A 6-Month Home-Based Functional Electrical Stimulation Program for Foot Drop in a Post-Stroke Patient: Considerations on a Time Course Analysis of Walking Performance.

Foot drop is a common disability in post-stroke patients and represents a challenge for the clinician. To date, ankle foot orthosis (AFO) combined with conventional rehabilitation is the gold standard of rehabilitation management. AFO has a palliative mechanical action without actively restoring the associated neural function. Functional electrical stimulation (FES), consisting of stimulation of the peroneal nerve pathway, represents an alternative approach. By providing an FES device (Bioness L-300, BIONESS, Valencia, CA, USA) for 6 months to a post-stroke 22-year-old woman with a foot drop, our goal was to quantify its potential benefit on walking capacity. The gait parameters and the temporal evolution of the speed were collected with a specific connected sole device (Feet Me®) during the 10-m walking, the time up and go, and the 6-minute walking tests with AFO, FES, or without any device (NO). As a result, the walking speed changes on 10-m were clinically significant with an increase from the baseline to 6 months in AFO (+0.14 m.s-1), FES (+0.36 m.s-1) and NO (+0.32 m.s-1) conditions. In addition, the speed decreased at about 4-min in the 6-minute walking test in NO and AFO conditions, while the speed increased in the FES conditions at baseline and after 1, 3, and 6 months. In addition to the walking performance improvement, monitoring the gait speed in an endurance test after an ecological rehabilitation training program helps to examine the walking performance in post-stroke patients and to propose a specific rehabilitation program.

Trends and Technologies in Rehabilitation of Foot Drop: A Systematic Review.

INTRODUCTION: Foot Drop (FD) is a condition, which is very commonly found in post-stoke patients; however it can also be seen in patients with multiple sclerosis, and cerebral palsy. It is a sign of neuromuscular damage caused by the weakness of the muscles. There are various approaches of FD's rehabilitation, such as physiotherapy, surgery, and the use of technological devices. Recently, researchers have worked on developing various technologies to enhance assisting and rehabilitation of FD. AREAS COVERED: This review analyzes different types of technologies available for FD. This include devices that are available commercially or still under research. 101 studies published between 2015 and 2020 were identified for the review, many were excluded due to various reasons, e.g., were not robot-based devices, did not include FD as one of the targeted diseases, or was insufficient information. 24 studies that met our inclusion criteria were assessed. These studies were further classified into two different categories: robot-based ankle-foot orthosis (RAFO) and Functional Electrical Stimulation (FES) devices. EXPERT OPINION: Studies included showed that both RAFO and FES showed considerable improvement in the gait cycle of the patients. Future trends are inclining towards integrating FES with other neuro-concepts such as muscle-synergies for further developments.

Advances in neuroprosthetic management of foot drop: a review.

This paper reviews the technological advances and clinical results obtained in the neuroprosthetic management of foot drop. Functional electrical stimulation has been widely applied owing to its corrective abilities in patients suffering from a stroke, multiple sclerosis, or spinal cord injury among other pathologies. This review aims at identifying the progress made in this area over the last two decades, addressing two main questions: What is the status of neuroprosthetic technology in terms of architecture, sensorization, and control algorithms?. What is the current evidence on its functional and clinical efficacy? The results reveal the importance of systems capable of self-adjustment and the need for closed-loop control systems to adequately modulate assistance in individual conditions. Other advanced strategies, such as combining variable and constant frequency pulses, could also play an important role in reducing fatigue and obtaining better therapeutic results. The field not only would benefit from a deeper understanding of the kinematic, kinetic and neuromuscular implications and effects of more promising assistance strategies, but also there is a clear lack of long-term clinical studies addressing the therapeutic potential of these systems. This review paper provides an overview of current system design and control architectures choices with regard to their clinical effectiveness. Shortcomings and recommendations for future directions are identified.

Surplus value of implanted peroneal functional electrical stimulation over ankle-foot orthosis for gait adaptability in people with foot drop after stroke.

