van Duijnhoven Elza, Waterval Niels Fj, Koopman Fieke Sophia, Esquenazi Alberto, Nollet Frans, Brehm Merel-Anne
Department of Rehabilitation Medicine, Amsterdam UMC, location University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.
Amsterdam Movement Sciences, Rehabilitation & Development, Amsterdam, Netherlands.
Cochrane Database Syst Rev. 2025 Jan 16;1(1):CD014871. doi: 10.1002/14651858.CD014871.pub2.
Calf muscle weakness is a common symptom in slowly progressive neuromuscular disorders that lead to walking problems like instability and increased walking effort. The mainstay of treatment to improve walking in this population is the provision of ankle-foot-orthoses (AFOs). Since we are not aware of an up-to-date and complete overview of the effects of AFOs used for calf muscle weakness in slowly progressive neuromuscular disorders, we reviewed the evidence for the effectiveness of AFOs to improve walking in this patient group, in order to support clinical decision-making.
To review the evidence for the effects of ankle-foot orthoses (AFOs) for improving walking in adults with calf muscle weakness due to slowly progressive neuromuscular disorders.
On 10 February 2023, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, Embase, MEDLINE, ClinicalTrials.gov, and WHO ICTRP.
We looked for randomised controlled trials (RCTs), including randomised cross-over studies and quasi-RCTs, and non-randomised studies (NRSs) that examined the effects of AFO interventions compared with shoes-only walking in adults with calf muscle weakness due to neuromuscular disorders.
We used the methodological procedures described in the Cochrane Handbook for Systematic Reviews of Interventions. We summarised findings for the primary outcome (objectively measured walking effort, assessed as walking energy cost) and secondary outcomes (perceived walking effort, physical mobility, gait parameters, AFO use, satisfaction with the AFO, and adverse events). We grouped results according to the type of AFO material and synthesised them in meta-analysis where possible. We used the GRADE approach to rate the certainty of the evidence.
We included four randomised cross-over studies and six NRSs with 186 participants in total (the smallest study had 8 participants and the largest had 37). All studies were designed as self-controlled studies and examined the effects of custom-made and/or prefabricated AFOs. The AFOs were made of carbon (5 studies), polypropylene (5 studies), silicone (1 study), metal (1 study), elastic materials (2 studies), or leather combined with other materials (1 study). Outcome measures with AFOs were assessed during a single session (in some studies, people already used the study AFO in daily life), when the AFO was delivered, or at three-week or three-month follow-up. We judged one study to be at moderate risk of bias, and nine studies to be at high or serious risk of bias, primarily due to bias arising from period and carryover effects, selection bias, the inability to blind participants and assessors, missing data, and selective reporting. We found that carbon AFOs may reduce walking energy cost (mean difference (MD) -0.86 J/kg/m, 95% confidence interval (CI) -1.33 to -0.39; 2 studies, 45 participants; low-certainty evidence), and may increase walking speed (MD 0.19 m/s, 95% CI 0.11 to 0.27; 4 studies, 71 participants; low-certainty evidence) compared to shoes-only walking. We found that leather AFOs may increase walking speed (MD 0.25 m/s, 95% CI 0.07 to 0.43; 1 study, 11 participants; low-certainty evidence). Little or no effect on walking speed was found with polypropylene AFOs (MD 0.00 m/s, 95% CI -0.11 to 0.11; 2 studies, 25 participants; low-certainty evidence) and elastic AFOs (MD 0.03 m/s, 95% CI -0.12 to 0.18; 1 study, 14 participants; low-certainty evidence). Carbon AFOs may also enhance satisfaction while walking (1 study, 16 participants; low-certainty evidence). We were unable to draw conclusions about perceived walking effort (one study, 8 participants), balance (two studies, 21 participants), and AFO use (two studies, 51 participants), as the evidence is very uncertain. Finally, two studies (45 participants) reported on adverse events (low-certainty evidence).
AUTHORS' CONCLUSIONS: The available evidence for ankle-foot orthoses (AFOs) to improve walking in adults with calf muscle weakness comes from a limited number of small studies with heterogeneity in intervention characteristics and outcome assessment, and is of low to very low certainty. The evidence suggests that carbon AFOs may reduce walking energy cost (effort), increase walking speed, and enhance satisfaction, and leather AFOs may increase walking speed, while polypropylene and elastic AFOs may make little or no difference to walking speed. We are unable to draw conclusions about the effects of AFOs on perceived walking effort, balance, and use. Nor can we draw conclusions about adverse effects of using AFOs. The variety in the findings for AFOs made of different materials suggests further investigation is warranted to explore how different AFO materials impact walking improvement in people with calf muscle weakness due to slowly progressive neuromuscular disorders.
