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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02370901

Recruitment Status : Recruiting

First Posted : February 25, 2015

Last Update Posted : November 11, 2021

See Contacts and Locations

Sponsor:

Collaborator:

University of South Florida

Information provided by (Responsible Party):

Pat Ricalde,DDS, MD, FACS, University of South Florida

Study Description

Brief Summary:

This study evaluates the effectiveness of repositioning techniques and neck stretching exercises in comparison to cranial orthotic devices (COD) in correcting plagiocephaly in infants.

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

Show detailed description

Detailed Description:

This is a prospective randomized controlled trial with the goal of recruiting 226 participants. The participants will be between the ages of 4-7 months and will be randomized into two groups: Treatment group A, which will provide treatment using cranial orthotic devices (CODs) ; and Treatment group B, which will provide treatment using repositional techniques and neck stretching exercises. These participants will be offered enrollment if they have deformational molding with CVA greater than 6 mm and/or CI> 90%.

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%. Currently, repositioning exercises and helmeting therapy are both options given to the parents as there is no consensus on preferred standard of care. Once the parents have made the decision, the study investigators will monitor the patient and change therapy if there is no response to treatment or if the parents decide they would like to change therapies.

The randomization will be conducted by using a system created by the USF Department of Biostatistics. It involves a covariate adaptive randomization so that the patients will continue to be randomized throughout the trial but still allowing for covariates. Covariates for this study will be :

type of deformity - Isolated plagiocephaly (CVA >6; 75 < CI < 90), isolated brachycephaly (CVA<6; CI > 90), and mixed brachy/ plagiocephaly (CVA > 6; CI > 90)
severity of deformity - a CVA of 10 mm would be compared to another CVA of 10mm

Once families consent for their child to be a participant, basic demographic information will be collected. Study investigators will also collect data on developmental delay. Participants will be randomized by the physician to ensure appropriate grouping into each of the above mentioned covariates. The participants'' families will subsequently be notified the same day of the results of randomization into Treatment Group A or Treatment Group B. Both treatments are currently equally used in plagiocephaly, so there is no harm to the patient in being selected for one group versus another. The physician will re-evaluate the patients at 3 months, and if no progress is made , or if the parents are unhappy with the randomized form of treatment, the parents will have the option of switching to another group.

Potential adverse outcomes of the treatments themselves are listed as follows:

Treatment Group A (Cranial Orthotic Devices): Skin irritation due to helmeting

Treatment Group B: Pain caused by inappropriate technique in exercises

Study consent forms will include these and any other potential adverse outcomes, with a direct line to our office for notification. Benefits include correction of the plagiocephaly, and will be explained to the parents as the goal of treatment. All adverse outcomes will be reported to the IRB. Of note, these outcomes have yet to be witnessed by our staff despite years of treating patients with these methods.

Once randomized and selected, Treatment Group A will be fitted for CODs and will undergo monthly adjustments by a licensed cranial orthotist at West Coast Brace and Limb. This is standard of care for plagiocephaly. Monitoring of the patient's use of the helmet will be the responsibility of the parents, with goal of treatment to be 23 hours per day. The orthotist will have no knowledge of whether patients are enrolled in the study versus not, and will be conducting the normal responsibilities for their job. Data that is collected will be the same for all patients regardless of study enrollment. The principal study investigator, Dr. Ricalde, will be the only person with knowledge and access to the data collection for study patients during these visits.

Treatment Group B will be asked appropriate questionnaires by FCI staff and be encouraged to perform at-home repositioning techniques and neck stretching exercises. If the patient has any concerns they will be asked to come in for evaluation by a licensed physical therapist. This is the standard of care for plagiocephaly. The physical therapist will have no knowledge of whether patients are enrolled in the study versus not, and will be conducting the normal responsibilities for their job. Data that is collected will be the same for all patients regardless of study enrollment. Dr. Ricalde will be the only person with knowledge and access to the data collection for study patients during these visits.

The physical therapist and the orthotist will both be blinded to study participants, but true blinding of the treatment is not possible as the treatments require some knowledge by the parents. Initially, data will include a health questionnaire to screen for sex and developmental delay , as well as having initial CVA and CI measurements via STAR Scanner device, a standard device used by orthotists using laser light that has no harmful effects to the patient. In addition to initial measurements, patients will have measurements taken monthly (CVA and CI) by the cranial orthotist. All patients will receive photos, Star Scanner measurements, and questionnaires A and C at 6, 12, 24 months to evaluate treatment progression. Questionnaires will be administered to parents to assess satisfaction at 6, 12, 24 months. The option to switch treatment will be conducted at 3 months.

Study Design

Layout table for study information

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
Actual Study Start Date :	November 6, 2017
Estimated Primary Completion Date :	November 6, 2022
Estimated Study Completion Date :	November 6, 2022

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Plagiocephaly

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 :

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

Eligibility Criteria

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.

Layout table for eligibility information

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

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370901

Contacts

Layout table for location contacts

Contact: Pat Ricalde, MD,DDS,FACS	813-870-6000	ricalde@flcranio.com

Locations

Layout table for location information

United States, Florida
The Florida Craniofacial Institute	Recruiting
Tampa, Florida, United States, 33607
Contact: Pat Ricalde, MD, DDS 813-870-6000 ricalde@flcranio.com

Sponsors and Collaborators

Pat Ricalde,DDS, MD, FACS

University of South Florida

Investigators

Layout table for investigator information

Principal Investigator:	Pat Ricalde, MD,DDS,FACS	Florida Craniofacial Institute

More Information

Publications of Results:

van Wijk RM, Boere-Boonekamp MM, Groothuis-Oudshoorn CG, van Vlimmeren LA, IJzerman MJ. HElmet therapy Assessment in infants with Deformed Skulls (HEADS): protocol for a randomised controlled trial. Trials. 2012 Jul 9;13:108. doi: 10.1186/1745-6215-13-108.

Layout table for additonal information

Responsible Party:	Pat Ricalde,DDS, MD, FACS, Director, Florida Craniofacial Institute, University of South Florida
ClinicalTrials.gov Identifier:	NCT02370901
Other Study ID Numbers:	Plagiocephaly
First Posted:	February 25, 2015 Key Record Dates
Last Update Posted:	November 11, 2021
Last Verified:	November 2021

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	Yes

Additional relevant MeSH terms:

Layout table for MeSH terms

Plagiocephaly Plagiocephaly, Nonsynostotic Craniofacial Abnormalities	Musculoskeletal Abnormalities Musculoskeletal Diseases Congenital Abnormalities

To Top