial deformity1 intervention
Trial outcomes
Primary outcomes
1
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
Periprocedural2
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
baselineSecondary 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.
Time frame
PeriproceduralSponsors and contacts
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Source ClinicalTrials.gov