BACKGROUND: Implanted peroneal functional electrical stimulation (FES) is an effective alternative treatment to ankle-foot orthosis (AFO) in people with drop foot after stroke. With FES no constraints on ankle mobility are imposed which might particularly be exploited in challenging walking environments that require adaptations of the gait pattern to environmental disturbances. RESEARCH QUESTION: Is gait adaptability, by means of the capacity to avoid sudden obstacles while walking on a treadmill, superior with implanted FES compared to AFO in people with drop foot after stroke? METHODS: A 4-channel peroneal nerve stimulator (ActiGait®) was implanted in 22 persons with stroke (>6 months) who regularly used an AFO. Gait adaptability was tested with an obstacle avoidance task on an instrumented treadmill up to 26 weeks (n = 10) or 52 weeks (n = 12) after FES-system activation. At assessments, 30 trials, in which obstacles were suddenly dropped onto the treadmill in front of the paretic leg, were recorded with each device (FES / AFO). Trials were grouped by available response times (ART) and success rates were calculated. The effect of device, ART and follow up time on success rates was tested using generalized estimated equations. Nonparametric correlations were calculated to associate changes in success rates with clinimetrics. RESULTS: Success rates of obstacle avoidance were higher when participants used their FES system compared to AFO (Δ4.7%, p = 0.03), which effect was largest for longest ARTs (Δ15%, p = 0.03). Participants with greater motor impairment of the paretic leg showed greater benefit from FES (rs=-0.49, p = 0.04). SIGNIFICANCE: FES has been found equally effective as AFO in improving walking speed of people with drop foot after stroke. We now present superior walking performance in a complex walking environment for implanted peroneal FES compared to AFO. These findings underline the importance of using gait assessments that require interplay with the environment, besides assessment of stationary walking, in community ambulators.

The clinical- and cost-effectiveness of functional electrical stimulation and ankle-foot orthoses for foot drop in Multiple Sclerosis: a multicentre randomized trial.

OBJECTIVE: To compare the clinical- and cost-effectiveness of ankle-foot orthoses (AFOs) and functional electrical stimulation (FES) over 12 months in people with Multiple Sclerosis with foot drop. DESIGN: Multicentre, powered, non-blinded, randomized trial. SETTING: Seven Multiple Sclerosis outpatient centres across Scotland. SUBJECTS: Eighty-five treatment-naïve people with Multiple Sclerosis with persistent (>three months) foot drop. INTERVENTIONS: Participants randomized to receive a custom-made, AFO (n = 43) or FES device (n = 42). OUTCOME MEASURES: Assessed at 0, 3, 6 and 12 months; 5-minute self-selected walk test (primary), Timed 25 Foot Walk, oxygen cost of walking, Multiple Sclerosis Impact Scale-29, Multiple Sclerosis Walking Scale-12, Modified Fatigue Impact Scale, Euroqol five-dimension five-level questionnaire, Activities-specific Balance and Confidence Scale, Psychological Impact of Assistive Devices Score, and equipment and National Health Service staff time costs of interventions. RESULTS: Groups were similar for age (AFO, 51.4 (11.2); FES, 50.4(10.4) years) and baseline walking speed (AFO, 0.62 (0.21); FES 0.73 (0.27) m/s). In all, 38% dropped out by 12 months (AFO, n = 21; FES, n = 11). Both groups walked faster at 12 months with device (P < 0.001; AFO, 0.73 (0.24); FES, 0.79 (0.24) m/s) but no difference between groups. Significantly higher Psychological Impact of Assistive Devices Scores were found for FES for Competence (P = 0.016; AFO, 0.85(1.05); FES, 1.53(1.05)), Adaptability (P = 0.001; AFO, 0.38(0.97); FES 1.53 (0.98)) and Self-Esteem (P = 0.006; AFO, 0.45 (0.67); FES 1 (0.68)). Effects were comparable for other measures. FES may offer value for money alternative to usual care. CONCLUSION: AFOs and FES have comparable effects on walking performance and patient-reported outcomes; however, high drop-outs introduces uncertainty.

