BridgeMD
New treatment option for Plagiocephaly, Nonsynostotic
Official title OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates
ClinicalTrials.gov ID: NCT05848895
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 4
You may be able to join if
- 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
See the full eligibility 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
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 day to 4 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.