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首页> 外文期刊>Trials >Study protocol for a randomized controlled trial on the effect of the Diabetic Foot Guidance System (SOPeD) for the prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial I
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Study protocol for a randomized controlled trial on the effect of the Diabetic Foot Guidance System (SOPeD) for the prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial I

机译：用于随机对照试验的研究方案对糖尿病足引导系统（SOPED）预防和治疗患有糖尿病神经病变的脚肌肉骨骼功能障碍的效果：患者（FOCA）试验I

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BACKGROUND:This study is part of a series of two clinical trials. Taking into account the various musculoskeletal alterations of the foot and ankle in people with diabetic peripheral neuropathy (DPN) and the need for self-care to avoid more serious dysfunctions and complications, a self-manageable exercise protocol that focuses on strengthening the foot muscles is presented as a potentially effective preventive method for foot and gait complications. The aim of this trial is to investigate the effect of a customized rehabilitation technology, the Diabetic Foot Guidance System (SOPeD), on DPN status, functional outcomes and gait biomechanics in people with DPN.METHODS/DESIGN:Footcare (FOCA) trial I is a randomized, controlled and parallel two-arm trial with blind assessment. A total of 62 patients with DPN will be allocated into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group (who will perform exercises through SOPeD at home three times a week for 12?weeks). The exercise program will be customized throughout its course by a perceived effort scale reported by the participant after completion of each exercise. The participants will be assessed at three different times (baseline, completion at 12?weeks, and follow-up at 24?weeks) for all outcomes. The primary outcomes will be DPN symptoms and severity classification. The secondary outcomes will be foot-ankle kinematics and kinetic and plantar pressure distribution during gait, tactile and vibration sensitivities, foot health and functionality, foot strength, and functional balance.DISCUSSION:As there is no evidence about the efficacy of rehabilitation technology in reducing DPN symptoms and severity or improving biomechanical, clinical, and functional outcomes for people with DPN, this research can contribute substantially to clarifying the therapeutic merits of software interventions. We hope that the use of our application for people with DPN complications will reduce or attenuate the deficits caused by DPN. This rehabilitation technology is freely available, and we intend to introduce it into the public health system in Brazil after demonstrating its effectiveness.TRIAL REGISTRATION:ClinicalTrials.gov, NCT04011267. Registered on 8 July 2019.
机译：背景：本研究是一系列两种临床试验的一部分。考虑到患有糖尿病外周神经病变（DPN）的人群和脚踝的各种肌肉骨骼改变，并且需要自我保留，以避免更严重的功能障碍和并发症，一种专注于加强脚肌的自由可管理的运动方案呈现为脚踏和步态并发症的潜在有效的预防方法。该试验的目的是调查定制康复技术，糖尿病脚指导系统（SOPED），在DPN的人们对DPN状态，功能性结果和步态生物力学的影响。方法/设计：我是患有足迹（FOCA）审判随机，受控和并行双臂试验，具有盲评估。共有62名DPN患者将分配给对照组（通过国际共识推荐足部护理，没有足够的脚步）或干预组（谁将通过在每周三次在家里进行一次锻炼，12？周）。行使计划将在整个课程中定制，参与者在完成每次锻炼后由参与者报告。参与者将在三次不同的时间评估（基线，在12个星期完成，并在24个星期的后续行动，适用于所有结果。主要结果将是DPN症状和严重性分类。在步态，触觉和振动敏感度，足部健康和功能，脚力量和功能平衡期间，二次结果将是足部脚踝运动学和动力学和动力学和跖骨压力分布。探讨：因为没有证据康复技术在减少中的效果DPN症状和严重程度或改善DP​​N人员的生物力学，临床和功能结果，这项研究可以大大贡献，以澄清软件干预的治疗性能。我们希望利用我们对DPN并发症的人的申请将减少或减少DPN造成的赤字。这种康复技术是自由的，我们打算在展示其有效性后将其介绍到巴西的公共卫生系统.TRIAL注册：ClinicalTrials.gov，NCT04011267。 2019年7月8日注册。

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