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

NCT02370901 | Unknown FDA Device

• 1 other identifier: Plagiocephaly
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

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.

Conditions

Plagiocephaly, Nonsynostotic

Outcome Measures

Primary Outcomes (1)

• 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)

  CVA must be less than or equal to (x-5)/2 and/or CI must be less than or equal to (x-89)/2

  24 months

Secondary Outcomes (2)

• Parent satisfaction

  12 months

• Impression of skull deformity

  24 months

Study Arms (2)

Helmet

EXPERIMENTAL

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

home therapies

EXPERIMENTAL

Patients will be referred to a physical therapist. They will be offered education, neck stretching exercises, and repositioning techniques, and reassurance.

Behavioral: home therapies

Interventions

Helmet DEVICE

Custom fitting helmet, FDA approved, to allow reshaping of the infant skull

Also known as: Cranial Orthotic Device, Starband

Helmet

home therapies BEHAVIORAL

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.

Also known as: NSE/ RPT

home therapies

Eligibility Criteria

• Age: 4 Months - 7 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children diagnosed with deformational molding (CVA greater than 6mm, CI \> 90%, or mixed)

You may not qualify if:

• Children younger than 4 months and older than 7 months
• Children with plagiocephaly due to craniosynostosis, neoplasm, vertebral, or hydrocephalus.
• Scaphocephaly

Sponsors & Collaborators

• Pat Ricalde,DDS, MD, FACS: lead
• University of South Florida: collaborator

Study Sites (1)

The Florida Craniofacial Institute

Tampa, Florida, 33607, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 22776627 RESULT

MeSH Terms

Conditions

Plagiocephaly, Nonsynostotic

Interventions

Head Protective Devices; Home Infusion Therapy

Condition Hierarchy (Ancestors)

Plagiocephaly; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture; Drug Therapy; Therapeutics; Home Care Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Pat Ricalde, MD,DDS,FACS

  Florida Craniofacial Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pat Ricalde, MD,DDS,FACS

CONTACT

813-870-6000; ricalde@flcranio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Florida Craniofacial Institute

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: February 25, 2015
• Study Start: November 6, 2017
• Primary Completion: November 6, 2022
• Study Completion: November 6, 2022
• Last Updated: November 11, 2021

Record last verified: 2021-11

Locations

US (1)