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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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 Summary:

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
Sponsor: pricalde

Current 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) [ 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Parent satisfaction [ Time Frame: 12 months ]
    questionnaire will be administered at 6, 12, 24 months
  • Impression of skull deformity [ Time Frame: 24 months ]
    questionnaire will be administered


Original Secondary Outcome: Same as current

Information By: University of South Florida

Dates:
Date Received: February 5, 2015
Date Started: July 2017
Date Completion: January 2020
Last Updated: January 6, 2017
Last Verified: January 2017