Fall Risk: A Dearth of Real-world Evidence

[caption id="attachment_237446" align="aligncenter" width="600"] Prot/stock.adobe.com[/caption] Most of Taavy Miller’s patients who use a lower-limb prosthesis have experienced a fall at least once, often early in their rehabilitation or while still in the hospital. She recalls one of her patients who was doing well during his recovery and rehabilitation. After being cleared for a prosthesis from his physician, he fell while getting out of bed a few days later, and the skin on his residual limb tore open. “An injury such as this not only required a doctor’s visit for him, but it also delayed his healing and getting his first socket,” says Miller, PhD, CPO, who is a research scientist with the Hanger Institute for Clinical Research and Education. “It is difficult for our patients who may already have difficulty with healing to have a setback such as a fall.” “Luckily he healed,” she says. “He was able to get his first prosthesis, and work on regaining his joint mobility, strength, and confidence.” Falls are common and can be a costly concern for individuals with lower-limb amputations. At present, there are few models that O&P clinicians can use to predict the incidence of future falls for this population. We spoke with several experts about identifying factors that increase fall risk and working with patients on strategies to reduce injurious falls, as well as careful prosthetic selection and fitting. A Physical Therapist’s POV Over the past few years more research has been published addressing the issue of falls in people with lower-limb amputations, says Sheila Clemens, PhD, MPT, PT, an assistant professor with the Department of Physical Therapy, Nicole Wertheim College of Nursing and Health Sciences at Florida International University, who has been a physical therapist for 27 years. She has specialized in amputation rehabilitation for the last 16 years. “We certainly have research that has established cut-off scores for many common outcome measures that correspond to past falls; the majority of this research has been cross-sectional or retrospective in nature,” she says. “However, because there is a dearth of longitudinal/prospective fall research in people with lower-limb amputation, we lack the ability to assess if these outcome measures are predictive of future falls.” Much of Clemens’ research interests lie in examining health disparities in those with amputations and biomechanical analysis of people with lower-limb amputations. “Additionally, teaching our future physical therapists and prosthetists techniques to maximize functional outcomes in their patients with limb loss is a passion of mine as, often, physical therapy curriculums do not reserve much time to teach amputation rehabilitation,” says Clemens. A Research Scientist’s POV Miller has experience in patient-reported outcomes assessing health utility and qualitative research. “Measuring and assessing patient outcomes such as fall history and risk of falls, is one of the best ways to communicate to other key stakeholders in the decision-making process,” she says. Miller and the research team at Hanger Institute recently studied injurious falls associated with Prosthetic Limb Users Survey of Mobility (PLUS-M) scores. Miller says researchers found that individuals with lower-limb amputations who had mobility scores lower than 36.75 were more likely to have experienced an injurious fall (PLUS-M scores represent a higher level of mobility around 71.4). Another study, “Mobility Analysis of Amputees (MAAT II),” published by the Hanger Institute in April assessed lifetime mobility scores across several common etiologies and across ages. “These two studies when considered together can help clinicians better assess their patient’s personal situation and use the PLUS-M as a tool to track mobility over time,” Miller says. An Associate Professor’s POV Andrew Sawers, PhD, CPO, is an associate professor in the Department of Kinesiology at the University of Illinois at Chicago. The department’s research lab focuses on balance and falls in lower-limb prosthesis users, using biomechanical, epidemiological, and qualitative research methods to study balance and falls in that population. Existing evidence suggests that the prevalence of falls in lower-limb prosthesis users places them at a high risk for adverse health outcomes that include activity limitations and participation restrictions, injuries, and reduced quality of life, Sawers and a team of researchers concluded in their study, “Recalled Number of Falls in the Past Year—Combined With Perceived Mobility—Predicts the Incidence of Future Falls in Unilateral Lower Limb Prosthesis Users.” “Assessing who is at risk for falls remains a challenge,” he says. How Frequent Are Falls? The clinicians we interviewed cite research that reports at least 50 percent of adults living with lower-limb amputations experience at least one fall annually. “What is perplexing is that some research reports that people with lower-limb amputations that are functioning at a higher level tend to report more falls,” Clemens says. “This is different than falls in other patient populations.” Sawers says data on this research can vary. “The prevalence of falls reported in retrospective studies varies between 50 percent and 63 percent of lower-limb prosthesis users, while the incidence of falls reported in prospective studies varies between 44 percent and 56 percent,” he says. The reporting duration—one month, six months, one year, and how (or if) falls were defined—may also be confounding factors, he says. Not all lower-limb prosthesis users who fall experience a serious injury as a result, according to experts. Sawers echoes that this research data can vary study to study and can likely depend on the type of study (retrospective versus prospective), study duration (length of reporting period), and how or if an injurious fall is defined, he says. “These factors aside, the retrospective prevalence of injurious falls ranges from 18 percent to 19 percent of lower-limb users, while prospective incidence of injurious falls has been reported twice, [at] 27 percent and 33 percent of lower-limb prosthesis users.” Although current evidence suggests that the vast majority of people with lower-limb amputations who fall do not sustain an injury that is serious enough to require medical attention, Clemens takes the consequences of falling a step further. “Even noninjurious falls could result in decreased confidence and lead to someone limiting their activity level as a result,” she says. Never FOOSH While serious falls can lead to death, there are other consequences lower-limb prosthesis users can face as a result of a fall, from a health, emotional, and financial standpoint. “Certainly, even without injury, a fall can lead to embarrassment and decreased confidence,” says Clemens, who added that such psychological aspects of falling could affect how much the person decides to partake in other activities. “For instance, they may avoid going to a park for fear that uneven terrain will trip them up, and that they’d be ‘safe’ by just staying home,” she says. “This can be physically and