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

NCT02370901 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2021-11-11

No results posted yet for this study

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

Interventions

DEVICE

Helmet

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

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.

Sponsors & Collaborators

  • University of South Florida

    collaborator OTHER

  • Pat Ricalde,DDS, MD, FACS

    lead OTHER

Principal Investigators

  • Pat Ricalde, MD,DDS,FACS · Florida Craniofacial Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
7 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-06
Primary Completion
2022-11-06
Completion
2022-11-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02370901 on ClinicalTrials.gov