Emphasizing The Need For Accurate Reporting Of Research On Falls And AFOs

For several years, I have been a critic of a practice within the podiatric profession of prescribing bilateral ankle-foot orthoses (AFOs) to senior citizens with a promise that these devices would reduce the risk of falling.^1-3

Among several concerns is the fact that this treatment intervention has never had testing in any robust clinical trial to ensure the safety of the practice. In addition, the brace was marketed before any studies had occurred to verify that the promised benefit of preventing falls was actually legitimate.

Five years after introducing a brace promising “falls prevention,” the manufacturing company has sponsored research that purportedly validates the benefits of the device.⁴ According to a press release that appeared on Podiatry Management (PM) News, “Older adults may be able to avoid falls due to balance instability by wearing custom-made ankle foot orthoses.”⁵ Furthermore, the press release states that, “The study showed improvement in all balance-related assessments.” It is disappointing to examine the published manuscript and learn that these statements made in a press release to the podiatric profession are entirely false.  

The research team at the Center for Lower Extremity Ambulatory Research (CLEAR) at the Dr. William M. Scholl College of Podiatric Medicine conducted the study of interest.4 Contrary to the press release in PM News, this was not a study of fall prevention in older adults. Instead, it was a simple laboratory test of balance measures and mobility measures in elderly people with and without a custom AFO. The study included 30 ambulatory adults using three tests for balance and mobility: Romberg’s balance, functional reach and Timed Up and Go.

Only the Romberg’s test showed significant improvement of balance when patients wore the test AFO brace.⁴ In quiet stance, each patient performed the test standing on both feet with arms crossed, eyes open and then eyes closed. The test brace reduced sway in comparison to the barefoot and shoes alone condition. Many other studies of various styles of non-custom ankle braces have shown similar results with simple Romberg testing.^6-9 

The functional reach test did not show any improvement in distance with the AFO brace.⁴ A test for “coordination” during the functional reach did measure a difference with the AFO brace but the interpretation of this finding is debatable. If improved coordination actually occurred with the AFO brace, it certainly did not lead to improved functional reach distance, which would indicate improved balance.

The Timed Up and Go test is a gold standard for assessment of functional mobility and fall risk in many patient populations.^10,11 When participants wore the test AFO brace, there was no improvement when performing the Timed Up and Go test. If this brace had any potential for fall prevention as this study intended to prove, the test results should have shown benefit.

So the AFO balance brace failed in two out of the three parameters tested but the researchers proceeded in the discussion section to suggest that the AFO brace could be useful for fall prevention in the elderly.⁴ However, the study never measured the incidence of falling with and without the AFO brace. The gold standard test for fall prevention, which the researchers chose to use in their test protocol, showed no improvements in fall risk with the AFO device. The Timed Up and Go was the only test that has direct correlation with fall prevention and the brace failed to show any improvement in this part of the study. Yet the authors of the study proposed that this brace could be useful in fall prevention.

Furthermore, at least four previously published studies that showed improvements in balance tasks with ankle bracing never made the unjustifiable conclusion that ankle braces would prevent catastrophic falls.^6-9 No research team has measured improvements with taping or bracing during a simple Romberg’s Test and made the unjustified leap to speculation that the tested brace could prevent catastrophic falls in the elderly. 

Since the AFO brace company was the commercial sponsor of the published research, one has to wonder what influence this had on the interpretation and reporting of the results by the team at CLEAR.  The manuscript indicates that “neither the manufacturer nor the parent company had any role in the collection of data, analysis of data, and the preparation of this manuscript.” Given the misinformation provided in the press release and the unwarranted conclusions about falls prevention in the discussion section of the published paper, one has to wonder if the research institution was somehow bent on satisfying the sponsor for other reasons.

While I applaud any original research into the effects of ankle bracing, this study and the press release that misrepresented the results to the profession certainly raise questions about the influence that corporate funding has on the purity of reporting of published research findings.

References

1. Christensen JC, Richie D Jr. Point-counterpoint: do AFOs have a role in fall prevention? Podiatry Today. 2013; 26(10):42-49.

2. Richie D Jr. The truth about AFOs and fall prevention. Podiatry Today. Available at https://www.podiatrytoday.com/blogged/truth-about-afos-and-fall-prevention . Published Feb. 24, 2012. Accessed Feb. 4, 2015.

3. Richie D Jr. Still looking for documentation that AFOs effectively prevent falls. Podiatry Today. Available at https://www.podiatrytoday.com/blogged/still-looking-documentation-afos-effectively-prevent-falls . Published June 25, 2012. Accessed Feb. 4, 2015.

4. Yalla SV, Crews RT, Fleischer AE, Grewal G, Ortiz J, Najafi B. An immediate effect of custom-made ankle foot orthoses on postural stability in older adults. Clinical Biomechanics. 2014; 29(10):1081–108.

5. PM News. Available at https://podiatrym.com/search3.cfm?id=79891 . Published Jan. 28, 2015. Accessed Feb. 4, 2015.

6. Baier M, Hopf T. Ankle orthoses effect on single-limb standing balance in athletes with functional ankle instability. Arch Phys Med Rehabil. 1998; 79(8):939-944.

7. Kinzey SJ, Ingersoll CD, Knight KL. The effects of selected ankle appliances on postural control. J Athl Train. 1997; 32(4):300-303.

8. Barkoukis V, Sykaras E, Costa F, Tsorbatzoudis H. Effectiveness of taping and bracing in balance. Percept Mot Skills. 2002; 94(2):566-574.

9. Wikstrom EA, Arrigenna MA, Tillman MD, Paul AB. Dynamic postural stability in subjects with braced, functionally unstable ankles. J Athl Train. 2006; 41(3):245-250.

10. Podsiadlo D, Richardson S. The timed “up & go”: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991; 39(2):142–148.

11. Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the timed up & go test. Phys Ther. 2000; 80(9):896–903.