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Actively Recruiting

Age: 3Months - 18Months
All Genders
ID07356401

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

Led by Gulhane School of Medicine · Updated on 2026-01-26

20

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to study the relationship between changes in head shape and the expectations and satisfaction of parents whose infants are treated with a cranial remolding orthosis CRO. It focuses on infants diagnosed with positional cranial deformities such as plagiocephaly or brachycephaly. The study will assess objective head shape changes before and after treatment and how these relate to parental views collected through specific questionnaires. Infants will receive a custom-made cranial remolding orthosis, designed using 3D scanning and computer modeling to fit each infants unique head shape. The orthosis is carefully fitted and checked for comfort and skin safety. Parents will be given instructions on care, and infants will attend regular clinic visits during the treatment and follow-up period. Participants will be involved in providing cranial measurements before and after treatment and completing questionnaires about their expectations and satisfaction. Researchers will analyze changes in head shape alongside parental feedback. The study includes close clinical monitoring and aims to better understand how objective outcomes align with family experiences during CRO therapy. Participation lasts through the full treatment and follow-up timeframe.

CONDITIONS

Brief Title

Associations of Cranial Outcomes and Parental Expectations and Satisfaction

Who Can Participate

Age: 3Months - 18Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants diagnosed with positional cranial deformities such as plagiocephaly, brachycephaly, or asymmetrical head shape
  • Infants who received treatment with a custom-made cranial remolding orthosis
  • Availability of cranial measurements before and after treatment
  • Parents or legal guardians provided consent and completed expectation and satisfaction questionnaires
  • Infants who completed the planned treatment and follow-up period
Not Eligible

You will not qualify if you...

  • Infants with neurological disorders, genetic syndromes, or congenital conditions affecting head growth
  • Infants who had previous cranial surgery or other cranial interventions
  • Infants who received non-custom-made or prefabricated cranial orthoses
  • Incomplete clinical records or missing cranial measurements
  • Parents or caregivers unable to complete questionnaires due to language or cognitive limitations
  • Infants diagnosed with microcephaly or macrocephaly

Research Team

G

Güllü AYDIN YAĞCIOĞLU, Asst. Prof

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