emotionally detrimental to someone’s health and could ultimately result in increased sedentary lifestyles and isolation from family and friends.” Can those with lower-limb amputations fall in such a way to avoid injury? The short answer, some of our experts say, is yes. “As a physical therapist we try to instruct patients to never fall on an outstretched hand (FOOSH),” Clemens says. Taking lessons from populations who experience many falls—such as athletes and military personnel—teaching patients exercises that instruct them to tuck, round, and roll if they are falling may soften the landing and help mitigate injuries during the fall, Clemens says. One way to lessen falls is for people with amputations to stay physically strong, maintain a healthy lifestyle, and incorporate regular balance exercises, Clemens says. “This may not prevent a fall, but it would likely minimize risk and prevent any injury that would result from falling,” she says. Sawers says the question is more difficult to answer. “We are starting to understand what amputees need to do to minimize injury while falling (brace themselves, tuck and roll, grab on to something to slow their descent) but this is all unpublished and anecdotal,” he says. “I would say it still needs to be determined.” He also adds that what can be done to help mitigate falls in this population still being determined. “There is mild to moderate evidence that microprocessor knees (MPKs) might help reduce the frequency of falling in transfemoral users, but this is not definitive,” he says. Sawers also says there is an emerging body of literature looking at perturbation training, which seems to indicate that repeated exposure to trips or slips in a controlled and safe laboratory environment may reduce the frequency of falls in otherwise young, healthy transtibial prosthesis users. It is worth noting, Sawers says, that perturbation training is likely limited to reducing the specific type of fall that was trained (trip versus slip, forward, backward, lateral). “A major issue with any intervention is determining who needs it, who is at risk. We need to be able to predict the risk of fall-related events, diagnose why someone is at a greater risk for fall-related events, and then have the evidence to match that need to deficit with the appropriate intervention,” he says. Miller says she advises patients to speak with a physical therapist who specializes in post-amputation rehabilitation or ask their prosthetists to assist them. There are techniques to falling, Miller says, to minimize injury, as well as different suggestions on adapting an environment to prevent falls, including something as simple as reducing opportunities to trip. “Beyond that it may be appropriate for a patient to discuss their prosthesis design with their prosthetist,” she says. “A recent study by our team, ‘Stability and Falls Evaluation in AMPutees (SAFE-AMP 1),’ found that individuals with diabetes and/or vascular disease who used MPKs had over two times reduced odds of falling compared to non-MPK users.” Clemens says she also tells her patient population the same: “Remove throw rugs from your home or anything else that might be a tripping hazard.” Does Age Make a Difference? In general, age is not associated with fall frequency in established lower-limb prosthesis users, one year after amputation, Sawers says. “A few studies have suggested that age is related to the odds of an injurious fall, but we recently submitted a paper for peer review that suggests age does not increase the risk for injurious falls in lower-limb prosthesis users,” he says. Miller points out that about 30 percent of all individuals in the United States over 65 fall each year with estimated Medicare costs to treat resulting injuries reaching over $31 billion. There are several known factors, Miller says, that increase an individual’s odds of falling. “Experiencing a fall itself can increase risk due to increased fear of falling again or self-induced [decline in activity],” she says. “Individuals with chronic disease and disability, regardless of age, report having lower functional mobility, which can contribute to fall risk.” Additional risk in people with a lower-limb amputation may be attributed to unique conditions such as balance disturbance due to amputation, she says. Miller cites one of their recent studies, now under review, which found that age was not associated with increased odds of injurious falls, however, “this does not mean aging does not contribute to loss of muscle mass or balance or other comorbidities that occur as we age, such as loss of eyesight.” Miller says the results suggests that age alone won’t predict a fall, but rather it should be considered in addition to other personal factors such as a patient’s experience with a prosthesis, type of prosthesis, and current mobility. She gives the example that “SAFE-AMP 1” demonstrated the large effect that MPK technology has on reducing the odds (2.5 times less) of incurring an injurious fall among people with diabetes and/or dysvascular disease. “However, the causes of falls and risk factors for falling are multifaceted and further complicated when multiple comorbidities exist,” she says. Fascinating Subject Clinicians, it seems, find the risk of falling among lower-limb prosthesis users to be an interesting subject. Says Clemens, “The fact is we aren’t sure which factors increase an amputee’s risk of falling over someone else with a lower-limb amputation, and that a lot of research still needs to be performed in this arena.” Miller says she is passionate about equitable access to healthcare, including O&P services, given the connection between practice, policy, and research evidence. “O&P services are essential to millions of people’s health and functional globally, yet published evidence supporting what may seem logical to orthotists and prosthetists is lacking,” she says. Miller agrees with Clemens and says there is a lack of real-world evidence documenting the impact a prosthesis has on injurious falls, mobility, and other measures of functional health and well-being. Miller believes a lower-limb prosthesis empowers the user to be more functionally independent, prevents injurious falls, and can improve cardiovascular health. “I hope my research on falls and other outcomes that are important to patients will directly benefit patients in terms of individual care, reduce barriers to critical technology, inform policy and clinical practice, and ultimately help people achieve their goals,” she says. Falls are a complex health-related problem that Sawers says requires a multidisciplinary approach to both the science and the dissemination of the results. There is seemingly no doubt that those with lower-limb amputations are exceptional, our experts agree. “Amputees are a unique population unlike any other,” Clemens says. “And tailoring research to address falls in this population is necessary to expand what we know and what we don’t know.” Betta Ferrendelli can be contacted at betta@opedge.com .

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Fall Risk: A Dearth of Real-world Evidence

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