Hanger Orthopedic Group, Inc. has completed enrollment for the INSTRIDE investigational device exemption clinical trial studying the effectiveness of its WalkAide System in the rehabilitation of stroke victims, according to a company press release.
The study will compare the use of the WalkAide, a wireless electrical stimulation device worn on the ankle, with a standard ankle-foot orthosis used to treat foot drop in patients who have suffered a stroke. The trial will include 496 patients at 30 institutions across the US. After 6 months, the researchers will compare the results of the two devices based on subject’s ambulation and ability to complete daily tasks.
The results of the trials will be used to form the basis for submission to the Centers for Medicare and Medicaid in 2013 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,” Francois Bethoux, MD, director of rehabilitation services at the Cleveland Clinic Mellen Center and the principal investigator of the INSTRIDE clinical trial, stated in the release. “Walking limitations have a profound impact on people’s everyday lives, and it is important for patients to have options for active devices that improve walking ability and potentially promote brain plasticity.”