Working with Physical Therapists to help patients improve walking function with the goal of discarding their assistive device
There are 5,000,000 stroke survivors in the US and 800,000 new strokes per year. Of these approximately 30% suffer from foot drop, a mobility disability inhibiting individuals from lifting their toe while walking making them a high fall risk. While stroke is a major cause of foot drop, it can also result from MS, Parkinson’s, diabetic neuropathy, and orthopeadic injuries or surgeries. Our customer interviews have informed us the existing 123,500 rehabilitation centers cannot effectively treat foot drop with current methods and are left prescribing archaic, rigid braces that immobilize the ankle. Any attempt to treat the condition outside of immobilizing the ankle is extremely labor intensive involving one or two Physical Therapists and is still ineffective. The current care options are so limited clinics either turn away patients looking for foot drop therapy or they only see them for a few weeks for a “tune-up” knowing there is no long-term reimbursement for the limited outcomes.
We are providing clinics the ability to offer personalized robotic therapy to patients through adaptive software that provides a personalized assist as needed approach. This is the first ever clinically proven option to effectively treat foot drop. Our robot is easy to use and designed to be run by lower skilled clinic staff freeing up therapists to focus on more hands modalities. As we collect more data, the software will transition into an AI-based system to assess and assigns training protocols optimized for each patient’s deficit. The improved outcomes will allow clinics to provide reimbursable therapy using existing CPT codes for gait training on a patient base they currently have no treatment for. The device will be registered with the FDA as a Class 1 Exercise Device; and so, it can be sold and used WITHOUT FDA APPROVAL. Allowing NextStep Robotics to immediately generate revenue through: 1) Direct sales/leasing of robots; 2) Subscription to software service; 3) Service contracts
85% of participants in a small randomized study self discarded their ankle foot orthotics or reduced dependance of their assistive devices. These results were seen years post stroke, well outside of the usual 3-6 month recvovery window.
Forrester LW, Roy A, Hafer-Macko C, Krebs HI, Macko RF. Task-specific ankle robotics gait training after stroke: a randomized pilot study. Journal of NeuroEngineering and Rehabilitation. 2016;13:51.
Brad started with Drs. Macko, Roy and Forrester as a Research Assistant/Exercise Physiologist in 2009 and quickly became a Study Coordinator. After a few years of successful study coordination and going back to school for his MHA and MBA he filled the role of Lead Clinical Research Specialist for the Maryland Exercise and Robotics Center of Excellence. There he managed the day to day activities for the center with over $6M in yearly funding. While maintaining that role he also assumed a more forward thinking role that has included creating budget ands and putting together federal grant applications for as much as $26M in federal funding in one year. It was in this role that he realized a potential key to clinical translation may lie in industry development. He has worked with this team and developed the business plan and commercialization plan that lead to the successful MII submission. Brad’s background in leadership started with earning his Eagle Scout and 8 years as a Corporal in the Maryland Army National Guard. From there he managed the research protocols for a multitude of investigators at the University of Maryland School of Medicine and the Baltimore VA Healthcare System.
Rich is a Professor of Neurology, Medicine, and Physical Therapy and Rehabilitation Science at University of Maryland (UM), School of Medicine (SOM). He graduated with Alpha Omega Alpha honors from Ohio State University, SOM, completed residency in Neurology at UCLA, and was awarded 2 years National Stroke Association Fellowship at USC. In 1993, he joined UM SOM and developed research models for task-oriented exercise to improve neurological function, heart, and brain health after stroke, for which he was later awarded the National Paul B. Magnuson Award for VA Excellence in Rehabilitation Research. In 1999, he began collaborating with MIT to develop lower extremity robotics for integration with mobility exercise, founded and directed a VA Maryland Exercise and Robotic Center for a decade, while receiving continuous VA and NIH Research funding to present. His research funding helped support the team in developing and testing ankle robotics in stroke. Dr. Macko has given >150 National or International presentations. He has >150 research publications, including 16 on ankle robotics, inclusive of 4 positive stroke clinical trials. Dr. Macko has conducted or collaborated on rehabilitation research at multiple sites in the USA, Europe, Canada, and the Caribbean. He has 20 years of experience reviewing NIH, VA, NSF, Canadian National grants and developing consensus recommendations on stroke rehabilitation, aging, and bioengineering. He currently sits on a Presidential Advisory Board, Physical Activity Guidelines Advisory Committee for 2018, focusing on chronic diseases, and brain health.
Associate Professor of Neurology in the University of Maryland, School of Medicine, Director of the Technology Core, Department of Veterans Affairs Rehabilitation Research & Development (VA RR&D) Maryland Exercise and Robotics Center of Excellence (MERCE), and Faculty at the Maryland Robotics Center, Institute for Systems Research at the University of Maryland at College Park. Prior to his current positions, he held prestigious postdoctoral fellowships at Georgia Institute of Technology (biomedical engineering) and at the Massachusetts Institute of Technology (rehabilitation robotics). Dr. Roy’s research interests are in human-robot interaction control, robot programming, and rehabilitation robotics, specifically ankle robotics for rehabilitation of gait and mobility function in neurologically disabled populations. Dr. Roy holds undergraduate and graduate degrees in electrical engineering (1998, JMI U.), control systems engineering (2000, U. Sussex), and engineering science & systems (2005, U. Arkansas). He has authored more than 40 research articles and frequently conducts peer-review for high impact journals in robotics and control systems engineering. Dr. Roy is the co-inventor of the control system for exoskeleton guided adaptive control across any joint, co-inventor of the portable ankle robot, and software architect for the command-and-control graphical user interface for robot-assisted mobility training.
Larry is the Director of the Baltimore VA Human Motor Performance Laboratory providing core resource support for the VA Geriatric Research Education and Clinical Center, the VA Maryland Exercise and Robotics Center of Excellence, and the Maryland Claude D. Pepper Older Americans Independence Center, as well as other funded projects requiring functional, biomechanical and/or neurophysiological outcomes. Formally trained in motor learning/control, biomechanics, and stroke rehabilitation, Dr. Forrester has over 18 years’ experience conducting rehabilitation research focused on therapeutic interventions to improve movement function after stroke and other neurological diseases. The broad aim of hi research has been to characterize intervention-induced changes in motor impairments, gait, balance, and reaching functions by linking underlying mechanisms of biomechanics, motor control, and motor learning to measures of central neuroplasticity through various methods, including transcranial magnetic stimulation, electro-encephalography, and MRI brain imaging. Recent work has included the development of lower extremity robotics and control systems (e.g., Anklebot) to promote motor learning and enhance therapeutic effects of exercise training on gait and balance after stroke. Related work has investigated the potential for decoding EEG for potential brain-machine interface with the Anklebot to enhance motor learning and brain plasticity.