Clinical trial NCT05917678: Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation
Official title: Effectiveness of Repositioning, Physical Therapy, and Cranial Remolding in Infants With Cranial Deformation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deformational Plagiocephaly
Deformational Posterior Plagiocephaly
Brachycephaly
Torticollis
Congenital Muscular Torticollis
Keywords: plagiocephaly
brachycephaly
asymmetrical brachycephaly
helmet
cranial remolding
orthosis
repositioning
deformational
torticollis
normal
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Children's Health
First posted: 2023-06-26
Enrollment: 65
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Infants with deformational head shapes start with repositioning strategies, then some will change to the orthotic intervention (custom remolding helmet). Healthy infants will only be followed, no intervention performed. All infants will be followed until 12 months of age.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Infants 2 months of age who have been diagnosed with a deformational head shape will be begin repositioning therapy (and physical therapy if torticollis is present) and be followed at least monthly. At 4, 5, and 6 months of age, if the head shape has not resolved, they will be given the option to pursue treatment with a cranial remolding orthosis. All affected infants will undergo active treatment until the head shape is resolved or the infant is 12 months of age (whichever comes first).

Normal infants will be evaluated at 2, 6, and 12 months of age and will not be enrolled in any active treatment.

All infants will return at 12 months of age for a final evaluation.

Eligibility criteria: Inclusion Criteria for Control Group:

* Healthy infants with normal physical development and no need for physical therapy intervention

Exclusion Criteria for Control Group:

* 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

Primary outcomes:
measure: Final Head Shape
timeFrame: 10 months after enrollment (at 12 months of age)
Secondary outcomes:
measure: Overall Change in Head Shape
timeFrame: Assessment to occur within 2 years of enrollment closure.
measure: Compliance with treatment
timeFrame: Assessment to occur within 2 years of enrollment closure.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Tiffany Graham
role: PRINCIPAL_INVESTIGATOR
References: