An interventional study of Osteopathic Manipulative Treatment and Standard of Care Repositioning in Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional and Plagiocephaly, sponsored by Osteopathy's Promise to Children. Recruiting at 1 site in United States. Open to participants aged 1 Day to 4 Months. Per ClinicalTrials.gov, last updated 2025-08-03.
Sponsored by Osteopathy's Promise to Children · Not applicable, Interventional, and Treatment
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:
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.
16 studies on the registry are indexed under Plagiocephaly; 4 are open to participants now.
Browse Plagiocephaly studies →This is the only study on the registry with Osteopathy's Promise to Children as lead sponsor.
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Exclusions:
Patients will be treated once a week with OMT x 8 weeks
Procedure: Osteopathic Manipulative Treatment
Patients will only receive repositioning only x 8 weeks and all parents will receive standardized materials to counsel/instruct on the repositioning
Behavioral: Standard of Care Repositioning
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.
Parents will receive standardized handouts/materials instructing on repositioning intended to help improve head shape in infants with plagiocephaly.
Cranial Vault Asymmetry Index
Anthropometric measurement of cranial asymmetry
Time frame: 2 years
Head circumference
Standard growth parameter measured in infants
Time frame: 2 years
Weight
Standard growth parameter measured in infants
Time frame: 2 years
Medical history
Patients charts will be reviewed after first year of life to assess for medical issues including otitis media, developmental delay, allergic rhinitis, vision problems, torticollis, hospitalizations, need for a helmet to treat plagiocephaly, colic, reflux/GER, etc.
Time frame: 12 months
Developmental Milestones
Patients' enrolled in the study will have developmental stones monitored as per general pediatrician's protocol to screen for developmental delays.
Time frame: 12 months
Plan to share: No
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