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

Abstract

Background: Foot problems are prevalent in older adults, which may increase the risk and concern for falls. Ankle-foot orthoses (AFO) have been shown to be effective in the stabilization of lower extremities, but their long-term effectiveness in improving balance and their potential to encourage older adults to become more physically active are still debated. Objective: This randomized controlled trial investigated the effectiveness of daily use of a custom-made AFO on balance, fear of falling, and physical activity in older adults. Study Design: Forty-four older adults with concern about or at risk for falling were randomly allocated to either the control group (CG; 77.3% female, age 75.6 ± 6.5 years, BMI 29.3 ± 6.4) or the intervention group (IG; 63.6% female, age 73.7 ± 6.3 years, BMI = 27.8 ± 4.8). The IG received walking shoes and bilateral custom-made AFO. The CG received only walking shoes. At the baseline and 6-month follow-ups, balance and physical activity were assessed using validated wearable instrumentation and fear of falling was assessed using the Fall Efficacy Scale-International (FES-I). Adherence and acceptability toward wearing the AFO were assessed using self-reported questionnaires at the 6-month follow-up. Results: No significant between-group difference was observed at baseline (p = 0.144–0.882). Compared to baseline and the CG, hip, ankle, and center-of-mass (COM) sways were significantly reduced at the 6-month follow-up in the IG while standing with the feet together during the eyes-open condition (p = 0.005–0.040). Within the IG, the FES-I was reduced significantly (p = 0.036) and there was an increasing trend in the number of walking bouts with a medium effect size (d = 0.52, p = 0.440) compared to baseline. However, there were no significant changes in FES-I and physical activity measures in the CG (p = 0.122–0.894). The reduction in COM sway in the IG was moderately correlated with adherence (r = –0.484, p = 0.047) and strongly correlated with baseline COM sway (r = –0.903, p < 0.001). Conclusion: Results suggest that bilateral custom-made AFO plus walking shoes is effective in improving balance compared to walking shoes alone, and it significantly reduces the fear of falling, with a nonsignificant but noticeable positive trend in physical activity, compared to baseline. The results also suggest that older adults with poor balance at baseline and higher daily adherence to using the AFO will gain more benefit from the AFO intervention.

Daily Use of Bilateral Custom‐Made Ankle‐Foot Orthoses for Fall Prevention in Older Adults: A Randomized Controlled Trial

“…The fall prevention effects of AFOs could be attributed to improvements in balance and reduction in fear of falling thanks to ankle stability and enhanced somatosensory feedback provided by AFOs. This hypothesis is supported by our previous publication from this RCT, in which we have demonstrated that the 6‐month daily use of bilateral custom‐made AFOs is effective to reduce the fear of falling compared to baseline. Also, our previous study revealed a significant reduction in ankle sway (an indicator of ankle stability) and center of mass sway (an indicator of postural control) compared to baseline and compared to the CG in response to daily use of AFOs .…”

“…This hypothesis is supported by our previous publication from this RCT, in which we have demonstrated that the 6‐month daily use of bilateral custom‐made AFOs is effective to reduce the fear of falling compared to baseline. Also, our previous study revealed a significant reduction in ankle sway (an indicator of ankle stability) and center of mass sway (an indicator of postural control) compared to baseline and compared to the CG in response to daily use of AFOs . Prior studies have suggested that reduction in fear of falling and postural sway are linked to lower fall risk in older adults .…”

“…Prior studies have suggested that reduction in fear of falling and postural sway are linked to lower fall risk in older adults . Additionally, the high adherence and the high acceptability of AFOs reported in our previous study could be an important factor that contributed to converting the improvement in the balance and fear of falling to an actual reduction in falls.…”

“…Details of the study design have been described in our previous study . In short, we recruited 44 older adults from outpatient clinics or education centers for seniors/older adults at the Houston metropolitan area, TX.…”

“…To overcome this limitation, we conducted a longitudinal randomized controlled trial (RCT) to investigate the effectiveness of daily use of bilateral custom‐made AFOs on fall prevention. Our previous article demonstrated that 6‐month daily use of bilateral custom‐made AFOs could improve balance in community‐dwelling older adults with concern about or at risk for falling, but that article only reported the parameters related to fall risk. It was still unclear whether the daily use of AFOs could directly reduce prospective falls.…”