Asymmetric Head, Brachycephaly, Plagiocephaly
Conditions
Keywords
CRO, MyCRO, Cranial Helmet, Cranial Orthosis, Cranial Remolding Orthosis
Brief summary
A registry of infants fitted with a cranial remolding orthosis.
Detailed description
The intention of the CRO registry is to gather real-world data of traditional and 3D-printed cranial remolding orthoses to compare outcomes.
Interventions
DEVICEMyCRO Band
A 3D-printed cranial remolding orthosis
DEVICETraditional CRO
A traditionally manufactured cranial remolding orthosis such as the Orthomerica Starband
Sponsors
Otto Bock HealthCare LP
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient has been evaluated and successfully scanned for a MyCRO Band or similar CRO * Patient's parent(s) or legal guardian(s) are able to communicate, provide feedback, understand and follow instructions during the course of the registry. * Parent(s) or legal guardian(s) are willing to provide informed consent.
Exclusion criteria
* Patient is geographically inaccessible to comply and participate in the registry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asymmetry Index | Baseline to final follow up visit (est. 6 months) | Correction in Cranial Vault Asymmetry Index (Plagiocephaly) or Cephalic Index (Brachycephaly) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Orthosis Utilization | Baseline to final follow up visit (est. 6 months) | Orthosis wear time will be measured from an embedded sensor |
| QUEST 2.0 | Final follow up visit (est. 6 months) | Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Impact of torticollis on compliance | Baseline to final follow up visit (est. 6 months) | Percent reduction of wear time when torticollis is severe |
| Cranial Temperature | Baseline to final follow up visit (est. 6 months) | Average temperature of the infant's head will be assessed by an embedded temperature sensor |
| Frequency of additional fittings | Baseline to final follow up visit (est. 6 months) | Measuring the number of times the orthosis had to be refitted to accommodate changes in head shape |
| Impact of delays on correction of asymmetry | Baseline to final follow up visit (est. 6 months) | Percent reduction of asymmetry correction when delivery is delayed more than two weeks |
| Duration of therapy | Baseline to final follow up visit (est. 6 months) | Average amount of time, in months, that the CRO was used |
Countries
United States
Contacts
Primary ContactJared Howell
Outcome results
None listed