Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation
Effectiveness of Repositioning, Physical Therapy, and Cranial Remolding in Infants With Cranial Deformation
University of Texas Southwestern Medical Center
65 participants
May 23, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria1
- Healthy infants with normal physical development and no need for physical therapy intervention
Exclusion Criteria3
- Infants with abnormal head shapes (plagiocephaly or craniosynostosis)
- Infants with growth abnormalities (such as genetic conditions)
- Infants with developmental delay significant to warrant physical therapy or occupational therapy
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05917678