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

今天，英国有超过1080万残疾人。近650万人行动不便。随着人口年龄中位数的增加，以及由于肌肉骨骼和神经疾病(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，这些数字正在增长。康复帮助人们改善和保持他们在日常生活中的能力，但目前患者的预后受到两个方面的阻碍：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活动表现，并设计出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在家中进行，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居家活动和培训，使患者能够在日常活动任务中发挥潜力。FREEHAB Healthcare Impact合作伙伴关系将开发软可穿戴康复设备，以直接满足这些需求。FREEHAB将建立在我们之前的EPSRC右裤子项目的发现基础上，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条，充气时会改变形状，并可以施加相当大的力。这些材料将被用来开发帮助人们行走、站立和从坐到站的设备。与集成的传感技术一起，我们将制造出物理治疗师可以用来准确定位患者行动限制的设备，从而使他们能够计划个性化的培训计划。我们还将制造更简单的设备，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，与亲身经历过行动不便的物理治疗的人合作，并与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合作伙伴合作。我们将初步确定在设计和开发设备时需要考虑哪些患者和临床因素。随着设备的开发，我们将继续与合作伙伴协商他们的想法和意见。我们将规划FREEHAB技术将如何从研发到临床试验的转化，并在项目结束后将这些设备带入供应链。这将与我们的临床和商业合作伙伴以及关于NHS使用的设备的监管和用于商业化的知识产权有关的建议一起进行。当我们设计和制造了我们的原型设备后，我们将对它们进行测试，以确定物理治疗师如何认为它们对评估有用，以及患者如何认为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，并对患者佩戴该设备时的表现与使用传统矫形器时的表现进行正式测量。我们将确保我们对这一早期概念验证测试获得正确的监管和道德批准。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准备，这些测试是将设备投入NHS使用所需的。

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.