Cranial Remolding Orthosis Registry
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorOtto Bock HealthCare LP
About this trial
A registry of infants fitted with a cranial remolding orthosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patient is geographically inaccessible to comply and participate in the registry.
Trial population
All infants who have been scanned and fitted with a cranial remolding orthosis
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
MyCRO Band
DeviceA 3D-printed cranial remolding orthosis
Traditional CRO
DeviceA traditionally manufactured cranial remolding orthosis such as the Orthomerica Starband
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Plagiocephaly2 interventions
Group B: Brachycephaly2 interventions
Trial outcomes
Primary outcomes
1
Asymmetry Index
Correction in Cranial Vault Asymmetry Index (Plagiocephaly) or Cephalic Index (Brachycephaly)
Time frame
Baseline to final follow up visit (est. 6 months)Secondary outcomes
1
Orthosis Utilization
Orthosis wear time will be measured from an embedded sensor
Time frame
Baseline to final follow up visit (est. 6 months)2
QUEST 2.0
Quebec User Evaluation of Satisfaction with Assistive Technology 2.0
Time frame
Final follow up visit (est. 6 months)Other outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: