(Fast-Track proposals will not be accepted. Phase II information is provided only for informational purposes to assist Phase I offerors with their long-term strategic planning.) Number of anticipated awards: 1 to 3 Budget (total costs, per award): Phase I: $325,000 for 9-12 months; Phase II: $2,000,000 for 2 years It is strongly suggested that proposals adhere to the above budget amounts and project periods. Proposals with budgets exceeding the above amounts and project periods may not be funded. Summary: The objective of this contract is to develop a multi-modal virtual reality environment for remote use enabling physicians and healthcare providers to guide rare disease patient therapy while automatically obtaining crucial health metrics. Genetic and rare diseases are often chronic debilitating disorders for which patients require life-long individualized care, and which frequently require longer and more frequent visits with their physicians and healthcare providers than for typical patients. Given the small numbers of patients with each rare disease and few specialists with expert knowledge about these disorders, an understanding of the clinical characteristics and course of a rare disease often resides with patients and caregivers who are geographically scattered throughout the country. . Thus, there is a need for rare disease patients to receive active feedback pertaining to their health and disease progression, as well as to engage patients to positively enable the healing process. Engagement of rare disease physicians and healthcare providers can also be a challenge given the frequent lack of measurable outcome assessment tools to monitor patients over the long-term for both disease progression and the benefits of therapeutic intervention, and the need for seamless coordination with a multi-disciplinary care team. Additionally, rare diseases disproportionately affect children and adolescents, and the repetitive often boring nature of physical and occupational therapies can lead to disengagement and a lack of motivation to continue these interventions outside of the clinic. Rare disease patients may also be located far from expert medical centers, have difficulty with travel due to the severity of their conditions, and in the event of National emergencies (i.e. pandemics), many rare disease patients experience disproportionate interruptions in medical care. These issues are especially difficult for rare disease patients in rural or low-income communities (“medical deserts”). While current video-conferencing capabilities enable communication, they lack the interpersonal connections between healthcare providers and patients, and the ability to accurately assess functional measures over the course of treatment, such as joint mobility, forces/timing of physical movement, global activity, or accurate assessment of heart/respiratory rate. Thus, there is a critical need for rare disease patients to have the ability to remain home with continued access to high-quality teletherapy and remote monitoring. To address the needs for user engagement and remote metrics for rare disease patients, physicians, therapists and healthcare providers are collaborating to develop an immersive VR environment for physical and occupational therapy and rehabilitation. The experience provides a remote medium to monitor user pain, discomfort, mobility, and biometrics during a prescribed therapeutic exercise session. Research has indicated that immersion afforded by VR can reduce pain and discomfort in the physical medicine and rehabilitation context. However, perception of immersion is highly individualized and context-dependent to the patient. To address the needs for user engagement and remote metrics, physicians, therapists and healthcare providers are working with developers to advance an immersive VR environment for physical and occupational therapy and rehabilitation. Efforts in game design mechanics through multi-modal immersion such as haptic feedback vests, olfactory masks, and other emerging technologies are being investigated to understand how to best design healthcare experiences for emotional engagement and interpersonal connection. These metrics can provide a remote medium for physicians and therapists to understand patient movement and engagement in therapy protocols. Now, these efforts should evolve into an interactive environment so physicians and healthcare providers and rare disease patients can meet remotely and still receive quality care. Project Goals: The purpose of this project is to create a virtual reality therapy environment for remote use enabling physicians and healthcare providers to provide quality care for rare disease patients outside of their offices or clinic settings. Offerors will address the current limitations with teletherapy by creating features to guide patients and gather relevant metrics necessary for physicians and healthcare providers. We want to address the challenges of disengagement and frustration by creating a stimulating, enjoyable and easy to use virtual environment for rare disease patients. To this end, the goal of this project is to translate rare disease patient care into virtual reality through (1) automated health metrics utilizing an immersive virtual reality systems motion capture, (2) remote healthcare provider-patient interaction through virtual avatars in a 6 degrees of freedom (6-DoF) environment, and (3) a series of games that are customizable by the healthcare provider for physical, functional, cognitive, or behavioral exercises for the rare disease patient to be played independently. An optimal outcome would be the creation of a system for physicians and healthcare providers to adopt beyond shelter in place that would have the following benefits: ● Increase physician and healthcare provider accessibility to rare disease patients through virtual clinics and at-home meetings. ● Increase rare disease patient motivation and engagement to therapy protocol through gamification. ● Monitor and document compliance with therapy protocols through remote capture. ● Optimize healthcare provider time by automating analysis of patient specific health metrics. ● Personalize rare disease patient therapeutic exercises through a tunable environment for both the patient and physician. ● Provide real-time rare disease patient feedback through web-based analytic dashboards. ● Provide engagement through virtual environments to aid in physical, functional, cognitive or behavioral exercises. ● Enable a standardized platform for collecting remote health data. For this process to be possible several key components will be required as described in the Phase 1 Activities and Expected Deliverables section. Phase I Activities and Expected Deliverables: ● An immersive virtual reality environment with a minimum of the following capabilities: ○ An avatar representation for remote patient- healthcare provider interaction. ○ A WebXR instance of the experience through the Unity Game Engine to enable usage on any VR device through the world-wide web. ○ Sensing capabilities to perform runtime health analytics for physician observation. ● An analytics dashboard for patient- healthcare provider interpretation both in and outside of the virtual environment. ○ An algorithm for automated runtime health informatics to provide rare disease patient engagement, discomfort, kinematics, dynamics, and muscle force estimation. ○ Representations of functional assessment for the patient’s avatar in immersive virtual reality through force vectors and heatmaps. ○ A modular dashboard for representations of targeted health informatics. ○ Verification of secure and ethical data practices for remote data collection. ● A method of personalized gamification for physician prescribed exercises. ○ A customizable background environment to change the audio-visual stimuli of the user’s virtual health experience. ○ An adaptive input system to enable the addition of immersive peripherals such as haptic feedback vests, olfactory masks, gaze-based systems, and custom controllers for accessibility and variable immersion. ○ A physical exercise game for physicians to record desired movements and prescribe them to patients. ○ A mindfulness exercise game for healthcare providers to record desired breathing patterns and mediation lengths and prescribe them to patients. ● Assemble appropriate expertise in their teams to meet statement of work goals, which could include clinicians, occupational therapists, physical therapists and other appropriate subject matter experts depending on the deliverables of the contract. ● Provide NCATS with all data and materials resulting from Phase I Activities and Deliverables. Phase II Activities and Expected Deliverables: ● Build a prototype virtual experience that meets the Phase I specifications. ● Provide a test plan to evaluate every feature of the virtual experience. ● Provide NCATS with all data from each executed test to properly evaluate each test condition. ● Develop a robust web server for the virtual experience, using compliant secure components and minimizing expense where possible. ● Provide NCATS with all data resulting from Phase II Activities and Deliverables. ● Assemble appropriate team/expertise to perform deliverables of the contract ● Provide NCATS with all data and materials resulting from Phase II Activities and Deliverables.