Phase I Amount
$2,745,978
This proposal demonstrates a novel healthcare delivery system that has the potential to significantly advance stroke rehabilitation monitoring and therapy. The broad, long-term objective is to provide accessible, affordable stroke care for people in rural and underserved areas. A major public health issue is the variability in the quality and quantity of treatment that stroke survivors receive based on their proximity to major metropolitan medical centers. This proposal evaluates a system of stroke patient monitoring and delivery of state-of-the-art stroke therapy for that is accessible for rural residents. This comprehensive rehabilitation delivery system utilizes Web-based platforms for storage and retrieval of patient information in conjunction with easy-to-use robot therapy devices that can be remotely monitored. Collected data are automatically entered into the system and sent to a data center (transparent to the user), where the information is monitored by a clinician through a secure website. To demonstrate the functionality of the system, an existing user-friendly home-compatible stroke therapy robotic device is utilized. A randomized, controlled, multisite clinical trial is designed to evaluate this combination of controlled rehabilitation therapy for stroke survivors with telehealth components. The model can be generalized in the future with the use of other home-based therapy and monitoring devices as needed for a specific patient. Fostering effective home treatments through the use of these devices will help determine the difference between functional independence and nursing home placement. The clinical trial will enroll 96 stroke patients and treat them at home for three months. These important considerations combine contemporary technology for service delivery and the potential for cost-savings. In a relatively short time, these advances will have a major beneficial impact on the delivery of stroke therapy to millions of rural stroke survivors. Kinetic Muscles, Inc. is an emerging company developing state-of-the-art therapy devices to fundamentally improve rehabilitation for people with neurologic injury such as stroke or traumatic brain injury (TBI). As an early stage medical device company, we regularly seek private funding to support growth objectives. Funding of this proposal would not only allow KMI to retain and add four full-time research and development personnel but would also facilitate additional funding from the private investment community to accelerate market deployment of innovative telerehabilitation therapy. This strategy has the realistic capability to provide a new level of accessible, affordable rehabilitative care for stroke patients. It is estimated that this current proposal will also create or retain four jobs between the Cleveland Clinic and Emory University.
Public Health Relevance: The purpose of this research is to evaluate a therapy delivery system for stroke patients that provide accessible, affordable stroke care. User-friendly home therapy robots and a telerehabilitation system are combined to monitor and provide therapy that is accessible for patients in rural and underserved locations.
Public Health Relevance Statement: Narrative The purpose of this research is to evaluate a therapy delivery system for stroke patients that provide accessible, affordable stroke care. User-friendly home therapy robots and a telerehabilitation system are combined to monitor and provide therapy that is accessible for patients in rural and underserved locations.
Project Terms: Acceleration; Action Research; Activities of Daily Living; Activities of everyday life; Address; Adoption; American; Apoplexy; arm; Art Therapy; Arts; base; Biomedical Research; Biomedical Technology; body movement; brain attack; care delivery; Caring; Cerebral Stroke; cerebral vascular accident; Cerebrovascular accident; Cerebrovascular Apoplexy; Cerebrovascular Stroke; Cessation of life; Chronic; Clinic; Clinical; clinical data repository; clinical data warehouse; clinical investigation; clinical research site; clinical site; Clinical Trials; Clinical Trials, Unspecified; Communication; Communities; cost; Cost Savings; daily living functionality; Data; Data Banks; Data Bases; data repository; Databank, Electronic; Databanks; Database, Electronic; Databases; Death; Delivery of Health Care; design; designing; Development; Development and Research; Devices; economic value; Effectiveness; enroll; Enrollment; Ethics Committees, Research; evidence base; experience; Extremities; Fostering; Foundations; Frequencies (time pattern); Frequency; function improvement; functional ability; functional capacity; functional improvement; Funding; Future; Generalized Growth; Goals; Grant; group intervention; Growth; Hand; Hand functions; Health; health care delivery; health care quality; health related quality of life; Health Sciences, Allied and Health Services Delivery; Healthcare Delivery; Healthcare Systems; Home; Home environment; Human; Human Resources; Human, General; Impairment; improved; Injury; innovate; innovation; innovative; Institutional Review Boards; intervention therapy; Investments; IRBs; Jobs; Kinetic; Kinetics; Limb structure; Limbs; Link; Location; Man (Taxonomy); Man, Modern; Manpower; Marketing; Measures; Medical; Medical center; Medical Device; Membrum superius; Methods; metropolitan; Modeling; monetary value; Monitor; monitoring device; Motor; motor impairment; Movement; Muscle; Muscle Tissue; Nature; Nervous System Diseases; nervous system disorder; Neurologic; Neurologic Disorders; Neurological; neurological disease; Neurological Disorders; new technology; Non-Trunk; novel; nursing home; Nursing Homes; Occupations; On-Line Systems; online computer; Online Systems; ontogeny; Outcome; Participant; Patient Monitoring; Patients; personnel; Physical Health Services / Rehabilitation; post stroke; poststroke; primary outcome; Professional Postions; programs; Programs (PT); Programs [Publication Type]; prospective; Protocol; Protocols documentation; Public Health; public health medicine (field); public health relevance; QOL; Quality of Health Care; Quality of Healthcare; Quality of life; R & D; R&D; randomisation; randomization; Randomized; randomized controlled study; Randomized Controlled Trials; randomly assigned; rehab device; Rehabilitation; Rehabilitation device; Rehabilitation therapy; Rehabilitation, Medical; rehabilitative; relational database; Research; research and development; Research Ethics Committees; Research Resources; Residual; Residual state; Resources; response; Retrieval; Robot; robot assistance; robot assisted; robotic assistance; robotic device; Robotics; Rural; Rural Community; Saving, Cost; secondary outcome; Secure; Self-Administered; Services; Site; Staging; Stimulus; stroke; Stroke; stroke recovery; stroke rehab; stroke rehabilitation; stroke therapy; Survivors; System; System, LOINC Axis 4; Systems, Health Care; Technology; telehealth; Telemedicine; telerehabilitation; Testing; Therapeutic Intervention; Time; Tissue Growth; Trauma, Brain; traumatic brain damage; Traumatic Brain Injury; Traumatic encephalopathy; treatment effect; underserved rural area; Universities; Upper Extremity; Upper Limb; user-friendly; Using hands; Vascular Accident, Brain; volunteer; web based; web site; Wolves
