"The bionic lower leg system is able to match the intact human limb, allowing for greater walking efficiency and reduced stress on the rest of the body."
Personal bionics, originally funded by the U.S. Department of Veterans Affairs, is dramatically changing the life of amputees and reducing the complexity of their life care planning.
Throughout the course of United States history, significant research has been invested during wartime to advance technologies designed to improve the function of impaired or amputated limbs. These expenditures, their rationale and purpose should come as no surprise. Beginning with the more than 21,000 combat-related amputations suffered by the Union Army during the Civil War, traumatic limb loss has long plagued U.S. service men and women during wartime. As of 2011, the trend has persisted, with more than 1,100 combat-related major limb amputations reported during the U.S.'s conflicts in Iraq and Afghanistan.
Since 2003, the U.S. government has committed tens of millions of research dollars to visionaries, universities and manufacturers to ensure that our wounded soldiers receive the best technology available. These investments have resulted in the development and commercialization of personal bionics, a new class of technology that enables normal, natural, and more personalized movements for individuals with limb loss or impairments.
Personal bionics, originally funded by the U.S. Department of Veterans Affairs, is dramatically changing the life of amputees and reducing the complexity of their life care planning. The technology helps reduce the overall cost of care and enables people to return to work and other important daily activities faster and more easily than ever before.
The following examination will describe personal bionics in more detail and explain how this emerging technology needs to be part of the healthcare roadmap for all amputees.
This innovation began in the halls of the Massachusetts Institute of Technology. Hugh Herr, Ph.D. and director of biomechatronics at MIT, is a double amputee who lost both of his legs following a disastrous mountain climbing expedition on Mt. Washington in 1982. Since then, Dr. Herr has been on a lifelong quest to help others with limb pathology and to transcend the concept of disability for amputees across the country.
With funding provided by the U.S. Department of Veterans Affairs and the Army's Telemedicine and Advanced Technology Research Center (TATRC), Dr. Herr and his collaborators established the Powered Human Augmentation project and applied bionic technology to develop, in 2006, the first device that actually powers movement and enhances mobility.
The culmination of Dr. Herr's research, engineering and clinical testing is the BiOM Ankle System, the first personal bionic intervention that enables natural movement for lower-limb amputees. Today the BiOM is the only bionic ankle system that has been clinically shown to reach human normalization, allowing amputees to walk with a normal gait.
Personal bionic fittings first began in 2010 at facilities such as The Center for the Intrepid (CFI) at Brooke Army Medical Center. Here, Veterans were exposed to the BiOM for the first time and CFI officials released preliminary results from their fittings that indicated that the BiOM "allows leg amputees to walk at normal metabolic cost thus allowing an amputee to walk normally."
Dr.Jason Wilken, the Director of the Military Performance Laboratory at the CFI elaborated by stating that personal bionics offers promising results that indicate that "the bionic lower leg system is able to match the intact human limb, allowing for greater walking efficiency and reduced stress on the rest of the body."
Currently, the technology has already been adopted by more than 40 VA Medical Centers and the major Department of Defense sites across the country. As of June 2012, several hundred people with below-the-knee amputations currently wear the BiOM Ankle System, including William Gadsby, a 34-year-old veteran who wears both the BiOM ankle and a microprocessor knee. Gadsby, a former Marine who was severely injured by an IED while on patrol in Al Anbar Province, Iraq, notes immediate and significant improvements to his quality of life. "This device is literally a miracle," said Gadsby. "A few months ago I was walking at nighttime and had my hands in my pockets. For the first time in four years I was able to look up at the stars without stopping to balance myself. I've been able to walk up steep hills and stairs. I can walk down steep grades, and have been able to do some yoga stances. Just walking - in and of itself - is awesome."
The BiOM performance and instant improvement in function has similarly improved the health of many other veterans, both younger and older than Marine Gadsby. This includes Ed Lastowski, a Vietnam veteran who received 39 surgeries over the span of 30 years to try to preserve his natural leg following an accident overseas. Following elective surgery in 2010, Lastowski finally succumbed to amputation and struggled through an assortment of crutches, wheelchairs, and prosthetic devices. While these preserved his stability, they drastically limited his mobility, forcing extreme energy output and fatigue, and an altered gait cycle that led to persistent knee, hip, and back pain. Once fitted with the BiOM, Lastowski's life changed again, providing him with an experience unlike any conventional prosthesis. "The BiOM Ankle System isn't just another prosthetic. It is personal bionics. You have more energy, mobility, stability and less pain. I can walk normally now, which is something I hadn't done in three decades," Lastowski said.
The BiOM Ankle System is the first in a series of new personal bionics products that will emulate or augment physiological function through electromechanical replacement.
Personal Bionics is Changing the Standard of Care
Amputees using the previous standard of care - personal energy storing and returning (ESR) and passive-elastic prosthetics - face three clinical issues that challenge their return to work and daily activities:
They walk with an altered gait.
