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Идёт набор NCT07356401

Associations of Cranial Outcomes and Parental Expectations and Satisfaction

— Наблюдательное Plagiocephaly Cranial Defect Orthosis Expectancy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Cranial orthosis.
Кому может быть актуально
Состояния в реестре: Plagiocephaly, Cranial Defect, Orthosis, Expectancy. Базовые параметры: 3 мес. — 18 мес. · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Устройство Cranial orthosis
    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 ortho

Первичные конечные точки

  • Change in cranial morphological measurements following cranial remolding orthosis treatment [Срок оценки: Periprocedural]
  • Parental treatment expectations [Срок оценки: baseline]
Вторичные конечные точки (1)
  • Parental satisfaction [Срок оценки: Periprocedural]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • University of Health Sciences Gülhane Faculty of Health Sciences — Ankara

Публикации

  • 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
  • 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

Идентификаторы

NCT: NCT07356401 · cranial orthosis

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