May 20, 2009 – Ultraflex, the sole leader in orthotic adjustable dynamic response technology, announced today the launch of the UltraSafeGait™ pediatric ADR-AFO. The pediatric version is now available in markets around the world including the United States, Europe, Canada, Australia, and Japan. The UltraSafeGait™ Adjustable Dynamic Response ADR-AFO pediatric version now completes the adjustable dynamic response product line which also includes the adult versions, UltraSafeStep™ ADR-AFO, ADR-KAFO, and the convertible ADRKAFO/AFO with the Ultraflex UltraQuickRelease™.

Ultraflex’s exclusive adjustable dynamic response technology is designed for managing gait dysfunction. Ultraflex ADR addresses the limitations of conventional orthoses, including the limitations associated with solid AFOs, hinged AFOs, carbon dynamic, ground reaction AFOs, DAAJs, and stance control orthoses (SCOs). This breakthrough technology eliminates limitations associated with conventional orthoses by providing customized treatment of deficits resulting in a more biomechanically normal gait. The technology presents compensating orthotic intervention for each phase of the gait cycle. With Ultraflex’s ADR, unprecedented stability and motion is now available to the developing child with challenging neurological presentations such as cerebral palsy. Adult patients in the acute and chronic phases of neurological recovery with conditions such as post-stroke and post-polio have been benefiting from the technology since January 2004.

“This is a welcome development from Ultraflex, a company with a well-earned reputation for innovation, most notably in the area of precise dynamic stimulus bracing as a conservative intervention for spasticity management,” said Keith M. Smith, CO, LO, FAAOP. The UltraSafeGait™ Adjustable Dynamic Response ADR-AFO pediatric version complements Ultraflex’s pediatric therapeutic line of stretching braces which are designed to increase muscle length for the growing child with spasticity. Children with movement and posture disorders can now fully benefit from the gains in muscle length achieved with Ultraflex therapeutic bracing while ambulating with UltraSafeGait™. This is made possible because unlike conventional orthoses, UltraSafeGait™ provides for a patient-specific, optimal functioning gait.

UltraSafeGait™ Adjustable Dynamic Response technology provides a sought after orthotic solution for the heretofore unmet orthotic needs of children with crouch gait types, equinus gait types, and all of their variants. This revolutionary technology provides patients with natural range of motion (ROM) that is stabilized, thereby limiting the compromises often associated with conventional orthoses. UltraSafeGait™ Adjustable Dynamic Response technology provides adjustable muscle augmentation, stability in stance, smooth/natural rollover, and clearance in swing, making Ultraflex’s technology unparalleled.

“UltraSafeGait™ for children and UltraSafeStep™ for adults Adjustable Dynamic Response (ADR) technology is the result of nearly two decades of collaboration, research, and longstanding associations with multidisciplinary professionals in the field of movement and posture disorders, gait analysis, and physical rehabilitation,” said Mark D. DeHarde, President and founder of Ultraflex Systems, Inc. Ultraflex technologies uniquely address the rehabilitation challenges associated with preserving and restoring movement, posture, balance, and strength. “The rehabilitation team’s clinical assessment values and treatment goals drive our individual brace design, making the individualized orthotic intervention truly a patient inspired solution,” DeHarde further stated.

The introduction of UltraSafeGait™ coincides with the 2009 Annual Meeting of The Association of Children''''s Prosthetic-Orthotic Clinics in Tempe, Arizona.

Previous studies have shown low end-user acceptance of a hip disarticulation style prosthesis and that the limitations of such prostheses, including poor gait pattern, socket discomfort, weight of the prosthesis, loss of mobility, instability and high energy consumption are a contributing factor.

This study was initiated to determine if a new style of prosthetic hip joint could help to overcome some of the limitations concerning the gait pattern. The present study analyzed the gait pattern of six hip disarticulation amputee subjects. The objective was to compare two different prosthetic hip joints, both from Otto Bock HealthCare: The new Helix(3D) and the 7E7, which is based on the Canadian model proposed by McLaurin (1954). Kinematics and kinetics were recorded by an optoelectronic camera system with six CCD cameras and two force plates.

During weight acceptance, the Helix(3D) extends considerably slower and reaches full extension later than the 7E7. The increased range of pelvic tilt observed with hip disarticulation amputees is significantly reduced (by 5 +/- 3 degrees) when using the Helix(3D) Hip Joint.

