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 Applications

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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44AR045153-03
Application #
6375086
Study Section
Special Emphasis Panel (ZRG1-SSS-5 (04))
Program Officer
Lester, Gayle E
Project Start
1998-04-01
Project End
2003-08-31
Budget Start
2001-09-01
Budget End
2003-08-31
Support Year
3
Fiscal Year
2001
Total Cost
$231,499
Indirect Cost
Name
Preventive Medical Technologies, Inc.
Department
Type
DUNS #
City
Philadelphia
State
PA
Country
United States
Zip Code
19119