Associations of Cranial Outcomes and Parental Expectations and Satisfaction

NCT07356401 | Recruiting

• 1 other identifier: cranial orthosis
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Orthosis; Plagiocephaly; Cranial Defect; Expectancy; Satisfaction

Outcome Measures

Primary Outcomes (2)

• 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.

  Periprocedural

• 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.

  baseline

Secondary Outcomes (1)

• Parental satisfaction

  Periprocedural

Study Arms (1)

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.

Device: Cranial orthosis

Interventions

Cranial orthosis DEVICE

The 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.

infant with cranial deformity

Eligibility Criteria

• Age: 3 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study includes infants aged 3-18 months with cranial deformities who have been recommended helmet therapy.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gulhane School of Medicine: lead

Study Sites (1)

University of Health Sciences Gülhane Faculty of Health Sciences

Ankara, Keçiören, 06010, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Lee HS, Kim SJ, Kwon JY. Parents' Perspectives and Clinical Effectiveness of Cranial-Molding Orthoses in Infants With Plagiocephaly. Ann Rehabil Med. 2018 Oct;42(5):737-747. doi: 10.5535/arm.2018.42.5.737. Epub 2018 Oct 31.

  PMID: 30404423 RESULT

• McGarry A, Dixon MT, Greig RJ, Hamilton DR, Sexton S, Smart H. Head shape measurement standards and cranial orthoses in the treatment of infants with deformational plagiocephaly. Dev Med Child Neurol. 2008 Aug;50(8):568-76. doi: 10.1111/j.1469-8749.2008.03017.x.

  PMID: 18754893 RESULT

MeSH Terms

Conditions

Plagiocephaly; Personal Satisfaction

Condition Hierarchy (Ancestors)

Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Central Study Contacts

Güllü AYDIN YAĞCIOĞLU, Asst. Prof

CONTACT

+905536140823; gulluaydin23@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 21, 2026
• Study Start: November 25, 2025
• Primary Completion: February 15, 2026
• Study Completion: March 15, 2026
• Last Updated: January 26, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)