The Truth About AFOs And Fall Prevention

Doug Richie Jr. DPM FACFAS

Recently, a prominent podiatric company began marketing an ankle-foot orthosis (AFO) as the centerpiece of a fall prevention program targeted at elderly patients. To learn that a commonly used orthopedic device could now be used to prevent a catastrophic medical event would prompt any reasonable practitioner to look for the scientific evidence that could validate such a profound accomplishment.

After conducting a search of the medical literature, I am both disappointed and astonished to learn that there are no valid scientific studies to prove that any AFO can prevent falls in any patient population. Even more surprising is the credible scientific evidence that certain AFO braces may actually compromise balance and postural control. This could put certain patient populations at a greater risk for catastrophic falls.

I became interested in the biomechanics of ankle-foot orthoses when I designed and patented several ankle braces in the mid-1990s. I focused much of my research on balance, proprioception and neuromuscular control of the lower extremity.1 Later, I published a review of fascinating research that had been conducted on balance, postural control and prevention of ankle sprains using foot orthoses as the only treatment intervention.2,3

During this time, I realized that multiple disciplines studying the cause and prevention of falls in the elderly community had been conducting the research. Much of the knowledge about neuromuscular control in athletes appeared to have some relevance to fall prevention in the elderly. I was pleasantly surprised to learn that our podiatric colleagues in Australia contributed a substantial amount of knowledge and insight into fall prevention. They now lead the world in teaching the role of podiatry in fall prevention.4-7

Last year, at the American Podiatric Medical Association (APMA) National Meeting, I had the honor of presenting an overview of the research that our Australian podiatric colleagues had conducted. I presented an entire lecture devoted to fall prevention. In this lecture, I pointed out the key components of the fall prevention program, which were recently published in the British Medical Journal.8 The essential elements of this program include a subsidy and education for selection of footwear, a prefabricated foam foot orthosis, a home-based foot exercise program, regular podiatric care and a take-home educational brochure on fall prevention. Podiatric physicians implemented this multifaceted program, which reduced falls in elderly patients by an astounding rate of 26 percent.

At the APMA National, I also reviewed the role of AFOs and risk of falls, summarizing the current scientific research. The bulk of today’s research documents the negative effects of AFOs on balance and postural control. The problem is so significant that the American Academy of Orthotists and Prosthetists held a special conference to study the effects of AFOs on balance in June 2010.

In the proceedings of this conference, Ramstrand and Ramstrand performed a systematic review looking at all studies of AFOs and their effects on balance.9 Most of the studies have focused on patient populations who commonly use AFOs: those with hemiplegic, traumatic brain injury, cerebral palsy and multiple sclerosis. This review found mostly negative effects on balance with any type of solid or ankle restrictive AFO device. Researchers discovered minimal effects on balance with hinged AFO devices, either positive or negative.

There is some evidence that posterior leaf-spring AFOs may improve balance and postural control in patients with hemiplegia, but this has not been proven in other patient populations, including the elderly.9 However, the authors caution that “of particular interest were rigid orthoses that resulted in either no change or improvement of performance on static balance tests but deterioration in performance under dynamic test conditions. This result is not surprising given that dynamic balance requires a degree of ankle joint motion that is intentionally inhibited in rigid orthoses.”9

There have been no studies published showing positive effects of AFOs to improve balance and postural control in elderly adults during dynamic gait. Furthermore, there have been no studies published to show that any type of AFO will prevent falls in any patient population, let alone elderly subjects. An excellent overview, recently published in Lower Extremity Review, highlighted the role of AFOs in balance and falls.10

Could Unsubstantiated Claims About Prevention Adversely Affect Medicare Coverage Of AFOs?

My other concern is the perception that practitioners may have that an AFO prescribed to prevent falls in a patient at risk would be covered by most insurance companies including Medicare and Medicaid. I would ask how such a device could be eligible when the primary indication is the prevention of an event rather than the treatment of an actual medical condition.

While we often prescribe foot orthoses or ankle-foot orthoses to treat a medical condition, we almost never tell our patients that wearing such a device will prevent an event. A medical event such as a heart attack, stroke or catastrophic fall is a profound occurrence that can lead to death. The cause of such events is always multifactorial.

