双侧定制踝足矫形器预防老年人跌倒的日常使用：一项随机对照试验。
Daily Use of Bilateral Custom-Made Ankle-Foot Orthoses for Fall Prevention in Older Adults: A Randomized Controlled Trial.
机构信息
Interdisciplinary Consortium on Advanced Motion Performance, Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas.
Department of Neuroscience, Baylor College of Medicine, Houston, Texas.
出版信息
J Am Geriatr Soc. 2019 Aug;67(8):1656-1661. doi: 10.1111/jgs.15929. Epub 2019 Apr 24.
OBJECTIVE
To examine the effects of bilateral custom-made ankle-foot orthoses (AFOs) to prevent falls for older adults with concern about or at risk for falling over 12-month daily use.
DESIGN
Secondary analysis of a randomized controlled trial.
SETTING
Community-dwelling older adults.
INTERVENTION
Half of the participants were randomly allocated to an intervention group (IG) that received fitted walking shoes and bilateral custom-made AFOs, and the other half were randomly allocated to a control group (CG) that only received fitted walking shoes.
MEASUREMENTS
Self-reported fall history of 12-month duration was investigated at baseline and 12-month follow-up for both groups. Fall incidence rate and proportion of fallers were used as outcome measures to determine effects of 12-month footwear intervention in either group.
PARTICIPANTS
Adults aged 65 years and older with concern about or at risk for falling (n = 44).
RESULTS
No significant between-group differences in participant characteristics were observed at the baseline (P = .144-.882). Within the IG, significant reductions were found in the fall incidence rate (P = .039) and the proportion of fallers (P = .036) at the 12-month follow-up compared to the baseline. Within the CG, no significant change was found at the 12-month follow-up compared to the baseline for the fall incidence rate (P = .217) or the proportion of fallers (P = .757). When comparing the IG with the CG, there was no significant difference in the change from the baseline to the 12-month follow-up for the fall incidence rate (P = .572) or the proportion of fallers (P = .080).
CONCLUSION
This study failed to demonstrate a significant benefit of bilateral custom-made AFOs to reduce falls compared to fitted walking shoes. However, the AFO users had significant reductions in falls compared to the preceding year. A future study with a larger sample size is recommended to confirm these observations. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT02819011. J Am Geriatr Soc 67:1656-1661, 2019.
目的
探讨双侧定制踝足矫形器（AFO）在预防 12 个月日常使用后对有跌倒担忧或有跌倒风险的老年人跌倒的效果。
设计
随机对照试验的二次分析。
地点
社区居住的老年人。
干预
参与者被随机分为干预组（IG）和对照组（CG）。IG 组接受定制的步行鞋和双侧定制 AFO，CG 组仅接受定制的步行鞋。
测量
在基线和 12 个月随访时，调查两组 12 个月的跌倒史。跌倒发生率和跌倒者比例作为衡量两组 12 个月鞋类干预效果的指标。
参与者
年龄在 65 岁及以上、有跌倒担忧或有跌倒风险的成年人（n=44）。
结果
两组基线时参与者特征无显著差异（P=0.144-0.882）。IG 组在 12 个月随访时，跌倒发生率（P=0.039）和跌倒者比例（P=0.036）显著降低。CG 组在 12 个月随访时，跌倒发生率（P=0.217）和跌倒者比例（P=0.757）与基线相比无显著变化。IG 组与 CG 组相比，12 个月随访时跌倒发生率（P=0.572）和跌倒者比例（P=0.080）的变化无显著差异。
结论
与穿合适的步行鞋相比，本研究未能证明双侧定制 AFO 能显著减少跌倒。然而，AFO 使用者的跌倒次数较前一年显著减少。建议进行一项具有更大样本量的未来研究，以证实这些观察结果。临床试验注册网址：http://www.clinicaltrials.gov。独特标识符：NCT02819011。J Am Geriatr Soc 67：1656-1661，2019。
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