Is functional electrical stimulation effective in improving walking in adults with lower limb impairment due to an upper motor neuron lesion? An umbrella review.

PURPOSE: To conduct an umbrella review of systematic reviews on functional electrical stimulation (FES) to improve walking in adults with an upper motor neuron lesion. METHODS: Five electronic databases were searched, focusing on the effect of FES on walking. The methodological quality of reviews was evaluated using AMSTAR2 and certainty of evidence was established through the GRADE approach. RESULTS: The methodological quality of the 24 eligible reviews (stroke, n = 16; spinal cord injury (SCI), n = 5; multiple sclerosis (MS); n = 2; mixed population, n = 1) ranged from critically low to high. Stroke reviews concluded that FES improved walking speed through an orthotic (immediate) effect and had a therapeutic benefit (i.e., over time) compared to usual care (low certainty evidence). There was low-to-moderate certainty evidence that FES was no better or worse than an Ankle Foot Orthosis regarding walking speed post 6 months. MS reviews concluded that FES had an orthotic but no therapeutic effect on walking. SCI reviews concluded that FES with or without treadmill training improved speed but combined with an orthosis was no better than orthosis alone. FES may improve quality of life and reduce falls in MS and stroke populations. CONCLUSION: FES has orthotic and therapeutic benefits. Certainty of evidence was low-to-moderate, mostly due to high risk of bias, low sample sizes, and wide variation in outcome measures. Future trials must be of higher quality, use agreed outcome measures, including measures other than walking speed, and examine the effects of FES for adults with cerebral palsy, traumatic and acquired brain injury, and Parkinson's disease.

A nation-wide survey exploring the views of current and future use of functional electrical stimulation in spinal cord injury.

PURPOSE: Functional electrical stimulation (FES) can be effective in assisting physical and psychosocial difficulties experienced by people with spinal cord injury. Perceived benefits and barriers of the current and future use of FES within the wider spinal cord injury community is currently unknown. The main objective of this research was to explore the spinal cord injury community's views of the use of FES to decrease disability in rehabilitation programmes. MATERIALS AND METHODS: An online and paper questionnaire was distributed to people with spinal cord injury, health care professionals and researchers working in spinal cord injury settings in the United Kingdom. RESULTS: A total of 299 participants completed the survey (152 people with spinal cord injury, 141 health care professionals and 6 researchers). Common views between groups identified were: (1) FES can be beneficial in improving physical and psychosocial aspects and that (2) adequate support and training for FES application was provided to users. Barriers to FES use included a lack of staff time and training, financial cost and availability of the equipment. Sixty three percent of non-users felt they would use FES in the future if they had the opportunity. CONCLUSIONS: Users' views were important in identifying that FES application can be beneficial for people with spinal cord injury but also has some resourceful barriers. In order to increase use, future research should focus on reducing the cost of FES clinical service and also address implementation of awareness and training programmes within spinal units and community rehabilitation settings.IMPLICATIONS FOR REHABILITATIONUsers of functional electrical stimulation think that it is beneficial for improving physical and psychosocial limitations after spinal cord injuryBarriers to FES use include a lack of staff time and training, financial cost and availability of the equipment have been suggested by people with spinal cord injury and health care professionalsEducation and implementation programs for health care professionals and people with spinal cord injury are now necessary to increase the awareness about functional electrical stimulation applicationReduction of FES cost could also increase its uptake in spinal cord injury clinical services.

The importance of self-efficacy and negative affect for neurofeedback success for central neuropathic pain after a spinal cord injury.

EEG-based neurofeedback uses mental behaviours (MB) to enable voluntary self-modulation of brain activity, and has potential to relieve central neuropathic pain (CNP) after a spinal cord injury (SCI). This study aimed to understand neurofeedback learning and the relationship between MB and neurofeedback success. Twenty-five non-CNP participants and ten CNP participants received neurofeedback training (reinforcing 9-12 Hz; suppressing 4-8 Hz and 20-30 Hz) on four visits. Participants were interviewed about the MB they used after each visit. Questionnaires examined the following factors: self-efficacy, locus of control, motivation, and workload of neurofeedback. MB were grouped into mental strategies (a goal-directed mental action) and affect (emotional experience during neurofeedback). Successful non-CNP participants significantly used more imagination-related MS and reported more negative affect compared to successful CNP participants. However, no mental strategy was clearly associated with neurofeedback success. There was some association between the lack of success and negative affect. Self-efficacy was moderately correlated with neurofeedback success (r = < 0.587, p = < 0.020), whereas locus of control, motivation, and workload had low, non-significant correlations (r < 0.300, p > 0.05). Affect may be more important than mental strategies for a successful neurofeedback performance. Self-efficacy was associated with neurofeedback success, suggesting that increasing confidence in one's neurofeedback abilities may improve neurofeedback performance.

