Associations of Cranial Outcomes and Parental Expectations and Satisfaction

Gulhane School of Medicine

Status: Enrolling

Conditions: Orthosis; Plagiocephaly; Cranial Defect; Satisfaction; Expectancy

Treatments: Device: Cranial orthosis

Study type: Observational

Funder types: Other

Identifiers

NCT07356401

cranial orthosis

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 3 to 18 months old

Volunteers: No Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

infant with cranial deformity

Description:

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.

Treatment:

Device: Cranial orthosis