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Monitoring System for Cranial Orthoses

NCT06425172 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2025-07-03

No results posted yet for this study

Summary

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).

Conditions

  • Plagiocephaly
  • Brachycephaly
  • Deformational Plagiocephaly
  • Deformational Posterior Plagiocephaly

Interventions

DEVICE

Cranial Remolding Orthosis

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

Sponsors & Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

    collaborator FED

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Tiffany Graham, MS · University of Texas Southwestern Medical Center

Eligibility

Min Age
3 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-19
Primary Completion
2026-06-01
Completion
2026-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06425172 on ClinicalTrials.gov