Introduction: Of those people who survive a stroke, only between 40 and 70% regain upper limb dexterity. A number of reviews have suggested that functional electrical stimulation (FES) may have a beneficial effect on upper limb motor recovery. In light of the promise offered by FES and the limitations with current systems a new system was developed (FES-UPP) to support people with stroke (PwS) to practice a range of voluntary controlled, FES-assisted functional activities. Objective: This paper reports on a three center clinical investigation with the primary aim of demonstrating compliance of the new FES system with relevant essential requirements of the EU Medical Device Directive, namely to evaluate whether use of the FES-UPP enables PwS to perform a wider range of functional activities, and/or perform the same activities in an improved way. Design: Clinical investigation and feasibility study. Settings: An in-patient stroke unit, a combined Early Supported Discharge (ESD) and community service, and an outpatient clinic and in-patient stroke unit. Participants: Nine therapists and 22 PwS with an impaired upper limb. Intervention: Every PwS was offered up to eight sessions of FES-UPP therapy, each lasting ~1 h, over a period of up to 6 weeks. Primary and secondary outcome measures: The operation, acceptability, and feasibility of the interventions were assessed using video rating and the Wolf Motor Function Test Functional Ability Scale (WMF-FAS), direct observations of sessions and questionnaires for therapists and PwS. Results: The system enabled 24% (Rater A) and 28% (Rater B) of PwS to carry out a wider range of functional tasks and improved the way in which the tasks were performed (mean scores of 2.6 and 2.2 (with FES) vs. mean scores 1.5 and 1.3 (without FES) (p < 0.05). Conclusion: The FES-UP proved feasible to use in three different clinical environments, with PwS who varied widely in their impairment levels and time since stroke. Therapists and therapy assistants from a wide range of backgrounds, with varying degrees of computer and/or FES knowledge, were able to use the system without on-site technical support.
Keywords: clinical investigation; functional activity; functional electrical stimulation; rehabilitation; stroke; upper limb; usability.