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Cranial Orthotic Device

home therapies for Flat Head Syndrome (CRANIO Trial)

N/A
Waitlist Available
Led By Pat Ricalde, MD,DDS,FACS
Research Sponsored by pricalde
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children diagnosed with deformational molding (CVA greater than 6mm, CI > 90%, or mixed)
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

CRANIO Trial Summary

This trial found that repositioning techniques and neck exercises are more effective than CODs in correcting plagiocephaly in infants.

Eligible Conditions
  • Flat Head Syndrome

CRANIO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

CRANIO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effectiveness of helmet versus repositioning techniques for treatment of deformational molding (CVA must be less than or equal to (x-5)/2 and/or CI must be less than or equal to (x-89)/2)
Secondary outcome measures
Impression of skull deformity
Parent satisfaction

CRANIO Trial Design

2Treatment groups
Experimental Treatment
Group I: home therapiesExperimental Treatment1 Intervention
Patients will be referred to a physical therapist. They will be offered education, neck stretching exercises, and repositioning techniques, and reassurance.
Group II: HelmetExperimental Treatment1 Intervention
Patients will be referred to a cranial orthotist who will create a custom cranial orthotic device. They will undergo adjustments monthly. At these appointments anthropometric measurements will be done by the cranial orthotist. The orthotist will be blinded and will not be informed of which patient is involved in the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Helmet
2010
N/A
~260

Find a Location

Who is running the clinical trial?

pricaldeLead Sponsor
University of South FloridaOTHER
412 Previous Clinical Trials
186,833 Total Patients Enrolled
Pat Ricalde,DDS, MD, FACSLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
TrialsJournal
Helmet Therapy Assessment in Infants with Deformed Skulls (HEADS): Protocol for a Randomised Controlled Trial
van Wijk, Renske M, Magda M Boere-Boonekamp, Catharina GM Groothuis-Oudshoorn, Leo A van Vlimmeren, and Maarten J IJzerman. 2012. “Helmet Therapy Assessment in Infants with Deformed Skulls (HEADS): Protocol for a Randomised Controlled Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/1745-6215-13-108.
clinicaltrials.govStudy
Cranial Orthotic Device Versus Repositioning Techniques for the Management of Plagiocephaly: the CRANIO Randomized Trial
Pat Ricalde,DDS, MD, FACS 2017. "Cranial Orthotic Device Versus Repositioning Techniques for the Management of Plagiocephaly: the CRANIO Randomized Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02370901.
~30 spots leftby Apr 2025
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