Recruiting

Cranial Orthotic Device vs. Repositioning Techniques

Sponsor:

Pat Ricalde,DDS, MD, FACS

Code:

NCT02370901

Conditions

Plagiocephaly, Nonsynostotic

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

Helmet

home therapies

Study Details

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

Study ID

NCT02370901

Start date

Nov 6, 2017

Status verified date

Nov, 2021

Completion date

Nov 6, 2022

Anticipated

Primary completion date

Nov 6, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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

Study Design

Enrollment

226 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

experimental: home therapies

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

Interventions

Helmet

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

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Pat Ricalde, MD,DDS,FACS

813-870-6000ricalde@flcranio.com

Locations

The Florida Craniofacial Institute

Recruiting

Tampa, Florida, United States, 33607

Contacts

Pat Ricalde, MD, DDS

813-870-6000ricalde@flcranio.com

More Information

Sponsor

Pat Ricalde,DDS, MD, FACS

Last update posted

Nov 11, 2021

Last verified

Nov, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pat Ricalde,DDS, MD, FACS on 2021-11-11.