This Small Business Innovation Research (SBIR) Phase I project seeks to demonstrate the technical and commercial viability of wireless instrumentation and smartphone technology used for feedback to amputees about their real-time performance for ubiquitous rehabilitation in situ. The goal is to improve the mobility and quality of life of persons with ambulatory disabilities (5.2% of U.S. adults ages 18-64). This research will provide a new paradigm for rehabilitation that occurs throughout the patient's daily life with reduced reliance on a therapist. The intellectual merit of the proposed research lies in the opportunity to profoundly transform the field of rehabilitation and to advance healthcare by enabling a fundamental shift toward low cost, ubiquitous rehabilitation that can be used away from the clinic. The technology seeks to provide feedback anytime and anywhere to enhance the proprioception - the sense of where limbs are in space- that has been impaired by disability. Active cueing (in contrast to current reactive cueing methods) will provide a more proprioceptive feedback that will better enable persons with amputations due to systemic complications (e.g. diabetes) to respond and make changes in their gait.
The broader impact/commercial potential of this project includes the focus on mobility limitations in persons with lower-limb amputations, which affect twice as many minorities as Caucasians. The commercial potential is vast: with diabetes as the major contributor to amputations, the number of amputees is forecast to triple to 3.6 million by 2050. In addition, the knowledge gained can be expanded to impact individuals with a wide variety of mobility limitations, e.g. stroke, Parkinson's disease, multiple sclerosis, cerebral palsy, etc. The orthopedic market- 773,000 total hip/knee replacements performed annually in U.S.- is also commercially relevant, as patients must effect an asymmetric gait following fracture repair or joint replacement to reduce weight-bearing on the healing limb. Another significant group are athletes seeking to improve performance or recover from injury through precision gait analysis and real-time feedback. In this Phase I proposal, this research will quantify the effect of this research by enabling persons with amputations due to diabetes to use individualized proprioceptive feedback and to participate in the design of the personalized feedback methods. This work will enable a wealth of information collected away from the clinic, including a way to investigate how and whether patients follow treatment protocols.
Overview: Amputations are life-changing events, resulting in an altered body and body image, mobility, and autonomy. Veristride’s Phase-I research targeted persons with lower limb amputations, with a goal of improving their mobility, and thus quality of life. Our Phase I SBIR proposal established the technical and commercial feasibility of the proposed Rapid Rehab innovation by resolving four key issues: Phase-I Technical Milestones and Results: Durability of Veristride insoles: Using a custom designed durability testing device, the proof of concept insole demonstrated consistent results for over 90 hours. This provides a durability of six months for customers using the insole for 30 minutes per day. Testing is ongoing to determine the upper limit of durability. Future durability tests will extend the test until multiple sensors fail with readings that have a change exceeding 10% from the initial readings, and will test the system with a 30 minutes on / 30 minutes off protocol. This will allow us to characterize the changes over a half hour of use, which is also of importance to users. A photograph of this testing device is included ("Veristride Insole Durability Tester") Use in amputees with systemic complications (e.g. diabetes): This shows promise, but needs further research. We started the Phase-I proposal with an assumption that an immediate need for feasibility was to demonstrate improvement in persons with systemic disease and peripheral neuropathy, particularly in patients with diabetes. In our efforts to plan strategy for technical studies in Phase-II and to better understand the complexities associated with medical reimbursement, we met early on with a consultant who is senior medical analyst with a local hospital and insurer. Our consultant strongly encouraged us to define a very specific patient population for our initial application, get to market, and then work on expanding to other groups of patients. With this advice towards the commercial feasibility of our system, we then turned our focus of these NSF Phase-I SBIR efforts to amputees without systemic disease affecting their intact limb. In parallel, we have submitted a separate applications to fund the research and development of a system for amputees with systemic disease such as diabetes. A photograph of the insole hardware + phone is included ("Veristride Rapid Rehab Insole and App Feedback"). Active cueing to enhance proprioception lost with amputation: This was found by the majority of prototype-testers to be very useful and intuitive. Results of the post-testing questionnaire indicated that 40% of the subjects selected the visual feedback mode as their favorite, 30% selected auditory, and 30% selected combined auditory and visual. When asked if the feedback modes made a noticeable difference in their gait, 60% agreed that the visual mode was effective, 50% agreed that the auditory mode was effective, and 50% agreed that the combined auditory and visual mode was effective. Only 10% of subjects felt that their stability worsened while wearing the RapidRehab, but 70% were willing to take the system home and wear it for up to three days. A screenshot of the prototype app interface can be seen in the photograph of the insole hardware + phone referenced above ("Veristride Rapid Rehab Insole and App Feedback"). Use by physical therapists in their patient care practices: Involvement of physical therapists will be critical to the commercial success of the device. Since we anticipate that many amputees will learn about the technology from their physical therapists that they meet during their initial rehabilitation. In order to better understand the complexities of this interaction, we met with twelve physical therapists in Utah. We presented our system and had a very candid conversation about how it would work in their practice. The group did not see RapidRehab as a threat, but as a product that would let them do their job more effectively and be leaders in their field. They were also excited about using it for many populations (particularly Parkinson’s disease and stroke) beyond amputees.
