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 REHABILITATION Sensory 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 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 up- per 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

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

Initial invasive or conservative strategy for stable coronary disease

BACKGROUND Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain. METHODS We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction. RESULTS Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, 121.8 percentage points; 95% CI, 124.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32). CONCLUSIONS Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used

Health-status outcomes with invasive or conservative care in coronary disease

BACKGROUND In the ISCHEMIA trial, an invasive strategy with angiographic assessment and revascularization did not reduce clinical events among patients with stable ischemic heart disease and moderate or severe ischemia. A secondary objective of the trial was to assess angina-related health status among these patients. METHODS We assessed angina-related symptoms, function, and quality of life with the Seattle Angina Questionnaire (SAQ) at randomization, at months 1.5, 3, and 6, and every 6 months thereafter in participants who had been randomly assigned to an invasive treatment strategy (2295 participants) or a conservative strategy (2322). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate differences between the treatment groups. The primary outcome of this health-status analysis was the SAQ summary score (scores range from 0 to 100, with higher scores indicating better health status). All analyses were performed in the overall population and according to baseline angina frequency. RESULTS At baseline, 35% of patients reported having no angina in the previous month. SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy. Differences were larger among participants who had more frequent angina at baseline (8.5 vs. 0.1 points at 3 months and 5.3 vs. 1.2 points at 36 months among participants with daily or weekly angina as compared with no angina). CONCLUSIONS In the overall trial population with moderate or severe ischemia, which included 35% of participants without angina at baseline, patients randomly assigned to the invasive strategy had greater improvement in angina-related health status than those assigned to the conservative strategy. The modest mean differences favoring the invasive strategy in the overall group reflected minimal differences among asymptomatic patients and larger differences among patients who had had angina at baseline