New Studies Refute Claims Of Fall Prevention With AFO Bracing

In 2011, a new custom ankle foot orthotic (AFO) brace, herein referred to as the Moore Balance Brace, was introduced to the podiatric community. From the outset, the Moore Balance Brace was marketed and promoted to prevent falls in the elderly. After this product launch, I immediately called attention to the fact that no AFO had ever been proven to prevent falls in the elderly population and asked the manufacturer and inventor of this brace to provide studies verifying their claims.¹

As I have disclosed in all of my postings on this subject, I own an AFO company. I have published research on balance and postural control.^2-4 Based upon my knowledge and experience, I am concerned that a company would make a claim that a brace could prevent a catastrophic event such as a traumatic fall without sound scientific evidence substantiating such a monumental medical achievement.

Since that original DPM Blog, I have written several other pieces criticizing the practice of promoting and promising that a custom AFO brace could prevent falls in the elderly population.^5-7 My concern ultimately lies with frail elderly patients who are prescribed these braces under the guise that wearing them would protect the user from suffering a catastrophic fall.

In reading website postings over the years, there have been statements made by the inventor and the manufacturer of the Moore Balance Brace that research was being conducted to prove that this brace could prevent falls in the elderly. For a period of time, I saw multiple advertisements in podiatric trade publications stating that the Moore Balance Brace was “clinically proven” as a fall prevention intervention.⁸

Eight years after the market launch of the Moore Balance Brace, two long-awaited studies have been published. These randomized, controlled trials (RCTs) tested a “custom-made AFO” (referred to only once in the study as a Moore Balance Brace) to determine if there were any fall prevention benefits.^9,10 Both studies were sponsored in part by Orthotic Holdings Inc. (OHI), the company which manufactures and sells the Moore Balance Brace. In summary, both studies refute the notion that wearing bilateral balance braces will reduce the fear of falling or reduce the incidence of falls in the elderly population.  

These two studies, which were conducted at the Baylor College of Medicine, involved 22 people (mean age of 73 years) in the intervention group (IG), who received bilateral “balance brace” AFOs and wore them for all standing and walking activities. A control group of 22 people (mean age of 75 years) did not wear AFO braces. Both groups were fitted for and wore New Balance footwear during the study.

In the first study, the researchers focused on outcome measures of static balance (sway) as well as activity levels and fear of falling.⁹ After six months, the treatment group had improved static balance with reduced sway while standing with their eyes open. There were no measures of dynamic balance that are more predictable of falls risk. The Timed Up and Go (TUG) test has shown good reliability to predict fall risk with a sensitivity and specificity of 87 percent.^6-8 Curiously, researchers performed the TUG test on all subjects at the beginning of this study but did not perform this test at the conclusion. We are reminded that a previous study showed that the balance brace did not improve TUG scores in laboratory testing.¹¹

The first study attempted to measure fear of falling using the Falls Efficacy Scale International (FES-I).¹² At a six-month follow-up, in comparison to the control group, the intervention group wearing bilateral balance brace AFOs showed no significant change in fear of falling. As the researchers reported: “no significant difference was found in the change of FES-I score at the 6-month follow-up between groups.”

Normally, in any quality RCT, this would be “end of story” regarding any measured effect of reduced fear of falling in the intervention group wearing bilateral AFO braces. However, when the between group comparisons failed to show a difference, the investigators breached accepted protocol for RCTs and performed a within group analysis of fear of falling, looking only at the intervention group (IG) and not comparing to the control group. The authors state: “the reduction of the FES-I score was significant (p = 0.036) within the IG (online suppl. Fig. S2), and this reduction had a medium effect size (d =0.58).”⁹

Herein is a basic violation of RCT methodology and reporting of results. Quality randomized controlled trials should compare treatment results between the intervention group and the control group. Just because your data does not support the anticipated outcome, you should not modify your methodology afterward and evaluate within group changes that have no merit in outcome studies. Within group comparisons, as performed in both of these recent balance brace studies, ignore the control group and therefore ignore placebo effects and the statistical effects of regression toward the mean.

Regarding proper RCT protocol and reporting, Bland and Altman state that researchers should make final comparisons between groups rather than within groups: “To anybody who understands what ‘not significant’ means, it should be obvious that within-group testing is illogical. It should also appear so to anyone who has attended an introductory research methods course, which would have mentioned the importance and use of a control group. … Randomised groups should be compared directly by two-sample methods and separate tests against baseline are highly misleading.”¹³

In summary, the first of two balance brace studies performed at Baylor College of Medicine showed improvement in sway with wearing bilateral balance braces for six months but did not show improvement of fear of falling in comparison to the control group after six months of use.

The second RCT studying balance braces utilized the same people from the first RCT, who had already been randomized into control (no brace) and intervention (balance brace) groups.¹⁰ Both groups were fitted for and wore New Balance footwear during the study. In this second study, the primary goal was to determine if use of bilateral balance braces would prevent the incidence of falls after 12 months of use by an elderly population.  

Participants reported how many falls they had experienced in the previous year and then at three, six and 12 months during the study.¹⁰ This is a major limitation as it requires an elderly person to remember an event as far back as one year. The “gold standard” approach is immediate documentation of falls using a daily calendar and follow-up phone calls. This study also had a substantial dropout rate (23 percent in the control group and 31 percent in the intervention group).

