Effectiveness of Repositioning, Physical Therapy, and Cranial Remolding in Infants With Cranial Deformation
Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 2 months
Maximum Age: 3 months
Healthy Volunteers: t
View:
• Healthy infants with normal physical development and no need for physical therapy intervention
Locations
United States
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Tiffany Graham, MSPO
Tiffany.Graham@utsouthwestern.edu
214-645-8250
Time Frame
Start Date: 2023-05-23
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 65
Treatments
Other: Repositioning Therapy
Infants will be treated with at-home repositioning strategies for their deformational head shape. Physical therapy will be provided, if indicated, for treatment of torticollis. This is a standard treatment.
Other: Repositioning Therapy + Cranial Remolding Orthoses
After attempting at 2-4 months of repositioning therapy, infants with residual cranial deformation may be treated with a custom made helmet (cranial remolding orthosis) which is adjusted every few weeks to direct skull growth. It is worn 23 hours per day. Physical therapy will be provided, if indicated, for treatment of torticollis. This is a standard treatment.
No_intervention: Control
Healthy infants without deformational head shapes or need for physical therapy will be followed and measured. No intervention.
Related Therapeutic Areas
Sponsors
Leads: University of Texas Southwestern Medical Center
Collaborators: Children's Health