Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation

NARecruitingINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

May 23, 2023

Primary Completion Date

July 1, 2026

Study Completion Date

July 1, 2026

Conditions
Deformational PlagiocephalyDeformational Posterior PlagiocephalyBrachycephalyTorticollisCongenital Muscular Torticollis
Interventions
OTHER

Repositioning Therapy

Caregivers will be instructed how to increase tummy time activities and reshape their infant's heads using at-home methods to direct their attention to the non-preferred side.

DEVICE

Cranial Remolding Orthosis

A custom cranial remolding orthosis (FDA Class II device) will be made to fit affected infants. this should be worn 23 hours per day and the Orthotist needs to be seen regularly for adjustments until the head shape is resolved.

Trial Locations (1)

75390

RECRUITING

University of Texas Southwestern Medical Center, Dallas

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Children's Health

OTHER

lead

University of Texas Southwestern Medical Center

OTHER