42-Week Follow up Study Shows Bioness L300 Foot Drop System Progressively Improves Walking in Stroke Survivors
Results Published in the Journal PM&R Demonstrate Long-Term Meaningful Benefits from L300, Greater Patient Satisfaction Over AFO
VALENCIA, Calif.--(BUSINESS WIRE)--Bioness, Inc. today announced that 42-week follow-up results from the company’s Functional Ambulation: Standard Treatment vs. Electrical Stimulation Therapy (FASTEST) trial of the Bioness L300® Foot Drop System have been published in the American Academy of Physical Medicine and Rehabilitation’s journal, PM&R. The study, titled “Response and Prediction of Improvement in Gait Speed from Functional Electrical Stimulation in Post-Stroke Drop Foot,” is an extension of the primary 30-week analysis demonstrating a similar impact with greater satisfaction when the L300® was compared to an ankle foot orthosis (AFO). Focusing on the participants randomized to the L300 group, the latest results published in PM&R demonstrate that persons with drop foot following stroke continued to show clinically meaningful and statically significant improvement in gait speed using the Bioness L300 up to 42 weeks.
“Following a stroke, it is commonly known that patients can reach a point at which the benefits of rehabilitation stall or are plateaued. This study clearly shows that with the Bioness L300, patients can experience increasing benefit over time”
“The long-term consequences of stroke, including limitations in mobility and walking, can be particularly isolating for patients. Often stroke survivors become dependent on others to complete self care and get around in the house and, especially, the community,” said Michael O’Dell, M.D., Chief of Clinical Rehabilitation Services, New York-Presbyterian/Weill Cornell Medical Center, and lead author on the paper. “This study demonstrates that subjects with stroke can achieve a meaningful improvement in their ambulation with functional electrical stimulation therapy, and that the changes can be sustained over time. Moreover, at 30 weeks the subjects in this study walked faster with and without the device, indicating a therapeutic effect occurred over time.”
As a whole, the group experienced an immediate increase of walking speed of 19% which continued to improve to 33.3% at 30 weeks as compared to baseline. This progressed to 45.0% improvement at the end of 42 weeks. “In addition to statistically important changes, we also looked carefully at practical, clinically important changes in ambulation as a result of the treatment.” said Dr. O ’Dell.
“Following a stroke, it is commonly known that patients can reach a point at which the benefits of rehabilitation stall or are plateaued. This study clearly shows that with the Bioness L300, patients can experience increasing benefit over time,” said Keith McBride, MPT, DPT, Vice President of Global Marketing and Product Development for Bioness. “These results demonstrate the ability of the Bioness L300 to help stroke patients achieve meaningful, long-term benefit, even years after their stroke.”
About the L300 Foot Drop System
The award winning L300 from Bioness, Inc. provides functional electrical stimulation to the muscles of the lower leg to help lift the foot up through wireless synchronization while walking. The L300 has been cleared by the FDA to improve gait in individuals with neurological impairments such as stroke, multiple sclerosis and spinal cord injury. The L300 is used as a primary medical device to address drop foot for individuals in the community and is also used for gait rehabilitation in inpatient or outpatient rehabilitation settings to potentially realize a variety of clinical benefits including improved mobility, maintaining or increasing range of motion, re-educating muscles, the prevention or slowing of muscle loss and increased local blood flow.
About Bioness Inc.
Bioness is the leading provider of innovative technologies to help people regain mobility and independence and improve quality of life. Neurological solutions for people suffering from hand and lower extremity paralysis include the L300® Foot Drop System, L300® Plus System, and the H200® Wireless Hand Rehabilitation System which utilize functional electrical stimulation (FES) to promote motor recovery and function for individuals affected by central nervous system disorders including stroke, multiple sclerosis, spinal cord injury, traumatic brain injury and cerebral palsy. Patients may also benefit from the Vector Gait and Safety System™, providing over-ground gait rehabilitation through dynamic body weight support. Bioness also distributes the Dynavision D2 which is a rehabilitative technology designed to help patients achieve new levels of physical independence and productivity. Individual results vary. Consult with a qualified physician to find out if these products are right for you. Additional information about Bioness can be found at www.bioness.com.
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