Hanger, Austin, Texas, announced the completion of enrollment in its pivotal INSTRIDE investigational device exemption (IDE) clinical trial studying the effectiveness of the Innovative Neurotronics WalkAide System in the rehabilitation of stroke survivors. With 496 patients enrolled at 30 institutions in the United States, the INSTRIDE trial is the largest, randomized, controlled study of a walking device ever conducted in stroke rehabilitation.
“We are pleased to reach this significant milestone on schedule and exactly two years to the day of enrollment of our first patient,” said Hanger CEO Thomas F. Kirk, PhD. “We greatly appreciate the dedicated efforts of our physician investigators and their research staff.”
The purpose of the INSTRIDE trial is to compare the use of the WalkAide functional electrical stimulation (FES) device with an AFO for foot drop as a consequence of post-stroke hemiplegia. Primary outcome measures include ambulation (more specifically to gait velocity) and activities of daily living (ADL), with the main study endpoint as the comparison of success between the two devices at six months. The results of the INSTRIDE trial will form the basis for submission in 2013 to the Centers for Medicare & Medicaid Services (CMS) for national coverage of the WalkAide.
“The INSTRIDE clinical trial is a one-of-a-kind endeavor that could facilitate reimbursement of this technology and set the model for additional studies to come,” said Francois Bethoux, MD, director of rehabilitation services at the Cleveland Clinic Mellen Center, Ohio, and the principal investigator of the INSTRIDE clinical trial. “We are very happy to have achieved this enrollment milestone and are thankful for the patients who kindly agreed to participate. Walking limitations have a profound impact on people’s everyday lives. It is important for patients to have options for active devices that improve walking ability and potentially promote brain plasticity.”
The WalkAide was granted 510(k) clearance by the U.S Food and Drug Administration (FDA) in 2005 and a CE Mark from the European Union in 2006.
