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Feasibility of a Cranial Remolding Orthosis with Notification Electronics (CROWNE)

Award Number: 90BISB0031
ORGANIZATION: NATIONAL INSTITUTE ON DISABILITY, INDEPENDENT LIVING, AND REHABILITATION RESEARCH
OPDIV: ACL
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: OTHER
PERIOD OF PERFORMANCE START DATE: 06/01/2023
PERIOD OF PERFORMANCE END DATE: 05/31/2026

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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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	LIBERATING TECHNOLOGIES INC	325 HOPPING BROOK RD STE A	HOLLISTON	MA	01746	MIDDLESEX	USA	ACL National Institute on Disability, Independent Living, and Rehabilitation Research	01	2	4/15/2025	EXTENSION WITH OR WITHOUT FUNDS	$0
2025	2023	LIBERATING TECHNOLOGIES INC	325 HOPPING BROOK RD STE A	HOLLISTON	MA	01746	MIDDLESEX	USA	ACL National Institute on Disability, Independent Living, and Rehabilitation Research	01	2	4/15/2025	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $287,406 )
2024	2024	Liberating Technologies Inc	325 HOPPING BROOK RD STE A	HOLLISTON	MA	01746	MIDDLESEX	USA	ACL National Institute on Disability, Independent Living, and Rehabilitation Research	00	2	5/2/2024	NON-COMPETING CONTINUATION	$287,406
2024	2023	Liberating Technologies Inc	325 HOPPING BROOK RD STE A	HOLLISTON	MA	01746	MIDDLESEX	USA	ACL National Institute on Disability, Independent Living, and Rehabilitation Research	00	2	5/2/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $287,406

Issue Date FY: 2023 ( Subtotal = $287,426 )
2023	2023	LIBERATING TECHNOLOGIES INC	325 HOPPING BROOK RD STE A	HOLLISTON	MA	01746	MIDDLESEX	USA	ACL National Institute on Disability, Independent Living, and Rehabilitation Research	00	1	5/24/2023	NEW	$287,426
														Subtotal = $287,426

Grand Total All Awards = $574,832

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Feasibility of a Cranial Remolding Orthosis with Notification Electronics (CROWNE)

Award Number: 90BISB0031

ORGANIZATION: NATIONAL INSTITUTE ON DISABILITY, INDEPENDENT LIVING, AND REHABILITATION RESEARCH

OPDIV: ACL

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: OTHER

PERIOD OF PERFORMANCE START DATE: 06/01/2023

PERIOD OF PERFORMANCE END DATE: 05/31/2026

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