Title: FREEHAB: accessible, comfortable and adaptable wearable rehabilitation and assist devices
Funder: Engineering and Physical Sciences Research Council

Abstract: 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.

Lay abstract: The FREEHAB Healthcare Impact Partnership is developed from scientific discoveries made on the EPSRC Healthcare Technologies sandpit project: Wearable Soft Robotics for Independent Living (EP/M026388/1, 2015-2018). FREEHAB will address two critical needs in healthcare provision that currently limit the effectiveness and spread of assistive and rehabilitative technologies (ART): 1. The need for effective dynamic physiotherapy assessment tools; and 2. The need for low cost, personalised in-home therapy. FREEHAB will deliver soft, safe and comfortable wearable devices that aid biomechanical diagnosis and provide rehabilitative assistance to train and restore mobility. We aim to develop and evaluate devices that will firstly help the physiotherapist to carry out more precise biomechanical analysis of their patients' performance of mobility tasks and enable more personalised training plans, and secondly enable patients to practice their mobility, with robotic assistance, to achieve more effective at-home rehabilitation. We will focus on the three important functional mobility tasks that elderly and disabled people find difficult: i. Standing, 2. Walking and 3. Transfer (e.g. from sitting to standing) To meet our aims, we define 7 objectives: 1. We will determine precise specification of the design envelope for wearable soft robotic ART devices for walking, standing and transfer. This will be done using participatory design methods with our clinical and patient partners, together with kinematic studies of patient participants' performance of mobility tasks plus studies of physiotherapy practice using talk aloud and video analysis. 2. With industrial and clinical partners, we will establish a translational pipeline that will take soft robotics ART from low-TRL fundamental technologies to healthcare impact and widely available ART products and define a short 1-2 year, medium 3-5 year and long-term 5-10 year translation roadmap for soft robotic ART. 3. We will significantly increase soft actuator capabilities, to enhance the core engineering characteristics compatible with body movement including: i. stress and strain; ii. specific power density; and iii. reliability and safety. This will include investigations into smart materials (e.g. novel dielectric gels for 'dry' Dielectric Liquid Zipping actuation) smart structures (e.g. optimum electrogel materials and 3D structures for higher power density PVC gel actuators), control (e.g. extending proprioception to Bubble Artificial Muscles) and energy (e.g. conversion of hydraulic actuators to electrorheological and dielectrophoretic fluid drive). 4. We will investigate how manufacturability and fabrication costs of the actuators will affect the translation pipeline, including new additive manufacturing methods and more traditional techniques, including roll-to-roll fabrication. 5. We will use an iterative participatory process with clinical and business partners to design devices for in-clinic and at-home assessment and rehabilitation, for standing assist, walking assist, and sit-to-stand. 6. We will evaluate the performance and acceptability of the ART devices against a current comparator device using hard metrics: kinematic and clinical performance, and soft metrics: physiotherapists' and patient participants' views of the acceptability and utility of the devices. 7. As a partnership we will prepare for sustainable impact through exploitation and higher TRL translation and funding, including market analysis, business case development and applications for significant translational funding, and IP protection and spin-out formation. Throughout the project we will obtain ethical and HRA approval for research with NHS patients and therapists, from initial studies needed to obtain specifications for the devices to user evaluation of the final ART devices.

Research activity codes: 4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES;5.3 MEDICAL DEVICES;7.1 INDIVIDUAL CARE NEEDS
Health categories: MUSCULOSKELETAL