RESUMO
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.
RESUMO
There is good evidence supporting highly intensive, repetitive, activity-focused, voluntary-initiated practice as a key to driving recovery of upper limb function following stroke. Functional electrical stimulation (FES) offers a potential mechanism to efficiently deliver this type of therapy, but current commercial devices are too inflexible and/or insufficiently automated, in some cases requiring engineering support. In this paper, we report a new, flexible upper limb FES system, FES-UPP, which addresses the issues above. The FES-UPP system consists of a 5-channel stimulator running a flexible FES finite state machine (FSM) controller, the associated setup software that guides therapists through the setup of FSM controllers via five setup stages, and finally the Session Manager used to guide the patient in repeated attempts at the activities(s) and provide feedback on their performance. The FSM controller represents a functional activity as a sequence of movement phases. The output for each phase implements the stimulations to one or more muscles. Progression between movement phases is governed by user-defined rules. As part of a clinical investigation of the system, nine therapists used the FES-UPP system to set up FES-supported activities with twenty two patient participants with impaired upper-limbs. Therapists with little or no FES experience and without any programming skills could use the system in their usual clinical settings, without engineering support. Different functional activities, tailored to suit the upper limb impairment levels of each participant were used, in up to 8 sessions of FES-supported therapy per participant. The efficiency of delivery of the therapy using FES-UPP was promising when compared with published data on traditional face-face therapy. The FES-UPP system described in this paper has been shown to allow therapists with little or no FES experience and without any programming skills to set up state-machine FES controllers bespoke to the patient's impairment patterns and activity requirements, without engineering support. The clinical results demonstrated that the system can be used to efficiently deliver high intensity, activity-focused therapy. Nevertheless, further work to reduce setup time is still required.
