Sunday, May 11, 2025
5/11/2025
Feasibility of a Cranial Remolding Orthosis with Notification Electronics (CROWNE) - The proposed project aims to address the NIDILRR outcome domain of Health and Function. Goals – The team at Liberating Technologies, Inc. and the University of Texas Southwestern Medical Center propose to develop the Cranial Remolding Orthosis With Notification Electronics (CROWNE) to improve the safety and outcomes of cranial remolding treatment. The goal of this effort is to collect previously unmeasured pressure data from at-home treatment with cranial remolding orthoses (CROs) to create a fully verified prototype CROWNE warning system ready for validation testing. Objectives – In order to achieve the goal described above, we plan to: (1) Refine and miniaturize the technology based on input from an expert panel and user focus group to create fully verified CROWNE prototypes ready for at-home testing; (2) Perform pre-clinical pilot take-home testing to monitor pressures in the CRO over the course of 2 months of treatment on 12 pediatric subjects, and (3) to use the collected pressure and clinical observations to develop preliminary algorithms that will be used by the CROWNE system to provide feedback to caregivers and clinicians. Outcomes and Products – The outcomes are never before measured pressure data from at home CRO treatment that can be used to develop the CROWNE warning system and ultimately improve the treatment and clinical outcomes for craniosynostosis and deformational plagiocephaly patients. Products – The products of this Phase II study will be fully verified prototypes of a monitoring and warning system for CRO treatment that is ready for a larger future clinical trial to validate the CROWNE system.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).