Motor, on Mar 23 2008, 04:14 AM, said:
Hey guys,
I have just been invited to be part of a trial with a company called BIONESS Inc. Has any heard of them.. They want to use a product called the NESS 300L foot drop system. Its used instead of AFOs & KFAOs. Tried it once and it made it easier to pull my feet through while walking with a walker. Its actually pretty neat invention. Just wondering if anyone has heard of it or used it. So far it only for in therapy use. Rather pricey so doubt insurance will cover it and its also new so who knows. Ok all...be well~!
Thanks
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Hi Motor,
I have heard of the Bioness system before. It was originally used with individuals after a CVA (Stroke) and then has had apparent success, so much so that it is being suggested for those with MS and SCI/D. I think the reason that it is "in-therapy" only is due in part to the fact that it is still in trials. Insurance companies apparently need "evidence of result" from those trials.
However, as mentioned above, over the last month, there has been reported success, in trials with the BIONESS system.
Bioness reports breakthrough in foot drop treatment
Bioness has reported encouraging results from a 12-month study which showed that extended use of the NESS L300 Foot Drop System produced improvements in overall walking ability among stroke and traumatic brain injury survivors.
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 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.
The positive gains with the L300 is said to 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.
Alon, associate professor at the University of Maryland School of Medicine, said: "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 found
at the Datamonitor
and
New Clinical Evidence Shows Treatment Breakthrough for Foot Drop in Chronic Stroke...
Thu Feb 21, 2008 3:36pm EST Email | Print | Share | Reprints | Single Page| Recommend (-)
New Clinical Evidence Shows Treatment Breakthrough for Foot Drop in Chronic Stroke and Traumatic Brain Injury Survivors
VALENCIA, Calif.--(Business Wire)--
Bioness Inc. announced that research findings presented today 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
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
Schwartz Communications
Thea Lavin, 415-512-0770
Erin Walsh, 781-684-0700
bioness@schwartz-pr.com
Copyright Business Wire 2008
found
at Reuters
I hope that this helps! Good luck with the 'trials'.
take care,
K