Monitoring System for Cranial Orthoses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-19

Study Completion Date

2026-06-01

Brief Summary

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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).

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Detailed Description

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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). 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.

Conditions

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Plagiocephaly Brachycephaly Deformational Plagiocephaly Deformational Posterior Plagiocephaly

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Cranial Remolding Orthosis

Intervention Type DEVICE

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

Interventions

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Cranial Remolding Orthosis

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

Intervention Type DEVICE

Other Intervention Names

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Custom Helmet

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* non-English speaking caregivers
* infants with craniosynostosis or those not indicated for cranial remolding
* infants with developmental comorbidities which affect cranial growth

Minimum Eligible Age

3 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No