Over the years, many have developed clinical interventions and pharmaceutical products with a goal of preventing an event such as a heart attack or stroke. Researchers have invested billions of dollars in Level 1 studies to prove that the intervention has a significant preventive effect. No credible company or individual would market a product to the medical profession with a claim that the product could prevent a catastrophic event without doing their due diligence in conducting appropriate clinical trials. Certainly, the FDA would prohibit any marketing of a device intended to prevent an event that did not have multiple Level 1 scientific evidence to back up the claims.

From a public health perspective, falls in the elderly are just as important as heart attacks and strokes. One in three adults over the age of 65 suffers an accidental fall each year and half of these falls result in some type of injury.11 Falls are the leading cause of injury in older adults and are the leading cause of death in people over the age of 85.12,13 Therefore, a physician or company who announces a new technology that will prevent a catastrophic event such as a traumatic fall would certainly garner attention and scrutiny of such a monumental achievement.

When this technology has no published research to back up its claim, the initial ramifications for the podiatric profession are not only embarrassing, they could affect our Durable Medical Equipment provider status with Medicare. Prevention of falls is not an indication for prescribing an AFO, according to the current published Medicare guidelines. If podiatric physicians begin prescribing bilateral AFOs to elderly patients with this treatment goal in mind, Medicare is certainly going to take notice. Scrutiny of everything we do with these valuable devices is likely to follow.

In Conclusion

I will continue to support any program or initiative that will potentially reduce the risk of falls in any patient population. As our Australian colleagues have already demonstrated, podiatric physicians can play a critical role in fall prevention in the elderly. None of the evidence validates the use of any type of AFO in such a program. If convincing Level 1 evidence becomes available that certain designs of ankle-foot orthoses can prevent falls, I will add that clinical indication in the promotion of any device, including my own current line of products that meet the criteria.

Until that happens, I will continue to educate and inform my colleagues of the credible scientific evidence relative to fall prevention so they can make the right decisions for their patients.

References
1. Richie DH. Functional instability of the ankle and the role of neuromuscular control. A Comprehensive Review. J Foot Ankle Surg. 2001; 40(4):240-251.
2. Richie DH Jr. Effects of foot orthoses on patients with chronic ankle instability. J Am Podiatr Med Assoc. 2007; 97(1):19-30.
3. Rome K, Richie D Jr, Hatton AL. Can orthoses and insoles have an impact on postural stability? Podiatry Today. 2010; 23(10):43-51.
4. Sherrington C, Menz HB. An evaluation of footwear worn at the time of fall-related hip fracture. Age Ageing. 2003; 32(3):310-4.
5. Menz HB, Morris ME, Lord SR. Footwear characteristics and risk of indoor and outdoor falls in older people. Gerontology 2006; 52(3):174-80.
6. Menz HB, Morris ME, Lord SR. Foot and ankle risk factors for falls in older people: a prospective study. J Gerontol A Biol Sci Med Sci. 2006; 61(8):866-70.
7. Mickle KJ, Munro BJ, Lord SR, Menz HB, Steele JR. ISB Clinical Biomechanics Award 2009: toe weakness and deformity increase the risk of falls in older people. Clin Biomech. 2009; 24:787-91.
8. Spink MJ, Henz HB, Fotoohabadi MR, et al. Effectiveness of a multifaceted podiatry intervention to prevent falls in community dwelling older people with disabling foot pain: randomized controlled trial. BMJ 2011;342:d3411 doi:10.1136/bmj.d3411
9. Ramstrand N, Ramstrand S. AAOP State-of-the-science evidence report: the effect of ankle-foot orthoses on balance — a systematic review. SSC Proceedings 10: P4-P23, Oct 2010.
10. Groner C. Upstanding interventions: falls prevention in O&P. Lower Extremity Rev. 2011. Available at http://www.lowerextremityreview.com/cover_story/upstanding-interventions... .
11. Larsen ER, Mosekilde L, Foldspang A. Correlates of falling during 24 h among elderly Danish community residents. Prev Med. 2004; 39(2):389-98.
12. Centers for Disease Control and Prevention. Falls among older adults: An overview. Available at: http://www.cdc.gov/HomeandRecreationalSafety/Falls/adultfalls.html . Accessed February 25, 2011.
13. Centers for Disease Control and Prevention. Web–based Injury Statistics Query and Reporting System (WISQARS). Available at: http://www.cdc.gov/injury/wisqars . Accessed February 25, 2011.

