University of Pittsburgh Researchers Conclude Phase II Clinical Trials of Advanced Mobility System for People with Disabilities
PITTSBURGH, November 25, 2002 — A panel of experts has recently recommended to the U.S. Food and Drug Administration the approval of a new wheelchair that enables users to operate on two wheels, allowing them to better negotiate obstacles like stairs and uneven pavement. Research conducted at the University of Pittsburgh's School of Health and Rehabilitation Sciences (SHRS), in cooperation with Independence Technology, a Johnson & Johnson company, contributed to the panels recommendation.
"This device has the potential to significantly improve mobility for many of the two million Americans who use wheelchairs," said Rory Cooper, Ph.D., professor and chair of the department of rehabilitation science and technology, SHRS and co-principal investigator of the trial. "We at the University of Pittsburgh School of Health and Rehabilitation Sciences are proud that, through our research, we are able to play a part in the development of such revolutionary technology."
Researchers at SHRS completed the second phase of a clinical trial that tested the investigational advanced mobility device known as the INDEPENDENCE™ IBOT™. The IBOT is an advanced gyro-balanced system that is designed to operate on four wheels or two wheels, stabilizing the user by instantly and automatically adjusting and balancing itself. In its two-wheel position, it allows a seated user to move about at standing eye-level. Its rotating four-wheel base allows the user to climb over street curbs and travel over uneven and hilly terrain, such as grass, sand and rocky pathways.
"The development and pending approval of this device marks a remarkable advancement for people with mobility impairments," said Michael Boninger, M.D., director of University of Pittsburgh Medical Center's (UPMC) Center for Assistive Technology (CAT), and co-principal investigator of the trial. "For the first time, people who use wheelchairs will be able to do things they never thought possible."
Phase two of the clinical trial consisted of 14 study subjects - 10 unimpaired non-wheelchair users and four expert wheelchair users, all of who tested the device in their own homes and throughout their daily routine for three days and one week, respectively.
Powered by a rechargeable battery that can operate up to a full day on a single charge, the wheelchair uses an integrated system of electronic, sensor and software components to automatically adjust itself according to the seat's movement and the user's center of gravity. These components are accompanied by a backup system to assure the safety of the user. It was invented by Dean Kamen, founder of DEKA Research and Development Corporation, Manchester, N.H. Johnson & Johnson has been partnering with Kamen over the past six years to develop the IBOT for FDA approval.
For more information on the University of Pittsburgh's School of Health and Rehabilitation Sciences, please access http://www.shrs.pitt.edu.