The long-term cost-effectiveness of the use of Functional Electrical Stimulation for the correction of dropped foot due to upper motor neuron lesion.

OBJECTIVE: Functional Electrical Stimulation (FES) for correction of dropped foot has been shown to increase mobility, reduce the incidence of falls and to improve quality of life. This study aimed to determine how long the intervention is of benefit, and the total cost of its provision. DESIGN: Retrospective review of medical records. PARTICIPANTS: One hundred and twenty-six people with spastic dropped foot (62 stroke, 39 multiple sclerosis, 7 spinal cord injury, 3 cerebral palsy, 15 others) who began treatment in the year 1999. METHOD: All received common peroneal nerve stimulation, producing dorsiflexion and eversion time to the swing phase of gait using a heel switch. Device usage, 10 m walking speed and Functional Walking Category (FWC) were recorded. RESULTS: The median time of FES use was 3.6 years (mean 4.9, standard deviation 4.1, 95% confidence interval 4.2-5.6) with 33 people still using FES after a mean of 11.1 years. People with stroke walked a mean of 45% faster overall, including a 24% training effect with 52% improving their FWC. People with multiple sclerosis did not receive a consistent training effect but walked 29% faster when FES was used with 40% increasing their FWC. The average treatment cost was £3,095 per patient resulting in a mean cost per Quality Adjusted Life Years of £15,406. CONCLUSION: FES is a practical, long-term and cost-effective treatment for correction of dropped foot.

The orthotic effect of functional electrical stimulation on the improvement of walking in stroke patients with a dropped foot: a systematic review.

OBJECTIVE: Analysis of the available evidence on the improvement of walking in stroke patients with a dropped foot when using peroneus stimulation. METHODS: A systematic review was performed to identify trials that investigated the orthotic effect of functional electrical stimulation (FES) on walking in stroke patients with a dropped foot. Two independent raters scored the methodological quality of the included articles. Walking speed and physiological cost index (PCI) were selected as the primary outcome measures. Studies that measured walking speed were pooled and a pooled difference including confidence interval was calculated. RESULTS: Eight studies were included in the review, of which one was a randomized controlled trial. Methodological score ranged from 8 to 18 out of 19. Six studies measured walking speed. The pooled improvement in walking speed was 0.13 m/s (0.07-0.2) or 38% (22.18-53.8). CONCLUSIONS: The present review suggests a positive orthotic effect of functional electrical stimulation on walking speed.

Clinical use of the Odstock dropped foot stimulator: its effect on the speed and effort of walking.

OBJECTIVE: To assess the clinical effectiveness of the Odstock dropped foot stimulator by analysis of its effect on physiological cost index (PCI) and speed of walking. This functional electrical stimulation (FES) device stimulates the common peroneal nerve during the swing phase of gait. DESIGN: A retrospective study of patients who had used the device for 4 1/2 months. SUBJECTS: One hundred fifty-one patients with a dropped foot resulting from an upper motor neuron lesion. SETTING: A medical physics and biomedical engineering department of a district general hospital specializing in the clinical application of FES and a neurophysiotherapy department at a separate hospital. MAIN OUTCOME MEASURES: Changes in walking speed and effort of walking, as measured by PCI over a 10-meter course. RESULTS: There was a 92.7% compliance with treatment. Stroke patients showed a mean increase in walking speed of 27% (p<.01) and reduction in PCI of 31% (p<.01) with stimulation, and changes of 14% (p<.01) and 19% (p<.01), respectively, while not using the stimulator. Multiple sclerosis patients gained similar orthotic benefit but no "carry-over." CONCLUSIONS: The measured differences in walking with and without stimulation were statistically significant in the stroke and multiple sclerosis groups. In this study use of the stimulator improved walking. Those with stroke demonstrated a short-term "carry-over" effect.