Functional electrical stimulation versus ankle foot orthoses for foot-drop: a meta-analysis of orthotic effects

Objective: To compare the effects on walking of Functional Electrical Stimulation (FES) and Ankle Foot Orthoses (AFO) for foot-drop of central neurological origin, assessed in terms of unassisted walking behaviours compared with assisted walking following a period of use (combined-orthotic effects). Data Sources: MEDLINE, AMED, CINAHL, Cochrane Central Register of Controlled Trials, Scopus, REHABDATA, PEDro, NIHR Centre for Reviews and Dissemination and clinicaltrials.gov. plus reference list, journal, author and citation searches. Study Selection: English language comparative Randomised Controlled Trials (RCTs). Data Synthesis: Seven RCTs were eligible for inclusion. Two of these reported different results from the same trial and another two reported results from different follow up periods so were combined; resulting in five synthesised trials with 815 stroke participants. Meta-analyses of data from the final assessment in each study and three overlapping time-points showed comparable improvements in walking speed over ten metres (p=0.04-0.95), functional exercise capacity (p=0.10-0.31), timed up-and-go (p=0.812 and p=0.539) and perceived mobility (p=0.80) for both interventions. Conclusion: Data suggest that, in contrast to assumptions that predict FES superiority, AFOs have equally positive combined-orthotic effects as FES on key walking measures for foot-drop caused by stroke. However, further long-term, high-quality RCTs are required. These should focus on measuring the mechanisms-of-action; whether there is translation of improvements in impairment to function, plus detailed reporting of the devices used across diagnoses. Only then can robust clinical recommendations be made

Functional electrical stimulation and ankle foot orthoses provide equivalent therapeutic effects on foot drop: A meta-analysis providing direction for future research

Objective: To compare the randomized controlled trial evidence for therapeutic effects on walking of functional electrical stimulation and ankle foot orthoses for foot drop caused by central nervous system conditions. Data sources: MEDLINE, CINAHL, Cochrane Central Register of Controlled Trials, REHABDATA, PEDro, NIHR Centre for Reviews and Dissemination, Scopus and clinicaltrials.gov. Study selection: One reviewer screened titles/abstracts. Two independent reviewers then screened the full articles. Data extraction: One reviewer extracted data, another screened for accuracy. Risk of bias was assessed by 2 independent reviewers using the Cochrane Risk of Bias Tool. Data synthesis: Eight papers were eligible; 7 involving participants with stroke and 1 involving participants with cerebral palsy. Two papes reporting different measures from the same trial were grouped, resulting in 7 synthesized randomized controlled trials (n= 464). Meta-analysis of walking speed at final assessment (p = 0.46), for stroke participants (p = 0.54) and after 4–6 weeks’ use (p = 0.49) showed equal improvement for both devices. Conclusion: Functional electrical stimulation and ankle foot orthoses have an equally positive therapeutic effect on walking speed in non-progressive central nervous system diagnoses. The current randomized controlled trial evidence base does not show whether this improvement translates into the user’s own environment or reveal the mechanisms that achieve that change. Future studies should focus on measuring activity, muscle activity and gait kinematics. They should also report specific device details, capture sustained therapeutic effects and involve a variety of central nervous system diagnoses

Skill assessment in upper limb myoelectric prosthesis users: Validation of a clinically feasible method for characterising upper limb temporal and amplitude variability during the performance of functional tasks

Upper limb myoelectric prostheses remain challenging to use and are often abandoned. A proficient user must be able to plan/execute arm movements while activating the residual muscle(s), accounting for delays and unpredictability in prosthesis response. There is no validated, low cost measure of skill in performing such actions. Trial-trial variability of joint angle trajectories measured during functional task performance, linearly normalised by time, shows promise. However, linear normalisation of time introduces errors, and expensive camera systems are required for joint angle measurements. This study investigated whether trial-trial variability, assessed using dynamic time warping (DTW)of limb segment acceleration measured during functional task performance, is a valid measure of user skill. Temporal and amplitude variability of forearm accelerations were determined in 1) seven myoelectric prosthesis users and six anatomically-intact controls and 2) seven anatomically-intact subjects learning to use a prosthesis simulator over repeated sessions. 1: temporal variability showed clear group differences (p<0.05). 2: temporal variability considerably increased on first use of a prosthesis simulator, then declined with training (both p<0.05). Amplitude variability showed less obvious differences. Analysing forearm accelerations using DTW appears to be a valid low-cost method for quantifying movement quality of upper limb prosthesis use during goal-oriented task performance

The design, development and evaluation of an array-based FES system with automated setup for the correction of drop foot

Functional electrical stimulation has been shown to be a safe and effective means of correcting drop foot of central neurological origin. However, despite recent technological advances, the set-up of surface stimulators remains a challenge for many users with drop foot. The automation of the setup process through the use of electrode arrays has been proposed as a way to address this problem. This paper describes a series of research and clinical studies which have led to the first demonstration of unsupervised automated setup of an electrode-array based drop foot stimulator. Finally, future research plans are discussed

A review of the design and clinical evaluation of the ShefStim array-based functional electrical stimulation system

