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

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.背景：足部问题在老年人群中高发，可能会增加跌倒风险并加重跌倒相关焦虑。踝足矫形器（Ankle-foot orthoses, AFO）已被证实可有效稳定下肢，但该装置在改善平衡能力方面的长期效果，以及其能否助力老年人群提升身体活动水平，目前仍存在争议。 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群平衡能力、跌倒恐惧及身体活动水平的影响。 研究设计：本研究共纳入44名存在跌倒顾虑或跌倒风险的老年受试者，按随机原则分配至对照组（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 27.8±4.8）。干预组受试者获得步行鞋及双侧定制式踝足矫形器，对照组仅获得步行鞋。在基线及6个月随访时，采用经过验证的可穿戴设备评估平衡能力与身体活动水平，使用国际跌倒效能量表（Fall Efficacy Scale-International, FES-I）评估受试者的跌倒恐惧程度；并于6个月随访时通过自报告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）。与基线及对照组相比，干预组受试者在睁眼双足并拢站立状态下，髋部、踝部及重心（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，国际跌倒效能量表得分较基线显著降低（p=0.036），步行回合数呈上升趋势，效应量中等（d=0.52，p=0.440）；而对照组的国际跌倒效能量表得分及身体活动指标均无显著变化（p=0.122–0.894）。干预组受试者的重心摆动降低幅度与佩戴依从性呈中度相关（r=–0.484，p=0.047），与基线重心摆动幅度呈强相关（r=–0.903，p<0.001）。 研究结论：结果表明，相较于单独佩戴步行鞋，佩戴双侧定制式踝足矫形器联合步行鞋可有效改善老年人群的平衡能力，并显著降低跌倒恐惧程度；同时身体活动水平虽无统计学显著性，但呈现出明显的正向提升趋势，且优于基线水平。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受试者，可从该干预中获得更多收益。