New Clinical Evidence Shows Treatment Breakthrough For Foot Drop In Chronic Stroke And Traumatic Brain Injury Survivors

Main Category: Medical Devices / Diagnostics
Also Included In: Neurology / Neuroscience;  Stroke
Article Date: 25 Feb 2008 - 2:00 PDT

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Bioness Inc. announced that research findings presented at the American Stroke Association's International Stroke Conference 2008 in New Orleans, LA showed that extended use of the NESS L300™ Foot Drop System produced improvements in overall walking ability among stroke and traumatic brain injury survivors in a recently concluded 12-month study.

Foot drop is a partial leg paralysis that prevents the foot from lifting - causing instability and difficulty walking in persons suffering from conditions such as stroke, traumatic brain injury, multiple sclerosis, cerebral palsy and incomplete spinal cord injuries. Prior to the availability of the NESS L300, patients typically relied on rigid plastic braces that restrict ankle movement and sometimes lead to additional problems.

The study served as a one-year follow-up assessment on patient outcomes from a NESS L300 study published last month in the American Journal of Physical Medicine and Rehabilitation. The new findings were presented by Dr. Gad Alon, Associate Professor at the University of Maryland School of Medicine. The pooled-patient data revealed that daily use of the NESS L300 neuroprosthesis over a 12-month period enabled patients experiencing chronic hemiparesis and foot drop following stroke or traumatic brain injury to significantly improve their walking abilities.

"The NESS L300 offers a substantial improvement over traditional therapy and may significantly enhance a person's ability to walk at an increased speed with improved stability to produce a more normal overall gait pattern," said Dr. Alon. "I'm encouraged by the findings that demonstrate the clinical benefits with short-term use of the L300 as well as ongoing improvements with continued use over time, as evidenced by the 12-month study."

The study was designed to follow patients with foot drop who were at least six months post-stroke or traumatic brain injury. Evaluations of their gait with the NESS L300 were conducted in four testing sessions: at baseline (with and without the NESS L300), and then after one month, two months and one year.

Each testing session measured the study participants on common gait indicators: walking speed, single limb stance, gait symmetry and stride time. Participants were measured with special calibrated insoles that recorded their actions during a 6 minute walking test and a 10 meter walk over an obstacle course.

The positive gains with the L300 demonstrate a breakthrough in the treatment of foot drop because all of the subjects in the study were in the "chronic" stage of recovery where significant improvement is traditionally considered limited. The findings of the long term follow-up study are encouraging for many patients who experience foot drop as a result of stroke, traumatic brain injury and other neurological disorders.

"The feedback from patients learning to walk again and the professional community has been enormous and overwhelmingly positive," said Yitzhak Zilberman, CEO, Bioness Inc. "The NESS L300 has the potential to improve the quality of life for millions of individuals worldwide."

The NESS L300 Foot Drop System integrates state-of-the-art electronics into a compact, wireless design. Sensors in the system detect whether the patient's foot is in the air or on the ground and communicate wirelessly to a microprocessor placed just below the knee. As the patient walks, low-level stimulation is sent to the underlying nerves and muscles that control the lifting of the foot.

Individual results vary. People should consult with a qualified physician to determine if the NESS L300 is right for them.

About Bioness Inc.

Bioness develops, manufactures and markets innovative neuromodulation products that aid individuals in the recovery from central nervous system disorders such as stroke, multiple sclerosis, spinal cord injury, traumatic brain injury and other neurological disorders.

The NESS L300 Foot Drop System and the NESS H200® Hand Rehabilitation System, cleared for use by the Food and Drug Administration (FDA) and approved by the European Union (CE Mark), are designed to enable patients to achieve new levels of physical independence and productivity.

Additional information about Bioness can be found at http://www.bioness.com.

NESS®, NESS L300™, NESS H200®, Intelli-Gait™ and Intelli-Sense Gait Sensor™ are trademarks of N.E.S.S. Neuromuscular Electrical Stimulation Systems, Ltd., Ra'anana, Israel | Manufacturer: Bioness Inc.| Bioness®, the Bioness Logo® and LiveOn™ are trademarks of Bioness Inc., Valencia, CA | Rx only

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