Comments

I was very disappointed with Dr. Richie’s posting entitled, “The Truth about AFOs and Fall Prevention." To even suggest that the erroneous information posted by Dr. Richie was true and non-biased is laughable.

The problem with this post is that Dr. Richie holds a prominent position in our profession and when he presents information as “true” when he knows that it is not, it not only causes confusion but moreover, it calls into question motivation and honesty. Furthermore, to do so in defense of the profession he professes to love is disingenuous.

Dr. Richie is wrong on almost all fronts. While I will not use this forum as a platform to debate this issue with Dr. Richie, I will make available to anyone who is interested in learning what the non-biased medical literature actually says regarding AFOs and balance. The medical literature is replete with valid studies from around the world that conclude that a properly designed AFO can improve postural control, balance, ankle stability all while reducing ankle fatigue, postural sway and (contrary to Dr. Richie’s claim) reducing the risk of falling. The information pertaining to this subject is voluminous and I would be more than happy to share this information with any interested reader of this blog. Simply email me and I will send you a comprehensive summary of the medical literature on this topic: moorebalanceafo@yahoo.com

Dr. Richie’s motivation to present information that he knows to be untrue as true should be questioned. For example, in Dr. Richie’s post, he went on and on about studies that demonstrate a contraindication for “solid” AFO’s for certain classes of patients, knowing full well that the Moore Balance Brace is not a solid AFO and in fact allows for normal sagittal plane motion at the ankle. Why would he do that?

Dr. Richie indicated that there are no studies that were done on adult patients or done in functional gait when, in fact, he is keenly aware that there are many. Why would he do this?

Dr. Richie further claims that AFOs shouldn’t be dispensed for “fall prevention” purposes when he knows full well that a full biomechanical fall assessment tool has been created for this purpose to identify the underlying neurologic and mechanical risk factors. Why he try to create confusion in this regard?

The opportunity for podiatry to play an important role in fall prevention and balance is significant. The leaders in our profession should be clamoring to create better understanding, allocate research resources and be lobbying harder for even broader reimbursement for the important work that we do. To post an attack blog from a competitive AFO company full of half-truths and innuendo is destructive and counter to the goals of our evolving profession.

Jonathan Moore, DPM, MS

I stand by each and every statement made in my blog regarding the lack of published research on the role of AFOs and fall prevention in the elderly.

I am well aware of the document which Dr. Moore uses to provide scientific evidence to allegedly validate his brace. I have read it thoroughly and am very familiar with each and every article cited. The document is a gross distortion of the findings of each and every published article in an attempt to make the data relevant to elderly patients and fall prevention.

Quite simply, you cannot take studies on patients with hemiplegia and assume that the effects of bracing would be the same with elderly patients without hemiplegia. You cannot look at studies of healthy athletes with an ankle sprain and assume that the findings would be relevant to seniors. Most importantly, there are very few prospective, randomized studies which have proven the effectiveness of any intervention to prevent falls in any patient population.

Unfortunately for Dr. Moore, there are no studies of AFOs in preventing falls in the elderly and no studies showing the safety or efficacy of his device. Instead of attempting to attract more visitors to his website, I encourage Dr. Moore to respond to my challenge to provide evidence of such research on this blog forum.

Dr. Moore,

Since you have not responded yet to my previous request, let me again ask you to validate your assertion that there is "voluminous" published research to substantiate your claim that a plastic shell AFO, worn bilaterally by an elderly patient who is already identified at risk, will be at reduced risk for sustaining a catastrophic fall.

Surely, you should be able to provide our readers with at least one peer-reviewed prospective, randomized controlled study, which shows that any type of ankle-foot orthosis will prevent falls in an elderly population. Even better, it would be reassuring to see any peer-reviewed, prospective randomized controlled study, which demonstrates that your own specific plastic shell ankle-foot orthosis, worn bilaterally by an elderly patient screened and identified to be at risk, will not actually incur more falls than a control group.

I would assume that you would have conducted this vital research before making the claims about your brace and fall prevention which are found on your website and current advertising. The stage is set for you to show the readers what Level 1 evidence you have to back up your claims. We look forward to your reply.

As I said in my post, I will not use this blog to debate. I realize this is exactly what you would love to have happen for several reasons. However, I think those that actually care about this topic would rather read the studies themselves without your commentary. I don't think anyone fails to recognize that you believe you are right while I think you are wrong.

