Wednesday, May 14, 2025
5/14/2025
Smart Ankle-Foot Orthosis (Smart AFO) for Improved Stroke Outcomes - Project Goal: This two-year SBIR Phase II project will develop and validate a novel, wireless, smart ankle-foot orthosis (Smart AFO) system aimed to improve the functional walking outcome measures in individuals affected by stroke who use custom AFOs and address NIDILRR’s improved health and function outcome domain. Technical Objectives (TOs): TO 1 – Upgrade Smart AFO system. The Smart AFO design will be optimized and upgraded in preparation for the clinical trial and manufacturability. TO 2 – Enhance Smart AFO mobile app usability. The software facilitates automated gait data analysis to support an evidence-based practice by providing real-time patient gait data and device parameter optimization for patient functional improvements. TO 3 – Evaluate Smart AFO system with clinical orthotists and post-stroke individuals. Clinical roundtables with stakeholders will gather valuable input, an alpha clinical trial will validate the optimization algorithm, and a beta clinical trial will evaluate the effectiveness of the Smart AFO system as compared to current clinical practice. Outcomes and Products: Phase II demonstrates a commercial-ready, clinically tested SMART AFO system, which is composed of an instrumented AFO device that wirelessly communicates sensor information to a mobile software application that executes an algorithm to inform clinicians’ decisions on AFO parameters. Summary: Smart AFO enables clinicians to make better informed decisions on AFO adjustments which have been shown to be important for maximizing the safety and efficiency of walking post-stroke. The commercial opportunity exists with clinicians who desire to more efficiently optimize AFO alignment for improved gait in individuals post-stroke.
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).