The effects of FES cycling combined with virtual reality racing biofeedback on voluntary function after incomplete SCI: a pilot study.

BACKGROUND: Functional Electrical Stimulation (FES) cycling can benefit health and may lead to neuroplastic changes following incomplete spinal cord injury (SCI). Our theory is that greater neurological recovery occurs when electrical stimulation of peripheral nerves is combined with voluntary effort. In this pilot study, we investigated the effects of a one-month training programme using a novel device, the iCycle, in which voluntary effort is encouraged by virtual reality biofeedback during FES cycling. METHODS: Eleven participants (C1-T12) with incomplete SCI (5 sub-acute; 6 chronic) were recruited and completed 12-sessions of iCycle training. Function was assessed before and after training using the bilateral International Standards for Neurological Classification of SCI (ISNC-SCI) motor score, Oxford power grading, Modified Ashworth Score, Spinal Cord Independence Measure, the Walking Index for Spinal Cord Injury and 10 m-walk test. Power output (PO) was measured during all training sessions. RESULTS: Two of the 6 participants with chronic injuries, and 4 of the 5 participants with sub-acute injuries, showed improvements in ISNC-SCI motor score > 8 points. Median (IQR) improvements were 3.5 (6.8) points for participants with a chronic SCI, and 8.0 (6.0) points for those with sub-acute SCI. Improvements were unrelated to other measured variables (age, time since injury, baseline ISNC-SCI motor score, baseline voluntary PO, time spent training and stimulation amplitude; p > 0.05 for all variables). Five out of 11 participants showed moderate improvements in voluntary cycling PO, which did not correlate with changes in ISNC-SCI motor score. Improvement in PO during cycling was positively correlated with baseline voluntary PO (R2 = 0.50; p < 0.05), but was unrelated to all other variables (p > 0.05). The iCycle was not suitable for participants who were too weak to generate a detectable voluntary torque or whose effort resulted in a negative torque. CONCLUSIONS: Improved ISNC-SCI motor scores in chronic participants may be attributable to the iCycle training. In sub-acute participants, early spontaneous recovery and changes due to iCycle training could not be distinguished. The iCycle is an innovative progression from existing FES cycling systems, and positive results should be verified in an adequately powered controlled trial. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03834324. Registered 06 February 2019 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03834324. Protocol V03, dated 06.08.2015.

The application of precisely controlled functional electrical stimulation to the shoulder, elbow and wrist for upper limb stroke rehabilitation: a feasibility study.

BACKGROUND: Functional electrical stimulation (FES) during repetitive practice of everyday tasks can facilitate recovery of upper limb function following stroke. Reduction in impairment is strongly associated with how closely FES assists performance, with advanced iterative learning control (ILC) technology providing precise upper-limb assistance. The aim of this study is to investigate the feasibility of extending ILC technology to control FES of three muscle groups in the upper limb to facilitate functional motor recovery post-stroke. METHODS: Five stroke participants with established hemiplegia undertook eighteen intervention sessions, each of one hour duration. During each session FES was applied to the anterior deltoid, triceps, and wrist/finger extensors to assist performance of functional tasks with real-objects, including closing a drawer and pressing a light switch. Advanced model-based ILC controllers used kinematic data from previous attempts at each task to update the FES applied to each muscle on the subsequent trial. This produced stimulation profiles that facilitated accurate completion of each task while encouraging voluntary effort by the participant. Kinematic data were collected using a Microsoft Kinect, and mechanical arm support was provided by a SaeboMAS. Participants completed Fugl-Meyer and Action Research Arm Test clinical assessments pre- and post-intervention, as well as FES-unassisted tasks during each intervention session. RESULTS: Fugl-Meyer and Action Research Arm Test scores both significantly improved from pre- to post-intervention by 4.4 points. Improvements were also found in FES-unassisted performance, and the amount of arm support required to successfully perform the tasks was reduced. CONCLUSIONS: This feasibility study indicates that technology comprising low-cost hardware fused with advanced FES controllers accurately assists upper limb movement and may reduce upper limb impairments following stroke.

Electrical stimulation and iterative learning control for functional recovery in the upper limb post-stroke.

