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RECRUITING
NCT05917678
NA

Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation

Sponsor: University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

Summary

This study will examine how effective caregiver's repositioning strategies are in correcting an infant's deformational cranial shape, as well as the effectiveness of the use of a custom cranial remolding orthosis for treatment of deformational head shapes. Infants with torticollis will be concurrently enrolled in physical therapy treatment until the torticollis is resolved. A normal, unaffected population will be studied to compare typical growth to the growth of infants undergoing active treatment.

Official title: Effectiveness of Repositioning, Physical Therapy, and Cranial Remolding in Infants With Cranial Deformation

Key Details

Gender

All

Age Range

2 Months - 3 Months

Study Type

INTERVENTIONAL

Enrollment

65

Start Date

2023-05-23

Completion Date

2026-07-01

Last Updated

2025-08-28

Healthy Volunteers

Yes

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.

Locations (1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States