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 : 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
|Condition or disease||Intervention/treatment||Phase|
|Plagiocephaly||Device: Helmet Behavioral: home therapies||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||226 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
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
- 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
- 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