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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02370901
Recruitment Status : Unknown
Verified October 2017 by pricalde, University of South Florida.
Recruitment status was:  Not yet recruiting
First Posted : February 25, 2015
Last Update Posted : November 1, 2017
University of South Florida
Information provided by (Responsible Party):
pricalde, University of South Florida

Brief Summary:
Babies 4-7 months of age with positional plagiocephaly will be treated with repositional techniques verse helmet therapy. The helmet therapy children will be fitted a helmet at Westcoast Brace and Limb and monitored during treatment to ensure proper fitting of helmet. The repositioning children's parents will given instructions on how to perform neck stretching exercises and repositioning techniques and monitored during treatment. The anthropometric measurements will be done by licensed orthotist at monthly intervals for a total of six months of treatment. Before treatment, 6 months, 12 months, and 24 months from treatment all of the children will be scanned by Star Scanner (Orthomerica) to provide objective measurement of the cranial vault asymmetry and index.

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

Detailed Description:

This is a two armed prospective randomized controlled study deformational plagiocephaly patients who will be treated with orthotic helmet vs. repositional therapy. The patients in the study will be further subdivided into 3 groups: Isolated plagiocephaly (CVA >6; 75 < CI < 90), isolated brachycephaly (CVA<6; CI > 90), and mixed brachy/ plagiocephaly (CVA > 6; CI > 90). Both two armed groups will include patients with mild, moderate, and severe plagiocephaly. Randomization will be completed by a blinded third party biostatistician.

Asymmetric plagiocephaly is defined by cranial vault index (CVA). CVA is the difference between two diagonal cranial diameters (CVA= Longer diagonal-shorter diagonal). Cranial diameters are measured from orbitale superius suture to orbitale superius rear (see Appendix 1). Normal CVA is <6mm, mild CVA is 6-10mm, moderate CVA is 11-15mm, and severe CVA is >15mm. Brachycephaly is defined by the cephalic index (CI). This measurement is the width/length of cranium x100. Length of cranium is measured from glabella to opisthocranion and width is measured from eurion to eurion. Normal CI is 75-90%, mild brachycephaly is 90.1-95%, moderate brachycephaly is 95.1-100%, severe brachycephaly is >100%.

The principal investigator will recruit from patients seen at the Florida Craniofacial Institute in Tampa, Florida. If the parent expresses interest in participating in this study, and meet the criteria, they will be enrolled. During that time, the purpose and procedures as well as the details, risks, and expectations from the study will be explained. At this time, parents will also have an opportunity to ask any questions they may have regarding the experimental procedures, data collection, confidentiality, their rights as a patient, and any other questions they may have. They will be informed that their decision to either participate or not participate in the study will not affect their therapy. Treatment will begin after the parent signs a written informed consent form. During the study, data will be collected from general in-take forms by staff seeing the patients and from patient questionnaire.

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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
Estimated Study Start Date : November 6, 2017
Estimated Primary Completion Date : November 6, 2019
Estimated Study Completion Date : November 6, 2020

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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
Publications of Results:
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Responsible Party: pricalde, Director, Florida Craniofacial Institute, University of South Florida Identifier: NCT02370901    
Other Study ID Numbers: Plagiocephaly
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017

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