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

2015-03-11 02:08:22 | BioPortfolio

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.

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Conditions

Plagiocephaly

Intervention

Helmet, home therapies

Status

Not yet recruiting

Source

University of South Florida

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-03-11T02:08:22-0400

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Medical and Biotech [MESH] Definitions

The condition characterized by uneven or irregular shape of the head often in parallelogram shape with a flat spot on the back or one side of the head. It can either result from the premature CRANIAL SUTURE closure (CRANIOSYNOSTOSIS) or from external forces (NONSYNOSTOTIC PLAGIOCEPHALY).

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Public or private organizations that provide, either directly or through arrangements with other organizations, home health services in the patient's home. (Hospital Administration Terminology, 2d ed)

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