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Association Between Cranial Morphological Changes, Parental Expectations, and Satisfaction Following Cranial Remolding Orthosis Treatment in Infants

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 1
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
University of Health Sciences Gülhane Faculty of Health Sciences
RECRUITING
Ankara
Contact Information
Primary
Güllü AYDIN YAĞCIOĞLU, Asst. Prof
gulluaydin23@gmail.com
+905536140823
Time Frame
Start Date: 2025-11-25
Estimated Completion Date: 2026-03-15
Participants
Target number of participants: 20
Treatments
infant with cranial deformity
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.
Related Therapeutic Areas
Sponsors
Leads: Gulhane School of Medicine

This content was sourced from clinicaltrials.gov

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