小腿肌肉无力是缓慢进展性神经肌肉疾病的常见症状，会导致行走问题，如不稳和行走费力增加。改善该人群行走能力的主要治疗方法是提供踝足矫形器（AFO）。由于我们尚未掌握关于AFO用于缓慢进展性神经肌肉疾病所致小腿肌肉无力的最新且完整的效果综述，我们对AFO改善该患者群体行走能力的有效性证据进行了综述，以支持临床决策。
综述踝足矫形器（AFO）对改善因缓慢进展性神经肌肉疾病导致小腿肌肉无力的成年人行走能力的效果证据。
2023年2月10日，我们检索了Cochrane神经肌肉专业注册库、CENTRAL、Embase、MEDLINE、ClinicalTrials.gov和世界卫生组织国际临床试验注册平台。
我们查找了随机对照试验（RCT），包括随机交叉研究和半随机对照试验，以及非随机研究（NRS），这些研究比较了AFO干预与仅穿鞋子行走对因神经肌肉疾病导致小腿肌肉无力的成年人的影响。
我们采用了Cochrane干预措施系统评价手册中描述的方法学程序。我们总结了主要结局（客观测量的行走费力程度，以行走能量消耗评估）和次要结局（主观感受的行走费力程度、身体活动能力、步态参数、AFO使用情况、对AFO的满意度以及不良事件）的研究结果。我们根据AFO材料类型对结果进行分组，并在可能的情况下进行Meta分析。我们采用GRADE方法对证据的确定性进行评级。
我们纳入了4项随机交叉研究和6项非随机研究，共186名参与者（最小的研究有8名参与者，最大的有37名）。所有研究均设计为自身对照研究，研究了定制和/或预制AFO的效果。AFO由碳材料（5项研究）、聚丙烯（5项研究）、硅胶（1项研究）、金属（1项研究）、弹性材料（2项研究）或皮革与其他材料组合（1项研究）制成。在单次评估期间（在一些研究中，参与者已在日常生活中使用研究用AFO）、AFO交付时、或在三周或三个月随访时评估使用AFO后的结局指标。我们判定1项研究存在中度偏倚风险，9项研究存在高或严重偏倚风险，主要原因是由于时期和遗留效应、选择偏倚、无法使参与者和评估者设盲、数据缺失以及选择性报告导致的偏倚。我们发现，与仅穿鞋子行走相比，碳AFO可能降低行走能量消耗（平均差（MD）-0.86 J/kg/m，95%置信区间（CI）-1.33至-0.39；2项研究，45名参与者；低确定性证据），并可能提高行走速度（MD 0.19 m/s，95%CI 0.11至0.27；4项研究，71名参与者；低确定性证据）。我们发现，皮革AFO可能提高行走速度（MD 0.25 m/s，95%CI 0.07至0.43；1项研究，11名参与者；低确定性证据）。对于聚丙烯AFO（MD 0.00 m/s，95%CI -0.11至0.11；2项研究，25名参与者；低确定性证据）和弹性AFO（MD 0.03 m/s，95%CI -0.12至0.18；1项研究，14名参与者；低确定性证据），未发现对行走速度有显著影响。碳AFO还可能提高行走时的满意度（1项研究，16名参与者；低确定性证据）。由于证据非常不确定，我们无法就主观感受的行走费力程度（1项研究，8名参与者）、平衡能力（2项研究，21名参与者）和AFO使用情况（2项研究，51名参与者）得出结论。最后，2项研究（45名参与者）报告了不良事件（低确定性证据）。
关于踝足矫形器（AFO）改善小腿肌肉无力成年人行走能力的现有证据来自数量有限的小型研究，干预特征和结局评估存在异质性且确定性低至极低。证据表明，碳AFO可能降低行走能量消耗（费力程度）、提高行走速度并增强满意度，皮革AFO可能提高行走速度，而聚丙烯和弹性AFO对行走速度可能影响很小或无影响。我们无法就AFO对主观感受的行走费力程度、平衡能力和使用情况的影响得出结论。我们也无法就使用AFO的不良反应得出结论。不同材料制成的AFO研究结果存在差异，这表明有必要进一步研究，以探讨不同AFO材料如何影响因缓慢进展性神经肌肉疾病导致小腿肌肉无力的人群的行走改善情况。