Notwithstanding these limitations, the results of the second RCT were clear and unequivocal. At the 12-month follow up, when comparing the incidence of falls, there was no significant difference between the balance brace group and the control group who did not wear balance braces. As the researchers concluded: “This study failed to demonstrate a significant benefit of bilateral custom-made AFOs to reduce falls compared to fitted walking shoes.”¹⁰

End of story? Not so fast. Unable to validate the original hypothesis that wearing bilateral balance braces would reduce falls, the researchers again attempted to show some positive findings by performing within group analysis in comparison to baseline. With this flawed analysis, there was a reduction in the number of falls reported by the intervention group during the 12-month study period in comparison to the previous year.

There are three major problems with reporting these results.

1.    Evaluating findings within the study group and not comparing to the control group violates accepted statistical analysis for RCTs as I noted above. As Bland and Altman state, reporting within group changes and not comparing to a control group while only comparing these results with baseline provides “highly misleading results.”¹³
2.    The placebo effect of patients wearing braces designed to prevent falls and being tested over one year to prevent falls could be profound in the intervention group in comparison to the group who did not get braces (i.e. the control group).
3.    The baseline figures, which require an elderly patient to remember how many falls he or she had sustained the previous year, would be highly suspect for accuracy.

The question remains why did the investigators not follow accepted protocol for RCTs in reporting their results? When the findings relative to fear of falling and actual incidence of falling did not validate the efficacy of the balance brace, why did these researchers ignore the control group and search for positive results only within the test group?

At the end of each published study from the Baylor College of Medicine, the authors disclose the corporate support but maintain no influence from OHI:^9,10

Financial Disclosure: The study is supported, in part, by a grant from Orthotic Holdings, Inc., and, in part, by a grant from the National Institute of Aging (R42-AG032748). However, the funding sources did not play any role in the design of the study, analyses of the data, interpretation of the results, and manuscript preparation.

However, the authors also disclose the participation of an OHI officer in the design of the study: The authors would like to acknowledge Josh White, DPM, CPed, with his expert support while designing this clinical study.^9,10  

Whether or not there was corporate influence, the two studies conducted at Baylor College of Medicine and sponsored in part by OHI should have followed standard RCT protocol and reported the final results based upon between-group comparisons. The final results should have been reported exactly as Hylton Menz, PhD, DSc, reported in his recent blog reviewing the two studies from Baylor.¹⁴ Dr. Menz, arguably one of the world’s leading authorities on fall prevention, came to the following conclusion after reading the two recent studies from Baylor:

“These welcome additions to the falls literature strengthen the argument that interventions such as AFOs are not sufficient to prevent falls when used in isolation. Instead, clinicians need to consider multifaceted interventions (incorporating footwear, orthoses and exercise), which have demonstrated evidence of effectiveness.”  
 
References

1.    Richie D. The truth about AFOs and fall prevention. Podiatry Today DPM Blog. Available at: https://www.podiatrytoday.com/blogged/truth-about-afos-and-fall-prevention . Published Feb. 24, 2012. Accessed May 21, 2019.
2.    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.
3.    Richie DH Jr. Effects of foot orthoses on patients with chronic ankle instability. J Am Podiatr Med Assoc. 2007; 97(1):19-30.
4.     Rome K, Richie D Jr, Hatton AL. Can orthoses and insoles have an impact on postural stability? Podiatry Today. 2010; 23(10):43-51.
5.    Christensen JC, Richie D. Point-counterpoint: do AFOs have a role in fall prevention? Pod Today. 2013;26(10):42-49.
6.    Richie D. AFO bracing and the elderly: what the literature reveals. Pod Today. 2018;31(5):36-42.
7.    Richie D. Emphasizing the need for accurate reporting of research on falls and AFOs. Podiatry Today DPM Blog. Available at: https://www.podiatrytoday.com/blogged/emphasizing-need-accurate-reporting-research-falls-and-afos . Published Feb. 6, 2015. Accessed May 21, 2019.
8.    Arizona AFO advertisement. Lower Extremity Review. Available at https://lermagazine.com/wp-content/uploads/2015/11/LER10-15.pdf . Page 51.
9.    Wang C, Goel R, Rahemi H, Zhang Q, Lepow B, Najafi B. Effectiveness of daily use of bilateral custom-made ankle-foot orthoses on balance, fear of falling, and physical activity in older adults: a randomized controlled trial. Gerontology. 2019; 65(3):299–307.
10.    Wang C, Goel R, Rahemi H, Zhang Q, Lepow B, Najafi B. Daily use of bilateral custom-made ankle-foot orthoses for fall prevention in older adults: A randomized controlled trial. J Am Geriatr Soc. 2019; epub Apr 24.
11.    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. Clin Biomech. 2014; 29(10):1081–108.
12.    Delbaere K, Close JC, Mikolaizak AS, Sachdev PS, Brodaty H, Lord SR. The Falls Efficacy Scale International (FES-I). A comprehensive longitudinal validation study. Age Ageing. 2010; 39(2):210–6.
13.    Bland JM, Altman DG. Comparisons against baseline within randomized groups are often used and can be highly misleading. Trials. 2011;12:264.
14.    Menz HB. No significant reduction in falls with Moore Balance Braces. 2019. Available at: https://www.hyltonbmenz.com/2019/05/no-significant-reduction-in-falls-with.html . Accessed May 21, 2019.