OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates

Обзор

The goal of this crossover randomized clinical trial is to assess the effects of osteopathic manipulative treatment (OMT) compared to standard of care repositioning in children diagnosed with positional/deformational plagiocephaly. The main hypothesis is that children who received OMT will show significantly improved anthropometric measures of cranial symmetry over those receiving the current pediatric standard of care of repositioning. This is a two-arm, randomized cross-over clinical trial. With parental consent, pediatric patients (infants \<4 months of age) will be organized into one of two groups: 1. Those who receive OMT with emphasis on osteopathic cranial manipulative medicine (OCMM) to restore cranial symmetry. 2. Those who receive standard care only with repositioning attention from the parents After 8-weeks of being in the first group, each participant will cross-over into the second group (OMT or repositioning) N = 122 subjects diagnosed with deformational plagiocephaly (DP) are to be recruited (to allow for natural attrition and loss to follow up) with the recruitment to continue until 61 patients have been placed in each of the two groups and will cross-over to the respective treatment group (OMT and standard of care repositioning therapy). Timeline: It is projected that to recruit and carry out the assessments and interventions (8-weeks of each group with 12-months of follow-up longitudinally), it will require two years (24-months) from the beginning of the study to completion.

Вмешательства

• Процедура Osteopathic Manipulative Treatment
  Osteopathic Manipulative Treatment is a manual treatment therapy applied by licensed physicians that consists of using ones hands to improve the structure and function of the body. In this situation it will involve gentle and passive modalities that are well-tolerated by infants.
• Поведенческое Standard of Care Repositioning
  Parents will receive standardized handouts/materials instructing on repositioning intended to help improve head shape in infants with plagiocephaly.

Первичные конечные точки

• Cranial Vault Asymmetry Index [Срок оценки: 2 years]
• Head circumference [Срок оценки: 2 years]
• Weight [Срок оценки: 2 years]

Вторичные конечные точки (2)

• Medical history [Срок оценки: 12 months]
• Developmental Milestones [Срок оценки: 12 months]

Критерии участия

Inclusions:

• Diagnosed with positional plagiocephaly
• Under 4-months of age (between birth - 4 months) at the time of enrollment

Exclusions:

• Preterm birth (<37 weeks)
• Genetic syndromes
• Craniofacial defects/deformities (e.g. cleft lip/palate)
• Brachycephaly/scaphocephaly
• Hypotonia
• Hypertonia
• Craniosynostosis
• Head trauma or other neurological illnesses
• Lost to follow up
• Patient whose parents (or legal guardians) disagree to attend 8-treatments of OMT and 2 additional measurement sessions
• Prior helmet therapy, physical therapy, or OMT before the date of enrollment

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Osteopathic Center San Diego — San Diego

Идентификаторы

NCT: NCT05848895 · OPC001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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