Effect of repositioning and helmet therapy on infant head shape
Effectiveness of Repositioning, Physical Therapy, and Cranial Remolding in Infants With Cranial Deformation
NA · University of Texas Southwestern Medical Center · NCT05917678
This study is testing if changing how caregivers position their babies and using special helmets can help improve head shape in infants with conditions like flat head syndrome.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 2 Months to 3 Months |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT05917678 on ClinicalTrials.gov |
What this trial studies
This study examines the effectiveness of caregiver repositioning strategies and custom cranial remolding orthoses in correcting deformational cranial shapes in infants. Infants diagnosed with conditions like plagiocephaly and torticollis will receive repositioning therapy and may be enrolled in physical therapy. If head shape issues persist, they will have the option to use a cranial remolding orthosis. A control group of healthy infants will be monitored for comparison. All infants will be evaluated at 12 months to assess treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include infants aged 2 months diagnosed with deformational head shapes or torticollis.
Not a fit: Patients with abnormal head shapes not related to deformational issues or significant developmental delays may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective non-surgical treatment options for infants with cranial deformation.
How similar studies have performed: Other studies have shown promising results with similar repositioning and orthotic approaches for treating cranial deformation in infants.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Tiffany Graham — University of Texas Southwestern Medical Center
- Study coordinator: Tiffany Graham, MSPO
- Email: Tiffany.Graham@utsouthwestern.edu
- Phone: 214-645-8250
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Deformational Plagiocephaly, Deformational Posterior Plagiocephaly, Brachycephaly, Torticollis, Congenital Muscular Torticollis, plagiocephaly, brachycephaly, asymmetrical brachycephaly