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

Brief Title

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

Official Title

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

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.
    

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.
    


Study Type

Interventional


Primary Outcome

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

 Parent satisfaction

Condition

Plagiocephaly

Intervention

Helmet

Study Arms / Comparison Groups

 Helmet
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

226

Start Date

November 6, 2017

Completion Date

November 6, 2020

Primary Completion Date

November 6, 2019

Eligibility 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
      

Gender

All

Ages

4 Months - 7 Months

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 



Administrative Informations


NCT ID

NCT02370901

Organization ID

Plagiocephaly


Responsible Party

Sponsor-Investigator

Study Sponsor

pricalde

Collaborators

 University of South Florida

Study Sponsor

, , 


Verification Date

October 2017