This is the reason we need independent research projects. Comparing their estim foot drop product against the standard AFO doesn't answer the real question. What is the most effective foot drop therapy? You have all these other possibilities.
But wait, only your doctor/physical therapist can tell you about this stuff, I'm certainly not qualified.
Walkaide
Bioness L300
XFT-2001
ActiGait
PACE
freeStep
STIMuSTEP
300PV FES
or these
1. Soft brace - http://www.3tailer.com/shop/freedomandreg-soft-footdrop-brace
2.. Musmate a strapping and bungee sytem - http://www.musmate.com/
3. x-strap a bungee sytem from the ankle - http://www.x-strap.com/
4. Malleoloc Ankle Brace - http://www.achillesmed.com/Malleoloc_Ankle_Brace.html?gclid=CJyWoMu3kKACFQsNDQod12P0dw
5. surgery
6. AFO hinged or fixed
or do nothing which is what your insurance will pay for.
http://www.sacbee.com/2012/05/02/4460611/hanger-completes-enrollment-of.html
Hanger Orthopedic Group, Inc. (NYSE: HGR) today announced the
completion of enrollment in its pivotal INSTRIDE investigational device
exemption (IDE) clinical trial studying the effectiveness of its
WalkAide System in the rehabilitation of stroke survivors. With 496
patients enrolled at 30 institutions in the United States, the INSTRIDE
trial is the largest, randomized, controlled study of a walking device
ever conducted in stroke rehabilitation.
"We are pleased to reach
this significant milestone on schedule and exactly two years to the day
of enrollment of our first patient," said Hanger CEO Thomas F. Kirk,
Ph.D. "We greatly appreciate the dedicated efforts of our physician
investigators and their research staff. We are one step closer to
bringing the WalkAide technology to those who need it most."
Addressing
a frequent consequence of hemiplegia from stroke known as "foot drop",
the purpose of the INSTRIDE trial is to compare the use of the WalkAide,
a functional electrical stimulation (FES) device, with the standard of
care ankle-foot orthosis (AFO), a rigid plastic brace designed to
stabilize a paralyzed or weakened foot in a functional position. Primary
outcome measures include ambulation (more specifically to gait
velocity) and activities of daily living, with the main study endpoint
as the comparison of success between the two devices at six months. The
results of the INSTRIDE trial will form the basis for submission in 2013
to the Centers for Medicare and Medicaid Services (CMS) 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," said Francois Bethoux, M.D., Director of
Rehabilitation Services at the Cleveland Clinic Mellen Center and the
principal investigator of the INSTRIDE clinical trial. "We are very
happy to have achieved this enrollment milestone and are thankful for
the patients who kindly agreed to participate. Walking limitations have a
profound impact on people's everyday lives. It is important for
patients to have options for active devices that improve walking ability
and potentially promote brain plasticity."
Granted 510(k) clearance by the U.S Food and Drug Administration (FDA) in 2005 and a CE Mark from the European Union
in 2006, the WalkAide is an external stimulator that applies electrical
pulses to restore proper foot flexion for patients who have suffered an
upper motor neuron disruption from a stroke, incomplete spinal cord
injury, traumatic brain injury,
multiple sclerosis, or cerebral palsy. The device functions by using a
microprocessor with a built-in tilt sensor that allows for precise
timing of stimulus to create a normalized gait pattern. About the size
of a deck of cards, the device fits on a small cuff worn around the
calf; it has no external wires and can be worn with or without shoes.
Developed and commercialized by Hanger's therapeutic solutions business
unit Innovative Neurotronics, Inc., the WalkAide is currently being used
by thousands of patients worldwide.
About Hanger – Hanger
Orthopedic Group, Inc., headquartered in Austin, Texas, is the world's
premier provider for services and products that enhance human physical
capability. Hanger provides orthotic and prosthetic patient care
services, distributes O&P devices and components and provides
therapeutic solutions to the broader post-acute market. Hanger is the
largest owner and operator of orthotic and prosthetic patient care
centers with in excess of 700 O&P patient care centers located in 45
states and the District of Columbia.
Hanger, through its subsidiary Southern Prosthetic Supply, Inc, is also
the largest distributor of branded and private label O&P devices
and components in the United States. Hanger provides therapeutic
solutions through its subsidiaries Innovative Neurotronics and
Accelerated Care Plus. Innovative Neurotronics introduces emerging
neuromuscular technologies developed through independent research in a
collaborative effort with industry suppliers worldwide. Accelerated
Care Plus is a developer of specialized rehabilitation technologies and
the nation's leading provider of evidence-based clinical programs for
post-acute rehabilitation serving more than 4,000 long-term care
facilities and other sub-acute rehabilitation providers throughout the
U.S. For more information on Hanger, visit www.hanger.com and follow us at www.Facebook.com/HangerNews and www.Twitter.com/HangerNews.
Contacts: Jennifer Bittner, (904) 249-4210; jbittner@hanger.com Thomas Hofmeister, 512-777-3800, thofmeister@hanger.com
Use the labels in the right column to find what you want. Or you can go thru them one by one, there are only 29,116 posts. Searching is done in the search box in upper left corner. I blog on anything to do with stroke.DO NOT DO ANYTHING SUGGESTED HERE AS I AM NOT MEDICALLY TRAINED, YOUR DOCTOR IS, LISTEN TO THEM. BUT I BET THEY DON'T KNOW HOW TO GET YOU 100% RECOVERED. I DON'T EITHER, BUT HAVE PLENTY OF QUESTIONS FOR YOUR DOCTOR TO ANSWER.
Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.
What this blog is for:
My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.
Thursday, May 3, 2012
Hanger completes enrollment of WalkAide INSTRIDE clinical trial
Labels:
AFO,
clinical trials,
doctor question,
foot drop,
rants,
walking
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