Supplementary Material for: 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

<b><i>Background:</i></b> 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. <b><i>Objective:</i></b> 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. <b><i>Study Design:</i></b> 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. <b><i>Results:</i></b> No significant between-group difference was observed at baseline (<i>p</i> = 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 (<i>p</i> = 0.005–0.040). Within the IG, the FES-I was reduced significantly (<i>p</i> = 0.036) and there was an increasing trend in the number of walking bouts with a medium effect size (<i>d</i> = 0.52, <i>p</i> = 0.440) compared to baseline. However, there were no significant changes in FES-I and physical activity measures in the CG (<i>p</i> = 0.122–0.894). The reduction in COM sway in the IG was moderately correlated with adherence (<i>r</i> = –0.484, <i>p</i> = 0.047) and strongly correlated with baseline COM sway (<i>r</i> = –0.903,<i> p &lt;</i> 0.001). <b><i>Conclusion:</i></b> 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.

**研究背景：** 足部问题在老年人群中高发，可增加跌倒风险并引发跌倒担忧。踝足矫形器（Ankle-foot orthoses, AFO）已被证实可有效稳定下肢，但其长期改善平衡能力的效果，以及能否推动老年人增加身体活动量，仍存在争议。
**研究目的：** 本随机对照试验（randomized controlled trial）旨在探究每日佩戴定制式踝足矫形器对老年人平衡能力、跌倒恐惧程度及身体活动水平的改善效果。
**研究设计：** 纳入44名存在跌倒担忧或跌倒风险的老年人，随机分为对照组（CG：女性占比77.3%，年龄75.6±6.5岁，体重指数（Body Mass Index, BMI）29.3±6.4）与干预组（IG：女性占比63.6%，年龄73.7±6.3岁，BMI为27.8±4.8）。干预组配备步行鞋与双侧定制式踝足矫形器，对照组仅配备步行鞋。在基线与6个月随访阶段，采用经过验证的可穿戴检测设备评估平衡能力与身体活动水平，使用跌倒效能感国际量表（Fall Efficacy Scale-International, FES-I）评估跌倒恐惧程度；并于6个月随访时通过自填问卷评估受试者佩戴踝足矫形器的依从性与接受度。
**研究结果：** 基线时两组间无显著统计学差异（p=0.144–0.882）。与基线水平及对照组相比，干预组在睁眼双足站立测试中，髋部、踝部及身体重心（center-of-mass, COM）摆动幅度在6个月随访时均显著降低（p=0.005~0.040）。干预组内部的跌倒效能感国际量表得分较基线显著降低（p=0.036），步行频次呈上升趋势，效应量中等（d=0.52, p=0.440）。而对照组的跌倒效能感国际量表得分与身体活动指标均无显著变化（p=0.122~0.894）。干预组的身体重心摆动幅度降低与佩戴依从性呈中度负相关（r=-0.484, p=0.047），与基线身体重心摆动幅度呈强负相关（r=-0.903, p<0.001）。
**研究结论：** 结果表明，相较于仅佩戴步行鞋，佩戴双侧定制式踝足矫形器搭配步行鞋可有效改善老年人平衡能力，且能显著降低跌倒恐惧程度；与基线相比，身体活动水平虽无统计学显著差异，但呈现出可观的正向提升趋势。此外，基线平衡能力较差、日常佩戴踝足矫形器依从性更高的老年人，从该干预中获益更为显著。