Therapies using functional electrical stimulation (FES) in conjunction with practice of everyday tasks have proven effective in facilitating recovery of upper limb function following stroke. The aim of the current study is to develop a multi-channel electrical stimulation system that precisely controls the assistance provided in goal-orientated tasks through use of advanced model-based 'iterative learning control' (ILC) algorithms to facilitate functional motor recovery of the upper limb post-stroke. FES was applied to three muscle groups in the upper limb (the anterior deltoid, triceps and wrist extensors) to assist hemiparetic, chronic stroke participants to perform a series of functional tasks with real objects, including closing a drawer, turning on a light switch and repositioning an object. Position data from the participants' impaired upper limb was collected using a Microsoft Kinect® and was compared to an ideal reference. ILC used data from previous attempts at the task to moderate the FES signals applied to each muscle group on a trial by trial basis to reduce performance error whilst supporting voluntary effort by the participant. The clinical trial is on-going. Preliminary results show improvements in performance accuracy for each muscle group, as well as improvements in clinical outcome measures pre and post 18 training sessions. Thus, the feasibility of applying precisely controlled FES to three muscle groups in the upper limb to facilitate functional reach and grasp movements post stroke has been demonstrated.

Functional electrical stimulation with exercises for standing balance and weight transfer in acute stroke patients: a feasibility randomized controlled trial.

OBJECTIVES: To test parameters needed for the design of a larger trial including the following: 1) identifying eligible participants, recruitment, and retention rates; 2) the feasibility and acceptability of delivering functional electrical stimulation (FES) to the gluteus maximus and quadriceps femoris for acute stroke patients in a hospital rehabilitation setting; 3) the outcome measures; 4) obtaining initial estimates of effect size; and 5) clarifying the relevant control group. MATERIALS AND METHODS: Twenty-one people with acute stroke-mean age = 68 (min to max: 33-87) years; weeks postonset = 4.6 (min to max: 1-14)-were randomized to three groups to receive two weeks of balance training with FES, balance training alone, or usual care. Symmetry in normal standing, weight transfer onto the affected limb, balance, mobility, and speed of walking were assessed before, shortly after the end of training, and two weeks later by a blinded assessor. RESULTS: 1) FES was successfully delivered but not with the planned eight sessions; 2) no trends in favor of FES were found; and 3) 4% of those screened took part but approaching 20% might be recruited in the future, no single outcome measure was suitable for all participants, and more routine physiotherapy was delivered to the control group. CONCLUSIONS: FES is feasible in this patient group but further feasibility and definitive trials are required.

A personalized sensor-controlled microstimulator system for arm rehabilitation poststroke. Part 1: System architecture.

OBJECTIVES: For rehabilitation of the poststroke upper limb in seven subjects, an external sensor-based system controls the timing of five to seven microstimulators implanted near radial nerve branches or their motor points to sequentially extend the elbow, wrist, and fingers with thumb extension and abduction, enabled at the subject's own pace. We hypothesize this system will support sequential activation of affected upper limb muscles intended to improve functional recovery. MATERIALS AND METHODS: Presented here is a personalized sensor-controlled stimulation system, including its architecture, sensor design, and testing of equipment specific to this study, including coils and sensors. RESULTS: All electrical and magnetic tests, and safety tests per International Electrotechnical Commission 60601-1 passed. One sensor type displayed a vulnerability to drop. CONCLUSIONS: The new control system tested safe, met requirements, and allowed each subject to activate the system at their own pace, making the rehabilitation process more acceptable and efficient.

A personalized sensor-controlled microstimulator system for arm rehabilitation poststroke. Part 2: Objective outcomes and patients' perspectives.

OBJECTIVE: To examine the effect of home-based electrical stimulation using closed-loop control of implanted microstimulators on upper limb function and impairment, and subjects' perception of the system. MATERIALS AND METHODS: Six subjects with poststroke hemiparesis, and reduced upper limb function, who had taken part in Phase 1 of the study, were fitted with a personalized closed-loop control system (Phase 2) and used it at home during performance of functional tasks for 12 weeks (Phase 3). Main outcome measures were: Action Research Arm Test (ARAT), Fugl-Meyer upper limb assessment (FMA), and motor control (Tracking Index). Subjects' perception of the system was assessed in a structured interview. RESULTS: Improvement in ARAT (p=0.05), FMA (p=0.02), and Tracking Index (p=0.03) during Phase 3. Five subjects said using the system had changed their lives and improved their function, all performed functional tasks with the system, but external components were inconvenient. CONCLUSIONS: Closed-loop control improved in function. Subjective assessment identified that the external sensors were effective.