In addition, this system showed increased stance phase knee joint flexion as well as increased maximum swing phase knee flexion angles compared to the 7E7. These motion analysis results show that the Helix(3D) Hip Joint can reduce gait abnormalities compared to the uniplanar design of the 7E7 hip joint.

Barack Obama’s recess appointment of Dr. Donald Berwick as head of the Center for Medicare and Medicaid Services (CMS) marks a new low in his destructive presidency, and that is saying something!

After forcing the Orwellian Patient Protection and Affordable Care Act (PPACA) onto an unwilling populace and through a reluctant Congress, he installs an elitist who admits to being “in love” with Britain’s National Health Service into a position of incredible power without so much as a hearing.

This is an affront to the American people, and to Constitutional government. It also completely confirms our predictions regarding the true nature of ObamaCare. It will be modeled after the NHS with rigid budgets, income redistribution, command-and-control structure, “death panels” (The National Institute for Clinical Excellence, or NICE), and a weighty bureaucracy. Ironically, this comes at a time when the British are struggling with the bureaucratic morass of the NHS authority.

How does Dr. Berwick hope to control the billions of decisions made by practicing physicians every day? Daniel Henniger, in his Wonder Land column, has some revealing, and frightening, quotations:

"The unaided human mind, and the acts of the individual, cannot assure excellence. Health care is a system, and its performance is a systemic property."

"I would place a commitment to excellence—standardization to the best-known method—above clinician autonomy as a rule for care."

"Young doctors and nurses should emerge from training understanding the values of standardization and the risks of too great an emphasis on individual autonomy."

The mechanisms for this are already in place. A central board, our version of the NICE, was already legislated into existence by the stimulus bill. Payment-for-performance (P4P) is already being used in certain areas to enforce compliance with clinical practice guidelines. Language in PPACA gives the secretary of Health and Human Services (which oversees CMS) authority to bar from participation doctors who do not comply with certain quality standards, i.e. conform to guidelines. Physicians are currently being bribed by CMS to purchase electronic health records, which will be used to insert algorithms to “guide” the physician to the “correct” plan of care. Where do practice guidelines come from?

Practice guidelines are a recent fad and have proliferated to cover virtually all areas of medicine. They are funded either by government, insurance and pharmaceutical cartels, or medical organizations such as the American Medical Association. While billed as “evidence-based,” for the most part they are consensus opinions of a panel of “experts.” These experts invariably have extensive financial ties to industry. This may explain why practice guidelines are almost always biased towards greater levels of drug treatment targeting ever-wider patient populations.

Guidelines are sluggishly produced and often superseded by new information when finally published. As an example, tight control of blood sugar has been pushed by guidelines for Type II diabetes for years. Four studies published in 2008 showed either no benefit or increased death rates with this approach. Guidelines discourage innovative thinking and encourage the “one-size-fits-all” approach so loved by Dr. Berwick. If practice guidelines were in existence in the 18th century, bloodletting might still be the standard of care!

The problem with trying to implement guidelines as public policy is that we are all unique individuals and individual differences really do matter. Only a personal physician has the local knowledge of the patient that permits tailoring of treatment for maximum benefit at lowest risk.

Central control of medical care, which is the predictable endpoint of centralized payment for care, will wreak havoc on the medical profession and harm thousands, if not millions, of patients. Since PPACA effectively nationalizes the private health insurance industry, the Berwick appointment affects everyone.

Patients need to seize control of their medical destinies by setting up Health Savings Accounts and paying for their medical care themselves. Seniors should strongly consider opting out of Medicare Part B. For doctors, it has never been more urgent to sign the Physicians’ Declaration of Independence and sever third party relationships. The future of an independent medical profession is at stake.

Trace, Trim and Walk Away!

It’s easy to assume that medical professionals are the ones in the driver’s seat when it comes to healthcare management.  However, patients are in a unique position to take control over their plans.  Here are some ways individuals can be pro-active:

• Write questions and concerns down prior to medical office visits and make sure that all points are reviewed.  Writing down the answers to questions is just as important as writing down the questions.
   
• Don’t be shy.  Medical professionals are talented, but they aren’t mind readers. Often times, they are relying on feedback from the patient.  
   
• Specify.  If something hurts, describe the pain and try to pinpoint exactly where it’s felt.
   
• Track issues.  For example, the swelling of a residual limb may be connected to medication, diet, weather, or activities.  
   
• Take responsibility.  Some things may be out of a patient’s control, but many lifestyle choices have a direct affect on health and quality of life.
   
