Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT05917678
Status
Recruiting
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Conditions

  • Brachycephaly
  • Congenital Muscular Torticollis
  • Deformational Plagiocephaly
  • Deformational Posterior Plagiocephaly
  • Torticollis

Eligibility Criteria

Sex
ALL
Age
2 Months - 3 Months
Healthy Volunteers
Accepted

Interventions

  • Repositioning Therapy — OTHER
    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.
  • Cranial Remolding Orthosis — DEVICE
    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.

Study Details

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.

Key Dates

Start date
May 23, 2023
Status verified
Aug 2025
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
65 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Final Head Shape [ Time Frame: 10 months after enrollment (at 12 months of age) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390
Tiffany Graham, MSPO
[email protected]
214-645-8250
Rami Hallac, PhD (SUB_INVESTIGATOR)
Jijia Wang, PhD (SUB_INVESTIGATOR)
Alex Kane, MD (SUB_INVESTIGATOR)
Caitlin Deville, DSc (SUB_INVESTIGATOR)
Susan Simpkins, EdD (SUB_INVESTIGATOR)

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By research site
University of Texas Southwestern Medical Center· Dallas, TX

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