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| Name | Class |
|---|---|
| National Institute on Disability, Independent Living, and Rehabilitation Research | FED |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infants with with deformational head shapes | Infants who have been referred for custom orthotic treatment for a deformational head shape such as deformational plagiocephaly or deformational brachycephaly. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cranial Remolding Orthosis | Device | A custom made FDA-approved cranial remolding orthosis will be retrofit with sensors used in the research. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wear time monitoring and validation | 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. | 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. |
| Fit monitoring | 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Survey Participation | Parents will take a survey regarding their experience with the research helmet | Survey to be taken at completion of the study, anticipated to be complete on all subjects within 1 year. |
| Wear time comparison between objective and subjective reporting |
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Inclusion Criteria:
Exclusion Criteria:
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Infants who are clinically indicated for cranial remolding orthoses.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tiffany Graham, MS | Contact | 2146458250 | Tiffany.Graham@utsouthwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tiffany Graham, MS | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
Individual participant data will be protected and only shared within the research team and treating practitioners.
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| ID | Term |
|---|---|
| D059041 | Plagiocephaly |
| D003398 | Craniosynostoses |
| D049068 | Plagiocephaly, Nonsynostotic |
| ID | Term |
|---|---|
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D000013 | Congenital Abnormalities |
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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. |
| 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. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013580 | Synostosis |
| D004413 | Dysostoses |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |