Title: Textile electrode cuff to enable FES-assisted walking for users with upper limb impairments
Funder: Department of Health and Social Care

Abstract: Background: Drop foot is a common lower limb disability that affects people s independence and increases the risk of falling. Brain damage caused by neurological disorders (Parkinson's disease (PD), stroke, multiple sclerosis (MS)) leads to long term difficulty in walking. The high prevalence of these diseases (UK PD: 145,000, stroke: 1.2 million, MS: 130,000) has a total societal cost to the UK of &pound;29.8 billion/year. Functional electrical stimulation (FES) devices apply electrical impulses to stimulate the muscles that lift the foot using surface electrodes placed around the knee. This improves walking speed and reduces the risk of falling. Accurate positioning of these electrodes is essential to achieve correct movement, and is a challenging task for many patients: it is particularly challenging for patients with upper limb weakness/disability, which is common in neurological disorders. This leads to poor user experience and reduced uptake. To address this challenge, we have developed a textile electrode cuff that is easy to set up and use &ndash; even with hand function limitation. The cuff works with OML s (UK s leading FES manufacturer) stimulator. The aim of the project is to refine the product with three patient groups (PD, stroke, MS) and healthcare professionals and conduct a clinical study to demonstrate the device s performance in assisted walking and improved usability. Design of Project: We will refine the product with FES users and health professional through a series of co-design and test sessions. The participants ability to correctly put on, take off and use the device will be assessed. Feedback from each session will update the product design. A clinical study will be conducted after obtaining NHS ethical approval and after completion of product refinement. Participants will be recruited from PD, stroke, and MS patient groups. After initial set-up and training in clinics, these participants will use the device at home. Gait parameters will be measured, and usability will be assessed using custom questionnaires. Preliminary quality of life data will be collected using standard questionnaires. We will update the product quality management system and technical documentation according to UK/EU Medical Device Regulations to fulfil the requirement for UKCA/CE marking. Patient/public involvement (PPI) with the stroke community has facilitated this study through their support in identifying unmet patient needs and defining product requirements. This project will engage with wider participants (e.g., PD, MS) who will identify further product requirements, review ethical documents (e.g., participant information sheets), and support dissemination activities (e.g., public engagement). Dissemination: Scientific/clinical data will be published through conferences (e.g., RehabWeek) and journals (e.g., Clinical Rehabilitation). Products will be disseminated through OML s FES training course which has access to 2,000 physiotherapists, newsletters, and exhibitions (e.g., Med-Tech Innovation Expo).

Lay abstract: Background: Drop foot is a common lower limb disability that affects people s independence and increases the risk of falling. Brain damage caused by neurological disorders (Parkinson's disease (PD), stroke, multiple sclerosis (MS)) leads to long term difficulty in walking. The high prevalence of these diseases (UK PD: 145,000, stroke: 1.2 million, MS: 130,000) has a total societal cost to the UK of &pound;29.8 billion/year. Functional electrical stimulation (FES) devices apply electrical impulses to stimulate the muscles that lift the foot using surface electrodes placed around the knee. This improves walking speed and reduces the risk of falling. Accurate positioning of these electrodes is essential to achieve correct movement, and is a challenging task for many patients: it is particularly challenging for patients with upper limb weakness/disability, which is common in neurological disorders. This leads to poor user experience and reduced uptake. To address this challenge, we have developed a textile electrode cuff that is easy to set up and use &ndash; even with hand function limitation. The cuff works with OML s (UK s leading FES manufacturer) stimulator. The aim of the project is to refine the product with three patient groups (PD, stroke, MS) and healthcare professionals and conduct a clinical study to demonstrate the device s performance in assisted walking and improved usability. Design of Project: We will refine the product with FES users and health professional through a series of co-design and test sessions. The participants ability to correctly put on, take off and use the device will be assessed. Feedback from each session will update the product design. A clinical study will be conducted after obtaining NHS ethical approval and after completion of product refinement. Participants will be recruited from PD, stroke, and MS patient groups. After initial set-up and training in clinics, these participants will use the device at home. Gait parameters will be measured, and usability will be assessed using custom questionnaires. Preliminary quality of life data will be collected using standard questionnaires. We will update the product quality management system and technical documentation according to UK/EU Medical Device Regulations to fulfil the requirement for UKCA/CE marking. Patient/public involvement (PPI) with the stroke community has facilitated this study through their support in identifying unmet patient needs and defining product requirements. This project will engage with wider participants (e.g., PD, MS) who will identify further product requirements, review ethical documents (e.g., participant information sheets), and support dissemination activities (e.g., public engagement). Dissemination: Scientific/clinical data will be published through conferences (e.g., RehabWeek) and journals (e.g., Clinical Rehabilitation). Products will be disseminated through OML s FES training course which has access to 2,000 physiotherapists, newsletters, and exhibitions (e.g., Med-Tech Innovation Expo).

Research activity codes: 6.3 MEDICAL DEVICES;5.3 MEDICAL DEVICES
Health categories: NEUROLOGICAL;STROKE