The main objective of this Phase I STTR research and development effort is to test the clinical efficacy of a newly patented biomedical device, called a Snap Dome Weight Bearing Indicator (WBI), which is intended to provide a simple, effective, noninvasive and inexpensive device for patients with lower extremity injuries to self-monitor their weight bearing status as required by their physical rehabilitation program. The Snap Dome WBI was co-invented by the PI in 1998 and patented by Rensselaer Polytechnic Institute in 2002 [Walczyk et al.,2002]. Teak Industries in currently negotiating an exclusive rights licensing agreement with RPI. The WBI device is not yet a commercially viable product.
The specific aims of this proposed 12-month STTR Phase I research project are to demonstrate the clinical efficacy of this product through a Phase I clinical trial at medical facilities in Albany, NY and Salem, NH. What will be demonstrated is: (1) how simple and inexpensive the Snap Dome WBI is to manufacture, (2) the easy integration of the WBI insert with various medical appliances that can be customized for each patient, (3) that the load transferred to the patient's limb is as expected, and (4) by using this product the mean number of days of hospital stay and rehabilitation can be reduced. If the Snap Dome WBI is shown to be effective, it will: -provide medical professionals (orthopedists, podiatrists, physical therapists) with an important, yet inexpensive tool to ensure that their patients comply with a prescribed physical rehabilitation program.-self-empower patients with an effective means to self-monitor their partial weight bearing status, and-drive down medical costs by reducing the occurrence of re-injury by a patient during rehabilitation. ? ?
