Title: A practical, yet flexible functional electrical stimulation system for upper limb functional rehabilitation
Funder: Department of Health (England)

Abstract: As explained in Aims and Objectives , the work can be broken down into late stage activities (WP 1-4 below) and an early stage activity (WP5). The associated deliverables are listed under Success Criteria in the Management and Governance section. WP1 – Hardware development (months 1-21) Following a design review, we will produce an updated system specification, including a plan for software quality assurance. Other sensor modalities: New body-worn sensor units will be designed to capture electromyographic (EMG) signals, and generic analogue/digital inputs. A small number of instrumented, wirelessly connected objects will also be developed for grip monitoring. Repackaging: The current hardware uses off-the-shelf enclosures and, hence, by changing to custom moulded enclosures we hope to achieve significant reductions in size and weight. Donning: Special garments will be designed to make donning of electrodes and sensors quicker and easier. Integration: To maximise commercial viability the designs will be revisited to ensure compatibility with and standardisation across the range of current and future OML products. CE marking: Documentation demonstrating design compliance with the Medical Device Directive will be submitted to MHRA prior to WP4c (month 20). WP2 – Setup GUI development (months 1-18) Improve usability: We will improve the usability of the setup GUI based on the lessons learnt during the usability testing of the research prototype (in our NEAT L030 project). Standard library: Based on the experience gained during the 2 hospital trials with the current research prototype, we will create a standard library of FES supported upper limb tasks so that therapists don’t have to start from scratch. Session manager: We will create a session manager that allows therapists to select a small set of tasks that are then sequenced automatically, either randomly to provide varied practise or to gradually increase difficulty. WP3 – Biofeedback (months 1-18) Together with our existing wireless movement sensors, the new sensor hardware described above will capture arm, trunk and hand movements, EMG signals and grip force during the performance of simple tasks. We will use this data to derive and present biofeedback measures on key aspects of task performance. WP4 – Usability in clinic settings and clinical feasibility study (months 1-30) a) From months 1-18 we will focus on using the methods established in our early stage project to assess the usability of the new hardware and software, as they emerge, with both therapists (setup) and patients (biofeedback) being the users. b) From months 1-15 we will undertake preparatory work for a feasibility study, including mapping the patient journey, estimating therapist staffing requirement, estimating the potentially eligible patient population, and identifying the potential challenges to use of the equipment in hospital and community settings. c) From months 22-30 we will carry out a clinical feasibility study (involving 30 patients) to inform a future clinical trial. Dependent on results, at month 30 a CE mark will be declared under OML’s accreditation for self CE marking of electrical stimulation devices. WP5 – Self-tuning FES control (months 12-30) For a given upper limb task, as the patient improves the FES controller should be adjusted so that the patient must still strive to achieve the goals. At present this is done manually by the therapist; thus requiring their presence during every therapy session. From months 12-24 we will develop adaptive algorithms that automatically adjust FES control parameters in real-time in response to changes in the patient’s performance during the therapy session. Whilst we will investigate generic methods taken from the literature, we believe that bespoke heuristic algorithms may prove to be simpler and more effective. We will evaluate the performance of these algorithms from months 24-30.


Research activity codes: 5.7 PHYSICAL
Health categories: STROKE