SBIR-STTR Award

Symptomatic osteoarthritis (OA) of the knee affects millions of Americans. Although isometric strengthening maintains function and reduces pain among people with OA, only 2% exercise. We propose that the devise will realize a popular, isometric quadriceps/hamstring strengthening program for use at home. By incorporating our patented force sensor, this product will build adherence through continuous readout of isometric force. In operation, the user turns on the device and chooses a force threshold, place the device between the ankles while comfortably seated, and presses the legs together. The device automates exercise thereafter, audibly cueing when to apply force, rest and stop. During phase I, we will add an auto-off and event counter to existing microprocessor circuitry, and fabricate a rugged, attractive housing. Extensive electrical, mechanical and material testing will follow to insure feasibility. Lastly, between 5-10 subjects will receive isometric quadriceps/hamstring strengthening under supervision for eight weeks. We will compare pre-and post-trial isometric strength and quantify pain/stiffness/disability score (WOMAC). Data will determine power required to establish significance in Phase II clinical trials, which will investigate strength, function and adherence improvement with the device used unsupervised at home.Proposed Commercial Applications:A home exercise program built around an isometric exercise device could be of enormous benefit to the estimated 7.5 million people with painful knee osteoarthritis, the umber expected to double by 2020. If it is positively demonstrated to motivate consumers to exercise, resulting in health benefits (increased strength, decreased pain and disability), then this product could certainly be commercialized successfully. Insurance reimbursement approval might follow positive outcomes of an SBIR phase II, leading to an expected high market penetration and rate of return. Market penetration could approach 5 percent even without insurance reimbursement, resulting in a market of greater than 50 million dollars.

Thesaurus Terms:
biomedical equipment development, clinical biomedical equipment, exercise, knee, osteoarthritis biomedical automation, cue, muscle strength clinical research, human subjectNAT INST OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES

Performing routine isometric exercises has been shown to aid in the management of osteoarthritis and is an exercise suggested by the Arthritis Foundation. However, there has been no effective way to assess isometric exercise performance (i.e., measure strength), causing those who exercise to likely abandon the exercise altogether. PMT addressed this problem by developing an electronic force measurement device, the Isopad(TM), that will motivate subjects to isometrically exercise the knee in a home program. Phase I technical aims have been met and exceeded in many cases. A pilot clinical trial (n=5) was performed under PT supervision. Over the eight-week program a muscle-specific 30% average strength increase, a 30% pain and stiffness reduction, and a 15% increase in function was found. Individuals with mild to moderate osteoarthritis, as a group, fired best, suggesting that the Isopad(TM) may act as a preventive device. Phase II addresses device redesign and proposes a multi-center clinical trial (120 subjects in four groups) that will test the efficacy of the Isopad(TM) as the basis for an eight-week, unsupervised home exercise program. Study conclusions and a long-term follow up will eventually result in insurance reimbursement and-extend the use of the Isopad(TM) into elder fitness programs. PROPOSED COMMERCIAL APPLICATION: The Isopad(TM) will be of enormous benefit to individuals with osteoarthritis (OA) of the knee. We estimate the number of these individuals to be 10 million today, a number that will double by 2020. When proven to decrease pain and stiffness, and increase function, strength and overall quality-of-life, end-users and insurers will warmly receive the Isopad(TM). Expected market penetration is 10%, with a worldwide market potential in excess of $150 M. Uses of the device for pathologies other than OA of the knee are expected which would increase market potential dramatically