Department of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil.
Department of Physical Therapy, Federal University of Amapá, Macapá, Amapá, Brazil.
Trials. 2020 Feb 13;21(1):180. doi: 10.1186/s13063-020-4115-8.
This study is a part of a series of two clinical trials. We consider diabetic polyneuropathy (DPN), a common chronic and progressive complication of diabetes mellitus that has several impacts on individuals' foot health and quality of life. Based on the current trends of self-monitoring and self-care, providing a tool with foot-related exercises and educational care may help patients to avoid or reduce the musculoskeletal complications resulting from DPN, improving autonomous performance in daily living tasks. The aim of this trial is to evaluate the effects of an educational booklet for foot care and foot muscle strengthening on DPN symptoms and severity, clinical outcomes, and gait biomechanics in patients with DPN.
METHODS/DESIGN: The FOotCAre (FOCA) trial II study has been designed as a single-blind, two-parallel-arm randomized controlled trial. It will include 48 patients with DPN who will be randomly allocated to a control (recommended foot care by international consensus with no foot exercises) group or an intervention (foot-related exercises using an educational booklet three times/week at home for 8 weeks) group. Participants from both groups will be assessed at baseline, after 8 weeks, and at 16 weeks for follow-up. The primary outcomes are the DPN symptoms and severity, and the secondary outcomes are foot-ankle kinematics, gait kinetics, plantar pressure distribution during gait, tactile and vibratory sensitivities, foot strength, functional balance, and foot health and functionality.
The booklet is a management tool that allows users to be autonomous in their treatment by choosing how and where to perform the exercises. This allows the patients to perform the exercises regularly as a continuous habit for foot care and health, which is an important element in the management of the diabetic foot. As the booklet focuses on specific foot-ankle exercises, we expect that it will improve the clinical aspects of DPN and produce beneficial biomechanical changes during gait, becoming a powerful self-management tool that can be easily implemented to improve the performance of daily living tasks.
ClinicalTrials.gov, NCT04008745. Registered on 2 July 2019.
本研究是两项临床试验系列研究之一。我们考虑糖尿病周围神经病变（DPN），这是一种常见的糖尿病慢性进行性并发症，会对个人足部健康和生活质量产生多方面影响。基于目前的自我监测和自我护理趋势，提供一种包含足部相关运动和教育护理的工具可能有助于患者避免或减少 DPN 引起的肌肉骨骼并发症，提高日常生活任务的自主能力。本试验的目的是评估足部护理和足部肌肉强化教育手册对 DPN 症状和严重程度、临床结局和 DPN 患者步态生物力学的影响。
方法/设计：FOotCAre（FOCA）试验 II 研究设计为单盲、两平行臂随机对照试验。它将包括 48 例 DPN 患者，他们将被随机分配到对照组（国际共识推荐的足部护理，无足部运动）或干预组（在家中每周三次使用教育手册进行足部相关运动，持续 8 周）。两组参与者均在基线、8 周后和 16 周随访时进行评估。主要结局是 DPN 症状和严重程度，次要结局是足踝运动学、步态动力学、步态时的足底压力分布、触觉和振动觉敏感度、足部力量、功能性平衡以及足部健康和功能。
该手册是一种管理工具，允许使用者通过选择如何和在哪里进行运动来自主治疗。这使得患者可以定期进行运动，将其作为足部护理和健康的持续习惯，这是糖尿病足管理的重要因素。由于该手册专注于特定的足踝运动，我们预计它将改善 DPN 的临床方面，并在步态期间产生有益的生物力学变化，成为一种强大的自我管理工具，可轻松实施以改善日常生活任务的表现。
ClinicalTrials.gov，NCT04008745。于 2019 年 7 月 2 日注册。
