Health TrialsbyHealthPanel

Monitoring System for Cranial Orthoses

ConditionsPlagiocephalyBrachycephalyDeformational PlagiocephalyDeformational Posterior Plagiocephaly
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-18
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Infants who are clinically indicated for cranial remolding orthoses for treatment of a deformational head shape (i.e. plagiocephaly / brachycephaly)

Disqualifiers

non-English speaking caregivers

infants with craniosynostosis or those not indicated for cranial remolding

infants with developmental comorbidities which affect cranial growth

Trial population

Infants who are clinically indicated for cranial remolding orthoses.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cranial Remolding Orthosis

    Device

    A custom made FDA-approved cranial remolding orthosis will be retrofit with sensors used in the research.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Infants with with deformational head shapes1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.
2

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).

Time frame
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.

Secondary outcomes

1

Survey Participation

Parents will take a survey regarding their experience with the research helmet

Time frame
Survey to be taken at completion of the study, anticipated to be complete on all subjects within 1 year.
2

Wear time comparison between objective and subjective reporting

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.

Time frame
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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas Southwestern Medical Center

Lead sponsor

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Source ClinicalTrials.gov
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