Effect of repositioning and helmet therapy on infant head shape
Official title: Effectiveness of Repositioning, Physical Therapy, and Cranial Remolding in Infants With Cranial Deformation
Run by University of Texas Southwestern Medical Center · NCT05917678 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 2 Months to 3 Months |
| Sex | All |
| Enrollment | 65 (estimated) |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Status | Recruiting |
| Started | May 23, 2023 |
| Main results expected | August 1, 2027 |
| Study ends | August 1, 2027 |
| Registry record updated | August 31, 2026 |
| Trial ID | NCT05917678 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include infants aged 2 months diagnosed with deformational head shapes or torticollis.
✕Probably not a fit
Patients with abnormal head shapes not related to deformational issues or significant developmental delays may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promising results with similar repositioning and orthotic approaches for treating cranial deformation in infants.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.