BARRON ASSOCIATES, INC. — Department of Health and Human Services SBIR Phase II: NICHD

Description

PROJECT SUMMARY/ABSTRACT Introduction: The Motivating Occupational Virtual Experiences In Therapy for kids (MOVE-IT) SBIR Phase II program will support telehealth delivery of intensive rehabilitation for pediatric hemiplegia through smart toy- enabled games that inspire high-dosage, task-directed upper extremity (UE) movements. Although higher- dosage training is almost uniformly associated with better outcomes in UE rehabilitation [1], [2], [3], [4], achieving the repetitions necessary to attain lasting results through neuroplasticity is a formidable challenge. The MOVE- IT system will employ therapy games that combine virtual- and real-world physical elements to provide a turn- key solution suitable for both home and clinical use. MOVE-IT will engage patients in repetitive practice, facilitating an evidence-based approach that integrates proven concepts in constraint-induced movement therapy (CIMT) and other intensive therapy regimes [5]. This innovative solution employs a multi-sensory smart toy, advanced game engine, and low-cost motion tracking to create games that promote sustained adherence. Problem to be Addressed: Pediatric hemiplegia can result from Cerebral Palsy (CP) or acquired brain injury (including pediatric stroke, trauma, tumor, or other disease), and adversely affect motor functions essential to self-care, play, exploratory learning, and other daily activities [6]. Existing systems do not currently support telehealth delivery of the high-dosage, evidence-based therapy required for improvement in UE function. Long-Term Goals: Provide an effective home exercise program supported by remote guidance and monitoring of evidence-based treatment for pediatric hemiplegia. Improve patient participation and adherence to an intensive therapy regimen. Reduce the cost of, and improve access to, state-of-the-art rehabilitation. Provide validated metrics for remotely tracking patient status and progress. Phase I Results: Phase I produced a prototype smart toy, two UE therapy mini-games, human kinematics tracking software, and validated UE motor performance metrics. A pilot study was conducted at the University of Virginia (UVA) Children’s Hospital involving 10 children with hemiplegia. Analysis confirms the primary Phase I hypothesis that MOVE-IT generated metrics have high criterion validity with gold-standard measures of UE motor function. Patient/parent interviews/questionnaires strongly support the technology’s acceptance and usability. Phase II Summary: MOVE-IT Phase II will produce a commercial system including an enhanced smart toy and quest-based game software for sustained engagement over a full course of therapy; demonstrate efficacy; establish safety and usability; and pursue FDA-clearance. Phase II will culminate in a rater-blinded randomized, controlled trial to investigate efficacy in home use by children with hemiplegia, as measured by change in gold- standard measures of UE function for a cohort using MOVE-IT compared to a usual care treatment (UCT) group. Commercial Opportunity: High likelihood of commercialization is supported by Barron Associates’ past successes in development, clinical trials, FDA-clearance, and marketing of innovative technology for UE therapy.PROJECT NARRATIVEMOVE-IT is a mixed-reality system supporting evidence-based home exercise for pediatric hemiplegia with telehealth guidance and remote monitoring. A unique smart toy and dragon-themed therapy software supports delivery of intensive upper extremity rehabilitation through fun and engaging game experiences. The proposed SBIR Phase II program addresses important public health concerns by: (1) enabling telehealth delivery of evidence-based therapy; (2) making high-dosage therapy programs more enjoyable and cost effective; (3) improving access to remote and underserved areas by enabling home-based practice under parental supervision with remote monitoring and guidance by medical professionals; and (4) providing clinical study-validated, automatically-generated metrics for use by therapists to guide, track, and document patient progress.