Virtual Activities of Living for Occupational Rehabilitation - PROJECT SUMMARY/ABSTRACT Introduction: The Virtual Activities of Living for Occupational Rehabilitation (VALOR) SBIR program supports telehealth delivery and remote monitoring of upper extremity (UE) stroke rehabilitation through immersive practice of virtual activities of daily living (ADLs) and instrumental ADLs (IADLs). The VALOR system marries ground-breaking untethered virtual reality (VR) headset technology and deep learning runtime 3D human motion tracking with a library of digital ADL/IADL therapy games to enable functional, repetitive task practice at home with telehealth support. Key differentiators from other VR therapy offerings are (1) practice of ADLs/IADLs (not just games) involving realistic activities and manual interaction, (2) fully immersive, ecologically valid environments, (3) dramatic simplification of system hardware by using the tracking cameras built into the VR headset to track the UEs (no additional sensors required), and (4) an order of magnitude cost reduction enabling at home use. Problem to be addressed: VALOR addresses the critical challenges of: (1) improving outcomes in UE stroke therapy through repetitive task practice and mental imagery that promote functional recovery; (2) enabling increased dosage, intensity, and duration through independent home use and teletherapy; (3) minimizing total cost of rehabilitation by reducing patient/therapist travel; and (4) improving stroke therapy services to underserved populations and regions. Long-Term Goal: Improved outcomes and functional independence for patients with acquired brain injury. Phase I Results: A successful VALOR SBIR Phase I pilot study conducted by Duke University completed by 16 stroke patients (44% Black or African American) has established the usability and technology acceptance of a prototype immersive VR system for UE therapy. Careful design of the VR activities resulted in excellent (low) cybersickness scores. The effort also demonstrated the validity of metrics derived during immersive virtual ADL/IADL practice for tracking a patient’s UE motor status, enabling telehealth monitoring and delivery. Phase II Summary: A VALOR Phase II will include: (1) development of a market-ready product with a ten-fold reduction in cost compared to existing VR therapy systems; (2) a Phase II rater-blinded RCT that provides efficacy and safety data required for regulatory compliance; (3) establishing conformity with applicable FDA, FCC, ISO, and IEC regulations and standards; and (4) preparation of FDA clearance and CE Marking packages. Commercial Opportunity: Approximately 50% of the 800,000 individuals hospitalized due to stroke each year in the U.S. suffer from chronic deficits in hand and/or arm function [1], [2]. VALOR is poised to rapidly transition the Phase II product to market by leveraging an existing brand with well-defined distribution channels.
