New study challenges current treatment paradigms for stroke survivors, suggests use of medical device can maximize patient recovery potential 

5/24/2006 

Bethesda, MD - Imagine being 17-years-old and finding yourself in the hospital, unable to speak, with the left side of your body completely paralyzed. You're a healthy, young high school athlete who simply collapsed on the court during basketball practice. This is what happened to Gerald Gordey 40 years ago. And he's been battling the debilitating effects of his stroke ever since.

One in seven Americans will suffer a stroke. Stroke is the No. 1 cause of serious disability in adults in the United States, according to a recent report by the National Institute of Neurological Disorders and Stroke at the NIH. Like Gordey, many stroke survivors face months of rehabilitation and a lifetime of pain and paralysis. The Centers for Disease Control reports more than 1,100,000 American adults experience difficulty performing everyday activities as a result of a stroke.

Now, a new study accepted for press in the peer-reviewed journal Neurorehabilitation and Neural Repair challenges the way we've been rehabilitating stroke survivors for years. The study identifies a trend that suggests traditional rehabilitation is stopped before patients have reached their full potential for recovery. It also suggests that a new medical device, called the WalkAide®, can reveal hidden potential for additional patient recovery.

Traditional programs discharge patients three months post-stroke, as it is generally accepted that a stroke survivor's potential for recovery plateaus around the twelve week mark. This leaves little hope for additional improvement after that time.

This recent study examines the potential for improvement when the WalkAide is used for one full year, specifically by patients who experience a form of paralysis known as "foot drop" that significantly hinders the patient's ability to walk normally. The results are encouraging.

At the traditional three month mark, when rehabilitation is typically stopped, the walking speed of patients wearing the WalkAide increased by 15%. However, with continued usage of the WalkAide system through six months, the patients' walking speed increased by 32%. Even more encouraging, after twelve months, the patients' walking speed had increased by nearly 50%. The study also showed the number of steps taken per day by WalkAide users increased significantly over the year. Patients suffering from foot drop due to spinal cord injury, traumatic brain injury, and other pathologies such as multiple sclerosis and cerebral palsy were included in the study and also experienced the same positive results.

"What we're seeing here is hope for a more functional recovery from stroke," said Conrad Kufta, MD, board certified neurosurgeon and former Senior Staff Neurosurgeon in the Surgical Neurology Branch of the NIH. "Previously, the belief was that once a certain time elapsed, further recovery was minimal at best. There wasn't much opportunity for the patient to advance further. With the WalkAide, patients like Gerald, who suffered a stroke over 40 years ago, regain mobility that was believed to be permanently lost after his brain attack. This is very promising news for stroke survivors with foot drop."

Cleared for marketing by the FDA in September 2005, the WalkAide system by Bethesda-based Innovative Neurotronics, Inc. combats foot drop by applying low level electrical currents directly to a motor nerve in the leg which instructs the muscle to flex the foot so the patient can walk normally. Contrary to traditional therapies that require the patient to spend hours in hospitals or rehabilitation facilities, the WalkAide is small, portable, and easily operated by the patient. Worn around the leg, just below the knee, the AA battery-operated device is about the size of a deck of cards.

"This is the most exciting innovation in orthotics since the introduction of advanced moldable plastic technology in the 1970s," said Deanna Fish, Certified Prosthetist/Orthotist (CPO) and Director of Clinical Support for Innovative Neurotronics. "With the WalkAide, we'll be able to help people in ways we've never been able to before."

The now 57-year-old Gordey is one of the first patients in the world to wear the device. And he couldn't be more pleased with the results. "The beneficial effects of the WalkAide were immediate," Gordey said. "I could walk with less difficulty. I wasn't dragging my foot or tripping over my toe. Muscles I hadn't used in years began to give off that nice sore feeling you get after going for a run for the first time in awhile."

While the initial study provided encouraging results and patients like Gordey offer positive testimony, the WalkAide developers at Innovative Neurotronics are interested in uncovering even more evidence of the device's efficacy and the need for extended treatment paradigms. Full scale, statistically significant clinical trials are underway in the United States to further examine the WalkAide's ability to strengthen cortico-spinal pathways and retrain damaged communication channels between the brain and the leg.

Media Note: Professional Beta SP Cam b-roll available. High resolution photographs and press kit available for download at: http://www.ininc.us/newsevents/forthepress.html.

About Innovative Neurotronics, Inc.:

Specializing in the field of functional electrical stimulation, Innovative Neurotronics, Inc. identifies emerging Myo-Orthotics Technologies® developed at research centers and universities throughout the world that use neuromuscular stimulation to improve the functionality of an impaired limb. Innovative Neurotronics, Inc. is a wholly owned subsidiary of Hanger Orthopedic Group, Inc. (NYSE:HGR), the world's largest provider of orthotic and prosthetic (O&P) patient care. Headquartered in Bethesda, Maryland, Hanger owns and operates 624 patient care centers in 46 states including the District of Columbia, with 3,290 employees including 1,021 practitioners (as of 12/31/05). For more information on Innovative Neurotronics, Inc, visit www.ininc.us. For more information on Hanger, visit www.hanger.com.

Certain statements included in this press release are forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Please refer to the Company's SEC filings for factors that could cause actual results to differ materially from the Company's expectations

Contact Info
Jennifer Bittner
301-280-4869
jbittner@hanger.com

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