Brachycephaly, Deformational Plagiocephaly, Deformational Posterior Plagiocephaly, Plagiocephaly
Conditions
Brief summary
This is a study which investigates the wear time and fit of a cranial remolding orthosis (a standard-of-care treatment where an infant wears a custom helmet to help reshape their head as they grow).
Detailed description
This is a study which investigates the wear time and fit of a cranial remolding orthosis (a standard-of-care treatment where an infant wears a custom helmet to help reshape their head as they grow). Although cranial remolding treatment has been used successfully for over 20 years, there is no clinical standard for objective monitoring of the fit and wear time. In total, participation will consist of 7 visits over 11 weeks: (1) measurements and clinical evaluation \[approximately 60 minutes\], (2) fitting of standard helmet and pre-fitting and/or fitting of the research helmet \[approximately 60 minutes\], (3) fitting of research helmet (if not done at Visit #2) and in-office testing \[approximately 2 hours\], (4)/(5)/(6) follow up visits for research helmet \[approximately 30-60 minutes each\], and (7) final follow up visit and in-office testing for the research helmet \[approximately 2 hours\]. During the 8-9 weeks of wearing the research helmet, the child is expected to wear the it 23 hours per day (after a break-in schedule), and caregivers will keep a log of helmet wear time and any side effects (such as skin irritations), if they occur. The child will be seen clinically every 2 weeks (or more often, if caregivers request additional checkups). At the end of the trial, participants will return all research-related materials and the treating clinician will return the child to wearing the standard helmet.
Interventions
A custom made FDA-approved cranial remolding orthosis will be retrofit with sensors used in the research.
Sponsors
University of Texas Southwestern Medical Center
National Institute on Disability, Independent Living, and Rehabilitation Research
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Months to 18 Months
Healthy volunteers
No
Inclusion criteria
* Infants who are clinically indicated for cranial remolding orthoses for treatment of a deformational head shape (i.e. plagiocephaly / brachycephaly)
Exclusion criteria
* non-English speaking caregivers * infants with craniosynostosis or those not indicated for cranial remolding * infants with developmental comorbidities which affect cranial growth
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wear time monitoring and validation | Data will be recorded for 8-9 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year. | The temperature readings from the custom temperature sensor within the research helmet will be compared to the collected temperature readings from the iButtons. Using established software compatible with the iButton, wear time will be calculated based on previously reported temperature thresholds which indicate the helmet is being worn. Using similar temperature thresholds, wear time data from the custom sensors will be compared to the wear time reported by the iButton software. |
| Fit monitoring | Data will be recorded for 8-9 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year. | The investigators will examine pressure in the void space of the helmet throughout the 8-9 weeks of wear time. In theory, the pressure in this area should never increase as the cranium should not come in contact with this sensor no matter what position the infant is in (i.e. laying down, sitting, etc). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survey Participation | Survey to be taken at completion of the study, anticipated to be complete on all subjects within 1 year. | Parents will take a survey regarding their experience with the research helmet |
| Wear time comparison between objective and subjective reporting | Data will be recorded for 8-9 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year. | The wear time based on iButton and custom temperature readings will be compared to the caregiver-reported wear time log and any differences in log times reviewed. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTiffany Graham, MS
University of Texas Southwestern Medical Center
Outcome results
None listed