This Small Business Innovation Research (SBIR) Phase II project will advance the technology research and development necessary to bring wireless instrumentation and smartphone technology used for feedback to lower-limb amputees about their real-time performance, for rehabilitation in situ. The intellectual merit of the proposed research lies in the opportunity to 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. This proposal will research and develop the pre-market alpha- and beta-prototypes of an instrumented insole, smartphone app, and HIPAA-compliant data transfer and remote server storage and analysis system, as an essential and transformative tool utilized for physical therapy and gait training outside of the clinic. While sensors have become small, inexpensive, and highly available, many research lab applications are limited to proof-of-concept evaluations that involve tethered systems and/or post-processing of the data. This research quantifies the effect of this low-cost, personalized, wireless assistive technology that can be used away from the clinic. Ultimately, this work lays a foundation for more complex rehab feedback systems, e.g. using a smartphone to detect gait and provide feedback to an orthotic or prosthetic for muscle stimulation.
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 of this wireless assistive technology is vast: with diabetes as the major contributor to amputations, the number of amputees is forecast to triple to 3.6 million by 2050. 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 affect 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 II proposal, this research will quantify the effect of this wireless assistive technology by enabling persons with amputations 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.
