Parents' Perspectives and Clinical Effectiveness of Cranial-Molding Orthoses in Infants With Plagiocephaly.
Hyo Sun Lee, Sang Jun Kim, Jeong-Yi Kwon
https://pubmed.ncbi.nlm.nih.gov/30404423Actively 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 infant's 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
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Varies based on individual treatment plan
Participants are fitted with a custom-made cranial remolding orthosis designed specifically for their cranial shape. During the initial fitting, the orthosis is checked for proper fit and any skin issues, with instructions provided to parents on use and care.
1 initial fitting visit (in-person)
Post-operative Follow-up
Duration - Duration of orthosis treatment until planned treatment completion
Participants attend regular clinical follow-up visits to monitor cranial morphological changes and parental satisfaction during the course of orthosis treatment.
Regular follow-up visits throughout treatment period
Trial Site Locations
Total: 1 location
1
University of Health Sciences Gülhane Faculty of Health Sciences
Ankara, Keçiören, Turkey (Türkiye), 06010
Actively Recruiting
Loading map...
Research Team
G
Güllü AYDIN YAĞCIOĞLU, Asst. Prof
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Head shape measurement standards and cranial orthoses in the treatment of infants with deformational plagiocephaly.
Anthony McGarry, Melville T Dixon, Robert J Greig...
https://pubmed.ncbi.nlm.nih.gov/18754893