Traditional prosthetics are unresponsive. Without the triceps surae, it is up to the user to figure out how to move the device through the swing phase of the gait cycle. Altering the gait cycle to swing the leg accelerates wear on the joints and causes chronic knee, hip, and back pain. This often leads to an extended reliance on pain medications, osteoarthritis, and eventually joint replacement or even joint fusion.
They use more energy.
Prosthetics are heavy. It takes significant energy and effort to walk with a prosthetic device. As a result, people who wear the devices tend to walk more slowly and get tired quickly.
They feel unstable.
Prosthetic feet are fixed at a 90 degree angle. The ankle is also fixed and provides little or no flexion to roll with or adapt to the ground. People lose the sense that their feet are "feeling" the earth. It is estimated that people on prosthetics fall down about once every 10,000 steps.
Personal Bionics Simplifies Process
This new technology transcends the limitations of traditional prosthetics by delivering normalized function, which is defined as the ability to restore natural movement and personal mobility to individuals who wear prosthetics. True normalized function was impossible with previous prosthetic technologies.
Every BiOM customer is fitted using Personal Bionic Tuning, which compares their gait to a performance curve for non-amputees. While the person walks on the BiOM Ankle System, the clinician uses Android operating system technology to adjust the device to fit within the curve of normative gait characteristics for non-amputees. Once the person's gait is tuned to a natural level of performance, it is further adjusted to fit personal preference.
With traditional prosthetics, amputees experience persistent pain (see figure below). Studies have also been conducted through Veterans Administration Patient Treatment and Outpatient Care files that specifically link knee pain and symptomatic knee osteoarthritis - a "second disability" - to the Veteran amputee population when compared to non-amputees.
By normalizing function, personal bionics reduces aches and pains, relieves stress on the joints that is typically caused by deviations in the gait, increases stability, and enables people to return to work and other important daily activities faster and more easily than ever before.
Personal Bionics Comparative Effectiveness Research
The BiOM is already one of the most studied prosthetic devices on the market. Several publications have compared the performance of this technology with capabilities of traditional ESR and passive elastic prostheses designs. These studies demonstrate the BiOM's ability to resolve major clinical issues affecting amputee mobility by enabling:
The BiOM Ankle System instantly improves function, empowering amputees to do the things they want at their chosen speed. For Ed Lastowski, these benefits were critical: "My pain medication has been cut by a third since wearing the BiOM system. I no longer have the pain and pressure in my knee, shoulders, and hips."
Walking Tall with Personal Bionics
For veterans returning home from the trauma of war, living an active, healthy life is sometimes more of a dream than reality. Unemployment is higher among veterans than the rest of the population. According to the Associated Press, 45% of the 1.6 million Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) veterans are now filing for disability claims for service-related injuries, significantly more than for previous wars.
Personal bionics, such as iWalk's BiOM, provides an option that veterans have never had before - a solution that normalizes function, improves overall quality of life, and reduces the total lifetime cost of care.
Former Marine William Gadsby is one of a growing number of veterans with above-the-knee amputations who now walk naturally - just like before his injury - due to personal bionic technology. The personal bionic experience and powered plantar flexion capabilities make them feel more stable and secure on uneven terrain. "I recently took my family to the Outer Banks in North Carolina. I was able to walk up the sand dunes with no problem," Gadsby says, "In fact, I kept shouting to my wife and my 3-year-old son to keep up with me! I also went hiking in the Shenandoah Valley area of Virginia with a 50-pound pack. I was going up some pretty steep trails, and I wasn't getting tired."
Gadsby has recognized a huge change in his mindset as well. "I am a cranky guy normally," he admits. "But my wife has noticed a major psychological change in me. Before the BiOM, my body was more worn out with pain and I was always dead tired when going somewhere. Now I've got zero back pain. I'm active from the time I wake up until the time I fall asleep. My depression has largely receded. I'm more confident and feel closer to how I felt before I was wounded. I feel like a normal person again."
The promise and potential of personal bionics exceeds the expectations of even Dr. Hugh Herr. "I predict a bionics revolution," says Herr. "We're entering a bionic era where we actually are beginning to see technology that's sophisticated enough to emulate key physiological functions."
While Herr continues to set his sights on continued advancement and long-term personal bionics innovation, the health benefits and cost savings are already palpable for current providers of the BiOM, including the Department of Veteran's Affairs. According to Cezette Leopold, a VA prosthetics representative based at the VA medical center in Richmond, Virginia, "The real payoff is better health. Amputees outfitted with this technology will be healthier because they can lead much more active lives." And, Leopold adds, "Healthier amputees equate to a significant reduction in health care costs. Amputees who have less exhaustion and less pain tend to move around a lot more. They lose weight. They reduce their reliance on pain medications. They even return to work."
For the veterans and amputees around the country who have already received access to the BiOM, the revolution began with just a few simple, normal steps.
To learn more about transitioning veterans from prosthetics to personal bionics, visit: www.biom.com and www.va.gov
Author Disclosure: DRH is employed by iWalk, Inc.