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Cranial Orthotic Device Versus Repositioning Techniques for the Management of Plagiocephaly: the CRANIO Randomized Trial (CRANIO)

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ClinicalTrials.gov Identifier: NCT02370901
Recruitment Status : Recruiting
First Posted : February 25, 2015
Last Update Posted : November 11, 2021
Sponsor:
Collaborator:
University of South Florida
Information provided by (Responsible Party):
Pat Ricalde,DDS, MD, FACS, University of South Florida

Brief Summary:
This study evaluates the effectiveness of repositioning techniques and neck stretching exercises in comparison to cranial orthotic devices (COD) in correcting plagiocephaly in infants.

Condition or disease Intervention/treatment Phase
Plagiocephaly, Nonsynostotic Device: Helmet Behavioral: home therapies Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cranial Orthotic Device Versus Repositioning Techniques for the Management of Plagiocephaly: the CRANIO Randomized Trial
Actual Study Start Date : November 6, 2017
Estimated Primary Completion Date : November 6, 2022
Estimated Study Completion Date : November 6, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Helmet
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.
Device: Helmet
Custom fitting helmet, FDA approved, to allow reshaping of the infant skull
Other Name: Cranial Orthotic Device, Starband

Experimental: home therapies
Patients will be referred to a physical therapist. They will be offered education, neck stretching exercises, and repositioning techniques, and reassurance.
Behavioral: home therapies
parents will be instructed to do home neck stretching exercises, as well as repositioning techniques to keep baby off the flat spot. They will also be offered reassurance.
Other Name: NSE/ RPT




Primary Outcome Measures :
  1. 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) [ Time Frame: 24 months ]
    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 :
  1. Parent satisfaction [ Time Frame: 12 months ]
    questionnaire will be administered at 6, 12, 24 months

  2. Impression of skull deformity [ Time Frame: 24 months ]
    questionnaire will be administered



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Months to 7 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children diagnosed with deformational molding (CVA greater than 6mm, CI > 90%, or mixed)

Exclusion Criteria:

  • Children younger than 4 months and older than 7 months
  • Children with plagiocephaly due to craniosynostosis, neoplasm, vertebral, or hydrocephalus.
  • Scaphocephaly

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370901


Contacts
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Contact: Pat Ricalde, MD,DDS,FACS 813-870-6000 ricalde@flcranio.com

Locations
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United States, Florida
The Florida Craniofacial Institute Recruiting
Tampa, Florida, United States, 33607
Contact: Pat Ricalde, MD, DDS    813-870-6000    ricalde@flcranio.com   
Sponsors and Collaborators
Pat Ricalde,DDS, MD, FACS
University of South Florida
Investigators
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Principal Investigator: Pat Ricalde, MD,DDS,FACS Florida Craniofacial Institute
Publications of Results:
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Responsible Party: Pat Ricalde,DDS, MD, FACS, Director, Florida Craniofacial Institute, University of South Florida
ClinicalTrials.gov Identifier: NCT02370901    
Other Study ID Numbers: Plagiocephaly
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: November 11, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Plagiocephaly
Plagiocephaly, Nonsynostotic
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities