An observational study in Plagiocephaly, Brachycephaly and Asymmetric Head, sponsored by Otto Bock HealthCare LP. Not yet recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-01-07.
Sponsored by Otto Bock HealthCare LP · Observational
A registry of infants fitted with a cranial remolding orthosis.
The intention of the CRO registry is to gather real-world data of traditional and 3D-printed cranial remolding orthoses to compare outcomes.
16 studies on the registry are indexed under Plagiocephaly; 4 are open to participants now.
Browse Plagiocephaly studies →This is the only study on the registry with Otto Bock HealthCare LP as lead sponsor.
Counted across the registry records on this site, refreshed daily.
All infants who have been scanned and fitted with a cranial remolding orthosis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Infants diagnosed with plagiocephaly who have been scanned for a cranial remolding orthosis
Device: MyCRO Band · Device: Traditional CRO
Infants diagnosed with brachycephaly who have been scanned for a cranial remolding orthosis
Device: MyCRO Band · Device: Traditional CRO
A 3D-printed cranial remolding orthosis
A traditionally manufactured cranial remolding orthosis such as the Orthomerica Starband
Asymmetry Index
Correction in Cranial Vault Asymmetry Index (Plagiocephaly) or Cephalic Index (Brachycephaly)
Time frame: Baseline to final follow up visit (est. 6 months)
Orthosis Utilization
Orthosis wear time will be measured from an embedded sensor
Time frame: Baseline to final follow up visit (est. 6 months)
QUEST 2.0
Quebec User Evaluation of Satisfaction with Assistive Technology 2.0
Time frame: Final follow up visit (est. 6 months)
Cranial Temperature
Average temperature of the infant's head will be assessed by an embedded temperature sensor
Time frame: Baseline to final follow up visit (est. 6 months)
Impact of delays on correction of asymmetry
Percent reduction of asymmetry correction when delivery is delayed more than two weeks
Time frame: Baseline to final follow up visit (est. 6 months)
Duration of therapy
Average amount of time, in months, that the CRO was used
Time frame: Baseline to final follow up visit (est. 6 months)
Impact of torticollis on compliance
Percent reduction of wear time when torticollis is severe
Time frame: Baseline to final follow up visit (est. 6 months)
Frequency of additional fittings
Measuring the number of times the orthosis had to be refitted to accommodate changes in head shape
Time frame: Baseline to final follow up visit (est. 6 months)
Plan to share: Undecided — No plans have been made to share IPD
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.