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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Plagiocephaly, Nonsynostotic | Device: Helmet Behavioral: home therapies | Not Applicable |

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 |

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 |
- 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

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

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
Contact: Pat Ricalde, MD,DDS,FACS | 813-870-6000 | ricalde@flcranio.com |
United States, Florida | |
The Florida Craniofacial Institute | Recruiting |
Tampa, Florida, United States, 33607 | |
Contact: Pat Ricalde, MD, DDS 813-870-6000 ricalde@flcranio.com |
Principal Investigator: | Pat Ricalde, MD,DDS,FACS | Florida Craniofacial Institute |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Plagiocephaly Plagiocephaly, Nonsynostotic Craniofacial Abnormalities |
Musculoskeletal Abnormalities Musculoskeletal Diseases Congenital Abnormalities |