One point of order: Your logic of companies not using existing studies to support their products is flawed. The entire orthotic and prosthetic profession, as well as the central fabrication industry (including the brace that bears your name), incorporates the techniques, and mechanisms of action that are cited in previously published studies.

I repeat my offer of providing any interested party copies of the clinical studies that support AFO bracing as a key tool toward improving balance and preventing falls.
Please e-mail me at: moorebalanceafo@yahoo.com. (This is an email address, nothing else.)

Clearly, fall prevention entails more than just prescribing an AFO. It starts with a thorough fall risk assessment, PT/OT, education and proper foot wear. This is an exciting time for our profession to be involved in providing the tools to prevent seniors from falling.

Sincerely,
Jon

It is not surprising that Dr. Moore cannot cite even one study to support his claims about AFOs and fall prevention in the elderly. This substantiates the fact that there are no such studies.

In terms of his assertion that there are "clinical studies that support AFO bracing as a key tool toward improving balance and preventing falls," closer scrutiny of Dr. Moore's supporting documents reveal a serious flaw in scientific reasoning. Dr. Moore, in reviewing published papers in the field of balance and orthotic devices, assumes that if A =B, and B =C, and C =D, then A =D. Or, if patients with serious neurologic deficits show improvements in postural control with a certain AFO device, then they must also improve balance during dynamic gait, and therefore since balance deficits may increase the risk of falling, then improving balance with an AFO must be able to reduce the risk of falls, and this notion must carry over to the elderly population who do not have cerebral palsy or hemiplegia. No credible scientist or clinician would make such an illogical conclusion from the current available research.

Yes, the modern orthotics industry has produced a myriad of devices that are designed to treat a medical condition. Never in the history of this industry has a company introduced a device which is intended to prevent a catastrophic event. This is validated by the claim made by Dr. Moore on his website that his brace is the "first" brace marketed with a specific indication for falls prevention. This is a startling proclamation given the fact that there are no published studies showing the safety or efficacy of the device.

I am in agreement with Dr. Moore that this an exciting time for our profession to be involved in fall prevention for all of our patients at risk. In terms of providing tools to prevent catastrophic falls, there is no place for the use of bilateral plastic shell AFO devices. There is great validity of certain preventive interventions that have been tested and proven in robust clinical trials. These treatments are best taught to our profession by true experts who have conducted valid research and who do not have a financial interest in an intervention which has no proven merit.

For all those concerned, when it comes to prevention, longitudinal studies, quality of life issues and performance enhancement research, the Level I evidence that Dr. Richie calls for rarely exists.

Even when one surfaces, it is usually preliminary, short-term, self-funded and contains bias regarding the research or the conclusions more often than not.

Dr. Moore seems to have a logical progression to his biomechanical brace that is a beginning to finding a biomechanical device to help reduce falls and his intentions seem to be primarily trying to help mankind fall less.

There is not evidence as yet that it doesn't work or that the MBB is dangerous or that it will harvest negative side effects.

Time will prove the validity, danger or misuse of this and other biomechanical modalities as it is now being shown for STJ Neutral Orthotic devices that also have no Level I evidence.
That said, Root-ian devices have helped so many without the "proof," why not keep an open mind for now on this and other potential biomechanical inventions until they gain acceptance or become vestigial?

Disclaimer: I am the inventor and U.S. Patent holder of Functional Foot Typing and Wellness Biomechanics, and therefore have huge bias and profit motives in making this posting.

Dennis

Aloha,

Falls are important and costly and deadly.

Why are there not more NIH funded studies on this? Is the leading cause of death over 85 not important enough to fund studies for?

The last time I checked my algebra, A does equal D if A=B=C=D.

My Dad is a stroke survivor and needs all the balance assistance he can get.

"From a public health perspective, falls in the elderly are just as important as heart attacks and strokes. One in three adults over the age of 65 suffers an accidental fall each year and half of these falls result in some type of injury.11 Falls are the leading cause of injury in older adults and are the leading cause of death in people over the age of 85.12,13" Dr. R.

We do not have level one evidence yet but we believe that adding the patented composite spring lever device to either the Richie or Moore brace will enhance stabilty and energy efficiency during dynamic gait. Perhaps the NIH would like to fund us to find out if this is true.

Mahalo,
Steve

Dr. Steven King
Co-Inventor USPTO 8,353,968
Co-PI US DoD and Army Reseach SBIR A11-109
Managing Member Kingetics LLC

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