Functional electrical stimulation has been shown to be a safe and effective means of correcting foot 12 drop of central neurological origin. Current surface-based devices typically consist of a single channel stimulator, 13 a sensor for determining gait phase and a cuff, within which is housed the anode and cathode. The cuff-mounted 14 electrode design reduces the likelihood of large errors in electrode placement, but the user is still fully responsible 15 for selecting the correct stimulation level each time the system is donned. Researchers have investigated different 16 approaches to automating aspects of setup and/or use, including recent promising work based on iterative learning 17 techniques. This paper reports on the design and clinical evaluation of an electrode array-based FES system for 18 the correction of drop foot, ShefStim. The paper reviews the design process from proof of concept lab-based study, 19 through modelling of the array geometry and interface layer to array search algorithm development. Finally, the 20 paper summarises two clinical studies involving patients with drop foot. The results suggest that the ShefStim 21 system with automated setup produces results which are comparable with clinician setup of conventional systems. 22 Further, the final study demonstrated that patients can use the system without clinical supervision. When used 23 unsupervised, setup time was 14 minutes (9 minutes for automated search plus 5 minutes for donning the 24 equipment), although this figure could be reduced significantly with relatively minor changes to the design

Movement variability in stroke patients and controls performing two upper limb functional tasks: a new assessment methodology

Background: In the evaluation of upper limb impairment post stroke there remains a gap between detailed kinematic analyses with expensive motion capturing systems and common clinical assessment tests. In particular, although many clinical tests evaluate the performance of functional tasks, metrics to characterise upper limb kinematics are generally not applicable to such tasks and very limited in scope. This paper reports on a novel, user-friendly methodology that allows for the assessment of both signal magnitude and timing variability in upper limb movement trajectories during functional task performance. In order to demonstrate the technique, we report on a study in which the variability in timing and signal magnitude of data collected during the performance of two functional tasks is compared between a group of subjects with stroke and a group of individually matched control subjects. Methods: We employ dynamic time warping for curve registration to quantify two aspects of movement variability: 1) variability of the timing of the accelerometer signals' characteristics and 2) variability of the signals' magnitude. Six stroke patients and six matched controls performed several trials of a unilateral ('drinking') and a bilateral ('moving a plate') functional task on two different days, approximately 1 month apart. Group differences for the two variability metrics were investigated on both days. Results: For 'drinking from a glass' significant group differences were obtained on both days for the timing variability of the acceleration signals' characteristics (p = 0.002 and p = 0.008 for test and retest, respectively); all stroke patients showed increased signal timing variability as compared to their corresponding control subject. 'Moving a plate' provided less distinct group differences. Conclusion: This initial application establishes that movement variability metrics, as determined by our methodology, appear different in stroke patients as compared to matched controls during unilateral task performance ('drinking'). Use of a user-friendly, inexpensive accelerometer makes this methodology feasible for routine clinical evaluations. We are encouraged to perform larger studies to further investigate the metrics' usefulness when quantifying levels of impairment

Co-creation and user perspectives for upper limb prosthetics

People who either use an upper limb prosthesis and/or have used services provided by a prosthetic rehabilitation centre, experience limitations of currently available prosthetic devices. Collaboration between academia and a broad range of stakeholders, can lead to the development of solutions that address peoples' needs. By doing so, the rate of prosthetic device abandonment can decrease. Co-creation is an approach that can enable collaboration of this nature to occur throughout the research process. We present findings of a co-creation project that gained user perspectives from a user survey, and a subsequent workshop involving: people who use an upper limb prosthesis and/or have experienced care services (users), academics, industry experts, charity executives, and clinicians. The survey invited users to prioritise six themes, which academia, clinicians, and industry should focus on over the next decade. The prioritisation of the themes concluded in the following order, with the first as the most important: function, psychology, aesthetics, clinical service, collaboration, and media. Within five multi-stakeholder groups, the workshop participants discussed challenges and collaborative opportunities for each theme. Workshop groups prioritised the themes based on their discussions, to highlight opportunities for further development. Two groups chose function, one group chose clinical service, one group chose collaboration, and another group chose media. The identified opportunities are presented within the context of the prioritised themes, including the importance of transparent information flow between all stakeholders; user involvement throughout research studies; and routes to informing healthcare policy through collaboration. As the field of upper limb prosthetics moves toward in-home research, we present co-creation as an approach that can facilitate user involvement throughout the duration of such studies

Localisation and Function of the Endocannabinoid System in the Human Ovary

Although anandamide (AEA) had been measured in human follicular fluid and is suggested to play a role in ovarian follicle and oocyte maturity, its exact source and role in the human ovary remains unclear.Immunohistochemical examination of normal human ovaries indicated that the endocannabinoid system was present and widely expressed in the ovarian medulla and cortex with more intense cannabinoid receptor 2 (CB2) than CB1 immunoreactivity in the granulosa cells of primordial, primary, secondary, tertiary follicles, corpus luteum and corpus albicans. The enzymes, fatty acid amide hydrolase (FAAH) and N-acyclphosphatidylethanolamine-phospholipase D (NAPE-PLD), were only found in growing secondary and tertiary follicles and corpora lutea and albicantes. The follicular fluid (FF) AEA concentrations of 260 FF samples, taken from 37 infertile women undergoing controlled ovarian hyperstimulation for in vitro fertilisation and intracytoplasmic sperm injection with embryo transfer, were correlated with ovarian follicle size (P = 0.03). Significantly higher FF AEA concentrations were also observed in mature follicles (1.43+/-0.04 nM; mean+/-SEM) compared to immature follicles (1.26+/-0.06 nM), P = 0.0142 and from follicles containing morphologically assessed mature oocytes (1.56+/-0.11 nM) compared to that containing immature oocytes (0.99+/-0.09 nM), P = 0.0011. ROC analysis indicated that a FF AEA level of 1.09 nM could discriminate between mature and immature oocytes with 72.2% sensitivity and 77.14% specificity, whilst plasma AEA levels and FF AEA levels on oocyte retrieval day were not significantly different (P = 0.23).These data suggest that AEA is produced in the ovary, is under hormonal control and plays a role in folliculogenesis, preovulatory follicle maturation, oocyte maturity and ovulation