• Confront issues.  If a medical professional isn’t using his or her ‘listening ears’, a reality check may be in order.  Second opinions are always an option, but medical professionals should always be given a realistic opportunity to rectify issues.
•   
• Be compliant.  Don’t missva medical appointment if you don’t have a good reason to do so.  Take medical advice seriously.
   
• Remember you are a person, not a number.  It’s easy for some medical professionals to forget they are treating the person, not the body part.  A bad personality clash between a patient and a medical professional can mean it’s time to move on.  On the flip side, some technically brilliant medical professionals just have lousy bedside manners.  If the priority is surgical brilliance, not informal chit-chat, maybe the bedside manners can be overlooked.  That’s a personal call that only the patient can make.

hanks to a small cuff around her leg, Bonnie Bell can walk in the mall without falling. In fact, Bell, who was diagnosed with multiple sclerosis in 1998, has not so much as tripped since she began using the Ness L300 five months ago.

Almost two-thirds of all people living with MS report that trouble walking takes the biggest toll on their quality of life1 and one of the leading causes of difficulty walking is foot drop, a weakness or paralysis of the muscles that lift the front of the foot. People with foot drop often drag their foot and hike their hip to take a step, causing long-term damage to muscles and even bones and making walking miserable.

A recent advance in the field of neurostimulation is offering a new approach. Functional electrical stimulation or FES technology uses low levels of electrical current to stimulate nerves in the extremi- ties. My patients often say that FES therapies create a light tingling sensation as electrical impulses activate specific muscles. FES is not a cure for the damage caused by
see you for only a few minutes in a setting that doesn’t reflect your typical daily activities. For some people, foot drop is only present after sustained exertion. Let your provider know about all the dif- ficulties you experience when walking.

The foot drop diagnosis
Before investigating a FES device, it is critical to obtain an accurate diagnosis. Walking problems may be caused by other conditions.
In order to determine if foot drop is present, make sure your health-care team is aware of all the mobility challenges you face. A busy physician may see you for only a few minutes in a setting that doesn’t reflect your typical daily activities. For some people, foot drop is only present after sustained exertion. Let your provider know about all the dif- ficulties you experience when walking.

Therapeutic options
In the past, the treatment for foot drop was a rigid plastic ankle-foot orthosis (AFO) worn around the leg. Many different varieties of AFO are available and they are effective, but patients using them may experience discomfort, trouble getting the brace into a shoe, and even muscle atrophy as the AFO limits motion.

A new alternative is an FES device, which can be used independently after the patient has worked with a physical therapist. At present there are two devices on the market. Both are FDA approved, and both stimulate the peroneal nerve which, in turn, signals under-active muscles in the leg to raise the foot at the appropriate time during the step cycle.

NESS L300
 The NESS L300TM Foot Drop System is worn in two parts—a small transmitter in the shoe and a device fitted below the knee. For more info: bioness.com.

WalkAide
 The WalkAide consists of a battery-operated, single- channel electrical stimulator, two electrodes and electrode leads. For more info: walkaide.com.

A case in point
James has the typical mobility challenges that I frequently see in my MS patients at Shepherd. His work requires business trips with a lot of walking, especially at airports. At the end of his working day, James would drag the toes on his right foot and often fell. He was prescribed an ankle-foot orthosis, but rarely used it because he said it was uncomfortable.
At Shepherd, James was given an FES device for the foot drop on his right side. James reported that he did not fatigue as easily, was moving faster and had not fallen since using the device.

Insurance coverage
To date, neither the WalkAide nor the NESS L300 is covered by Medicare except under certain diag- nostic codes for incomplete spinal cord injury. Some private insurance does cover the devices on a case-by-case basis. I advise my patients to ask their FES device manufacturer for information about trial rental programs and third-party financing options.

Ideally, FES therapy should begin during out-patient rehabilitation and be covered by insurance. Patients should use FES devices during six to eight follow-up therapy visits in order to learn how to properly operate and maintain the device. Therapy should be followed by a home trial period and ulti- mately purchased if benefits are experienced.

When FES does not work
FES offers great potential for lessening the effects of foot drop, but it will not be the answer for every- one. Working with a physical therapist, each person can determine the best individual plan of action for improving mobility. That plan might include an AFO or FES device, strengthening and stretch- ing exercises, or using equipment like a cane or a walker. Even if FES is not a good option in your situation, there are other ways
to help you keep moving while living with MS.

Ben Thrower, MD, is the medical director of the Andrew C. Carlos MS Institute at Shepherd Center, Atlanta, Ga.

Momentum • Summer.2010