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Osteopathic Treatment vs Repositioning for Flat Head Syndrome (OPT-IN Trial)

N/A

Recruiting

Led By Kimberly J Wolf, DO

Research Sponsored by Osteopathy's Promise to Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

OPT-IN Trial Summary

This trial will compare OMT to standard care in kids with DP to see if OMT can improve cranial symmetry more than standard care.

Who is the study for?

This trial is for infants under 4 months old diagnosed with positional plagiocephaly, also known as flat head syndrome. It's not for those born preterm, with genetic syndromes, muscle tone disorders, craniofacial defects like cleft lip/palate, prior treatments such as helmet therapy or OMT, or other neurological issues.Check my eligibility

What is being tested?

The study compares osteopathic manipulative treatment (OMT), focusing on cranial symmetry restoration to standard care which involves repositioning by parents. Infants will first receive one treatment for 8 weeks and then switch to the other method in this crossover randomized trial.See study design

What are the potential side effects?

While specific side effects are not detailed here, OMT is generally considered a gentle intervention; however, there may be risks of discomfort during manipulation or potential delayed identification of non-deformational conditions due to reliance on manual therapies.

OPT-IN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cranial Vault Asymmetry Index

Head circumference

Weight

Secondary outcome measures

Developmental Milestones

Medical history

OPT-IN Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Osteopathic Manipulative TreatmentExperimental Treatment1 Intervention

Patients will be treated once a week with OMT x 8 weeks

Group II: Standard of Care RepositioningActive Control1 Intervention

Patients will only receive repositioning only x 8 weeks and all parents will receive standardized materials to counsel/instruct on the repositioning

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Osteopathic Manipulative Treatment

2008

Completed Phase 4

~2530

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hollis King, DOUNKNOWN

Osteopathy's Promise to ChildrenLead Sponsor

Kimberly J Wolf, DOPrincipal InvestigatorOsteopathy's Promise to Children

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the participant pool for this trial exclusive to those aged 70 or above?

"This study seeks to include individuals between 1 day old and 4 months in age."

Answered by AI

Are there any available slots for participants in this clinical experiment?

"The research is actively seeking patients, as evidenced by the information found on clinicaltrials.gov. This trial was initially posted on October 26th 2023, and the latest update occurred on October 30th 2023."

Answered by AI

How many participants are involved in this research project?

"Affirmative. According to the clinicaltrials.gov webpage, this medical study is actively recruiting volunteers starting from 26th October 2023; its most recent update was on 30th October last year with 122 patients needed for enrolment at a single site."

Answered by AI

To whom does this research trial offer enrollment eligibility?

"This experimental trial is seeking 122 infants, between day one and four months old, with positional plagiocephaly. Recruited patients must fulfill the following conditions: a diagnosis of positional plagiocephaly, preterm birth (<37 weeks), genetic syndromes, craniofacial defects/deformities (e.g. cleft lip/palate), brachycephaly/scaphocephaly, hypotonia or hypertonia , craniosynostosis; head trauma or other neurological illnesses may also prove to be relevant factors when enrolling for this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates

Kimberly Wolf 2023. "OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05848895.