Department of Rehabilitation, Academic Medical Center, University of Amsterdam, Amsterdam Movement Sciences, Amsterdam, The Netherlands.
Department of Rehabilitation Medicine, VU University Medical Center, Amsterdam Movement Sciences, The Netherlands.
BMJ Open. 2017 Feb 28;7(2):e013342. doi: 10.1136/bmjopen-2016-013342.
In patients with neuromuscular disorders and subsequent calf muscle weakness, metabolic walking energy cost (EC) is nearly always increased, which may restrict walking activity in daily life. To reduce walking EC, a spring-like ankle-foot-orthosis (AFO) can be prescribed. However, the reduction in EC that can be obtained from these AFOs is stiffness dependent, and it is unknown which AFO stiffness would optimally support calf muscle weakness. The PROOF-AFO study aims to determine the effectiveness of stiffness-optimised AFOs on reducing walking EC, and improving gait biomechanics and walking speed in patients with calf muscle weakness, compared to standard, non-optimised AFOs. A second aim is to build a model to predict optimal AFO stiffness.
A prospective intervention study will be conducted. In total, 37 patients with calf muscle weakness who already use an AFO will be recruited. At study entry, participants will receive a new custom-made spring-like AFO of which the stiffness can be varied. For each patient, walking EC (primary outcome), gait biomechanics and walking speed (secondary outcomes) will be assessed for five stiffness configurations and the patient's own (standard) AFO. On the basis of walking EC and gait biomechanics outcomes, the optimal AFO stiffness will be determined. After wearing this optimal AFO for 3 months, walking EC, gait biomechanics and walking speed will be assessed again and compared to the standard AFO.
The Medical Ethics Committee of the Academic Medical Centre in Amsterdam has approved the study protocol. The study is registered at the Dutch trial register (NTR 5170). The PROOF-AFO study is the first to compare stiffness-optimised AFOs with usual care AFOs in patients with calf muscle weakness. The results will also provide insight into factors that influence optimal AFO stiffness in these patients. The results are necessary for improving orthotic treatment and will be disseminated through international peer-reviewed journals and scientific conferences.
在患有神经肌肉疾病和随后出现小腿肌无力的患者中，代谢行走能量消耗（EC）几乎总是增加，这可能会限制日常生活中的行走活动。为了降低行走 EC，可以开处方使用类似弹簧的踝足矫形器（AFO）。然而，这些 AFO 可降低的 EC 取决于其刚度，尚不清楚哪种 AFO 刚度最能支撑小腿肌无力。PROOF-AFO 研究旨在确定优化刚度的 AFO 相对于标准非优化 AFO 降低行走 EC、改善步态生物力学和行走速度的效果，在小腿肌无力的患者中。第二个目标是建立一个预测最佳 AFO 刚度的模型。
这将是一项前瞻性干预研究。总共将招募 37 名已使用 AFO 的小腿肌无力患者。在研究开始时，参与者将收到一个新的定制的类似弹簧的 AFO，其刚度可以变化。对于每个患者，将评估五种刚度配置和患者自身（标准）AFO 的行走 EC（主要结果）、步态生物力学和行走速度（次要结果）。根据行走 EC 和步态生物力学结果，将确定最佳 AFO 刚度。佩戴这种最佳 AFO 3 个月后，再次评估行走 EC、步态生物力学和行走速度，并与标准 AFO 进行比较。
阿姆斯特丹学术医学中心的医学伦理委员会已批准该研究方案。该研究已在荷兰试验注册处（NTR 5170）注册。PROOF-AFO 研究是第一项比较小腿肌无力患者的优化刚度 AFO 与常规护理 AFO 的研究。结果还将提供对影响这些患者最佳 AFO 刚度的因素的深入了解。研究结果对于改善矫形治疗是必要的，并将通过国际同行评议期刊和科学会议进行传播。
