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RECRUITINGNANCT05848895

OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates

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 position...

Lead sponsor: Osteopathy's Promise to Children•1 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Kimberly J Wolf, DO

CONTACT

619-583-7611 kimberly.wolf@the-promise.org

Jessica Martone, PhD, MSW

CONTACT

619-693-6303 jessica.martone@the-promise.org

Sponsors

Lead Sponsor

Osteopathy's Promise to Children

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 3, 2025Terms

Trial snapshot

StatusRECRUITING

PhaseNA

Enrollment122

Start dateOct 2023

Last updatedAug 3, 2025

Condition

Plagiocephaly, Nonsynostotic Plagiocephaly, Positional Plagiocephaly Cranium; Deformity

Locations shown

Osteopathic Center San Diego

San Diego, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 3, 2025Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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