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NCT Number: NCT07356401

Associations of Cranial Outcomes and Parental Expectations and Satisfaction

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.

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Key information

Conditions

Plagiocephaly Behavior Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cranial Defect Craniofacial Abnormalities Expectancy Musculoskeletal Abnormalities Musculoskeletal Diseases Orthosis Personal Satisfaction Satisfaction

Age range

3 month–18 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Health Sciences Gülhane Faculty of Health Sciences

Ankara, Keçiören, 06010, Turkey (Türkiye)

Location status: Recruiting

Location contact

Güllü Yağcıoğlu

CONTACT

[email protected]

05536140823

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in cranial morphological measurements following cranial remolding orthosis treatment

    Time frame: Periprocedural

    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.

  2. Parental treatment expectations

    Time frame: baseline

    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.

Secondary outcomes

  1. Parental satisfaction

    Time frame: Periprocedural

    Parental satisfaction with cranial remolding orthosis treatment is assessed after completion of the treatment period using the Quebec User Evaluation of Satisfaction with Assistive Technology. This measure evaluates satisfaction with the cranial remolding orthosis in terms of device-related characteristics and overall satisfaction with the assistive technology.

Study contacts

Contact information is provided by the study sponsor or research team.

Güllü AYDIN YAĞCIOĞLU, Asst. Prof

CONTACT

[email protected]

+905536140823

Sponsors and collaborators

Lead sponsor

Gulhane School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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