FREEHAB: accessible, comfortable and adaptable wearable rehabilitation and assist devices

目前，英国有超过1080万残疾人。近650万人有行动障碍。这些数字随着人口年龄中位数的增加而增加，由于肌肉骨骼和神经系统疾病（如关节炎和中风）而导致的与年龄相关的流动性问题变得更加普遍。康复帮助人们提高和保持日常生活中的能力，但目前患者的治疗效果受到两方面的阻碍：首先，缺乏易于使用的动态工具来帮助治疗师准确分析患者的步态和移动性能，并设计最有效的个性化训练和康复计划。其次，随着越来越多的康复发生在家里，需要患者在没有治疗师的情况下练习，需要更好的方法来支持家庭活动和训练，使患者能够在日常活动任务中发挥潜力。FREEHAB医疗保健影响合作伙伴关系将开发柔软的可穿戴康复设备，以直接满足这些需求。FREEHAB将建立在我们之前的EPSRC右裤项目的基础上，在该项目中，我们发现了可以像人造肌肉一样使用的新软材料。这些包括3D可打印的电活性凝胶材料和柔软但坚固的气动链，它们在充气时会改变形状，并可以施加相当大的力。这些材料将用于开发帮助人们行走、站立和从坐着到站着的设备。结合集成传感技术，我们将制造物理治疗师可以使用的设备，以准确地确定患者运动的限制，从而使他们能够计划个性化的训练计划。我们还将制作更简单的设备，患者可以使用这些设备来增强他们的活动能力，并在治疗师不在场的情况下自信地进行锻炼。为此，我们将与NHS服务和私人诊所的物理治疗师合作，与那些亲自经历过物理治疗的人合作，以及在将康复和辅助技术设备从概念推向市场方面经验丰富的商业伙伴。我们将首先确定在设计和开发器械时需要考虑的患者和临床因素。在设备开发过程中，我们将不断咨询合作伙伴的想法和意见。我们将规划FREEHAB技术如何从研究和开发到临床试验的进展，并在项目结束后将设备带入供应链。这将在我们的临床和业务合作伙伴的建议下进行，并涉及NHS使用的器械监管和商业化的知识产权。当我们设计和制造了我们的原型设备后，我们将对其进行测试，以确定物理治疗师如何发现它们对评估有用，以及患者如何发现它们对进行物理治疗训练和康复有用。我们将收集他们的意见，以及正式测量患者佩戴设备时的表现与使用传统矫形支具时的表现相比。我们将确保我们有正确的监管和道德批准的概念测试的早期证明。我们的评估结果将帮助我们为下一阶段的产品开发和临床测试做好准备，这些测试是将设备投入NHS使用所必需的。

There are over 10.8 million disabled people living in the UK today. Nearly 6.5 million have mobility impairments. These numbers are growing as the median population age increases and age-related mobility issues due to musculoskeletal and neurological conditions such as arthritis and stroke, become more prevalent. Rehabilitation helps people improve and maintain their abilities in everyday life, but currently patient outcomes are hampered in two ways: Firstly, there is a lack of easy to use dynamic tools to help therapists to accurately analyse their patients' gait and mobility performance and devise the most effective personalised training and rehabilitation programmes. Secondly, as more and more rehabilitation occurs at home and requires patients to practice in the absence of a therapist, better ways to support in-home mobility and training are needed, to enable patients to achieve their potential in everyday mobility tasks. The FREEHAB Healthcare Impact Partnership will develop soft wearable rehabilitative devices to directly address these needs. FREEHAB will build on discoveries from our previous EPSRC Right Trousers project in which we discovered new soft materials that can be used like artificial muscles. These include 3D printable electroactive gel materials and soft, but strong, pneumatic chains that change they shape when inflated and can exert considerable forces. These materials will be used to develop devices to help people to walk, stand and to move from sitting to standing. Together with integrated sensing technology we will make devices that physiotherapists can use to accurately pinpoint limitations in their patients' movements, thus enabling them to plan personalised training programmes. We will also make simpler devices that the patient can use to enhance their mobility activities and exercises with confidence when a therapist is not with them.To do this we will work in partnership with physiotherapists in NHS services and in private practice, with people who have personally experienced physiotherapy for their mobility problems, and with business partners who are experienced in bringing rehabilitation and assistive technology devices through from concept to market. We will initially determine what patient and clinical considerations we need to take into account to design and develop the devices. We will continually consult with partners for their ideas and opinions as the devices are developed. We will plan how FREEHAB technologies will progress from research and development through translation into clinical trials, and to bring the devices into the supply chain after the project is over. This will be undertaken with advice from our clinical and business partners and with regard to regulation of devices for use in the NHS and intellectual property for commercialisation. When we have designed and manufactured our prototype devices we will test them to determine how physiotherapists find them useful for assessment and how patients find them comfortable and useful for carrying out their physiotherapy training and rehabilitation. We will collect their views alongside formal measurements of patients' performance when they are wearing the devices compared to their performance when using a conventional orthotic brace. We will ensure we have the right regulatory and ethical approval for this early proof of concept testing. The results of our evaluations will help us to prepare for the next stages in product development and clinical testing needed to bring the devices into use in the NHS.