Comfortably numb? Experiences of people with stroke and lower limb sensation deficits: impact and solutions.

PURPOSE: To explore personal experiences of loss of foot sensation following stroke in order to inform the focus of clinical assessments and development of a vibrotactile insole. METHODS: Qualitative design with an interpretive phenomenological approach to data collection and analysis. Eight community dwelling adults with stroke (>6 months) and sensory impairment in the feet participated. Data was collected via conversational style interviews which were transcribed and analyzed using a thematic framework. Themes were verified with co-researchers and a lay advisory group. RESULTS: Data formed four themes: Sensory deficits are prevalent and constant, but individual and variable; Sensory deficits have a direct impact on balance, gait, mobility and falls; Sensory deficits have consequences for peoples' lives; Footwear is the link between function, the environment and identity. They embraced the concept of discrete vibrotactile insoles, their potential benefits and demonstrated a willingness to try it. CONCLUSIONS: Sensory deficit contributes to effects upon physical function, mobility and activity. Clinical outcome measures need to capture the emotional, psychological and social impacts of sensory deficit. Participants demonstrated a resilience and resourcefulness through adaption in daily living and self-management of footwear. The participants focus on footwear provides the opportunity to develop discrete and non-burdensome vibrotactile insoles for this patient group.IMPLICATIONS FOR REHABILITATIONSensory deficits are wide ranging and varied and are not distinct from motor deficits though contribute to the overall effect on physical function, mobility and activity.The physical effects impact on participants' lives emotionally, psychologically and socially. Measurement of outcomes need to capture specific activities that are valued by patients.The participants have revealed resilience and resourcefulness to create a "new normal" for their lives through adaption and self-management with a focus being on footwear as a solution.The participants have revealed the need for insole interventions to be discreet and non-burdensome, welcoming insole technology and contributing to the design and features of such insoles.

A Three-Site Clinical Feasibility Study of a Flexible Functional Electrical Stimulation System to Support Functional Task Practice for Upper Limb Recovery in People With Stroke.

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.

FES-UPP: A Flexible Functional Electrical Stimulation System to Support Upper Limb Functional Activity Practice.

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.

Prediction of setup times for an advanced upper limb functional electrical stimulation system.

INTRODUCTION: Rehabilitation devices take time to don, and longer or unpredictable setup time impacts on usage. This paper reports on the development of a model to predict setup time for upper limb functional electrical stimulation. METHODS: Participants' level of impairment (Fugl Meyer-Upper Extremity Scale), function (Action Research Arm Test) and mental status (Mini Mental Scale) were measured. Setup times for each stage of the setup process and total setup times were recorded. A predictive model of setup time was devised using upper limb impairment and task complexity. RESULTS: Six participants with stroke were recruited, mean age 60 (±17) years and mean time since stroke 9.8 (±9.6) years. Mean Fugl Meyer-Upper Extremity score was 31.1 (±6), Action Research Arm Test 10.4 (±7.9) and Mini Mental Scale 26.1 (±2.7). Linear regression analysis showed that upper limb impairment and task complexity most effectively predicted setup time (51% as compared with 39%) (F(2,21) = 12.782, adjusted R2 = 0.506; p < .05). CONCLUSIONS: A model to predict setup time based on upper limb impairment and task complexity accounted for 51% of the variation in setup time. Further studies are required to test the model in real-world settings and to identify other contributing factors.

A novel method of using accelerometry for upper limb FES control.

This paper reports on a novel approach to using a 3-axis accelerometer to capture body segment angle for upper limb functional electrical stimulation (FES) control. The approach calculates the angle between the accelerometer x-axis and the gravity vector, while avoiding poor sensitivity at certain angles and minimizing errors when true acceleration is relatively large in comparison to gravity. This approach was incorporated into a state-machine controller which is used for the real-time control of FES during upper limb functional task performance. An experimental approach was used to validate the new method. Two participants with different upper limb impairments resulting from a stroke carried out four different FES-assisted tasks. Comparisons were made between angle calculated from arm-mounted accelerometer data using our algorithm and angle calculated from limb-mounted reflective marker data. After removal of coordinate misalignment error, mean error across tasks and subjects ranged between 1.4 and 2.9°. The approach shows promise for use in the control of upper limb FES and other human movement applications where true acceleration is relatively small in comparison with gravity.