The views of people with spinal cord injury about the use of functional electrical stimulation.

Functional electrical stimulation (FES) is a specialist technique that can be applied in several areas of spinal rehabilitation. The aim of the study was to explore views of people with spinal cord injuries (SCI), health care professionals specializing in SCI, and researchers in FES about the current and future use of FES. A qualitative design using eight focus groups lasting 90 to 120 min was carried out throughout the UK. Purposive sampling was used to ensure diversity in age, level of SCI, severity of injury, and experience using FES. Thematic analysis identified five key themes. Decisions to use FES related to concerns over the screening and suitability of FES, ensuring parity between patients, and offering FES at the right stage of rehabilitation. Positive aspects of using FES related to themes regarding "physical improvements" and "doing something active." Barriers to using FES concerned a lack of resources, such as equipment and staff training, and the view that some FES devices were unreliable. This research highlights the importance of understanding the user's needs in the design of FES devices; improving provision, prescription and allocation of FES resources, and the need to consider psychosocial issues related to the initiation and use of FES.

Stroke participants' perceptions of robotic and electrical stimulation therapy: a new approach.

PURPOSE: User perceptions are critical, yet often ignored factors in the design and development of rehabilitation technologies. In this article, measures for collection of patient perceptions are developed and applied to a novel upper limb workstation that combines robotic therapy and electrical stimulation (ES). METHOD: Five participants with chronic upper limb hemiplegia post-stroke used a robotic workstation to undertake supported tracking tasks augmented by precisely controlled ES to their triceps muscle. Following a 6 week trial, a purpose designed set of questions was developed and individual interviews were conducted by an independent health psychologist. RESULTS: The simple, quick to administer question set showed that participants had a positive response to the system, and contributed valuable feedback with regard to its usability and effectiveness. Participants want a home-based system targeting their whole arm. CONCLUSION: This article demonstrates the value in assessing user perceptions of a rehabilitation system via a simple question set. While the results of this study have implications for a wider audience, our recommendations are for a qualitative study to develop a generic evaluation tool which could be used across the growing number of devices to provide feedback to enhance future development of any new technology for rehabilitation.

Potential for new technologies in clinical practice.

PURPOSE OF REVIEW: Cost-effective neurorehabilitation is essential owing to financial constraints on healthcare resources. Technologies have the potential to contribute but without strong clinical evidence are unlikely to be widely reimbursed. This review presents evidence of new technologies since 2008 and identifies barriers to translation of technologies into clinical practice. RECENT FINDINGS: Technology has not been shown to be superior to intensively matched existing therapies. Research has been undertaken into the development and preliminary clinical testing of novel technologies including robotics, electrical stimulation, constraint-induced movement therapy, assistive orthoses, noninvasive brain stimulation, virtual reality and gaming devices. Translation of the research into clinical practice has been impeded by a lack of robust evidence of clinical effectiveness and usability. Underlying mechanisms associated with recovery are beginning to be explored, which may lead to more targeted interventions. Improvements in function have been demonstrated beyond the normal recovery period, but few trials demonstrate lasting effects. SUMMARY: Technologies, alone or combined, may offer a cost-effective way to deliver intensive neurorehabilitation therapy in clinical and community environments, and have the potential to empower patients to take more responsibility for their rehabilitation and continue with long-term exercise.

A model of the upper extremity using FES for stroke rehabilitation.

A model of the upper extremity is developed in which the forearm is constrained to lie in a horizontal plane and electrical stimulation is applied to the triceps muscle. Identification procedures are described to estimate the unknown parameters using tests that can be performed in a short period of time. Examples of identified parameters obtained experimentally are presented for both stroke patients and unimpaired subjects. A discussion concerning the identification's repeatability, together with results confirming the accuracy of the overall representation, is given. The model has been used during clinical trials in which electrical stimulation is applied to the triceps muscle of a number of stroke patients for the purpose of improving both their performance at reaching tasks and their level of voluntary control over their impaired arm. Its purpose in this context is threefold: Firstly, changes occurring in the levels of stiffness and spasticity in each subject's arm can be monitored by comparing frictional components of models identified at different times during treatment. Secondly, the model is used to calculate the moments applied during tracking tasks that are due to a patient's voluntary effort, and it therefore constitutes a useful tool with which to analyze their performance. Thirdly, the model is used to derive the advanced controllers that govern the level of stimulation applied to subjects over the course of the treatment. Details are provided to show how the model is applied in each case, and sample results are shown.

Therapeutic effectiveness of electric stimulation of the upper-limb poststroke using implanted microstimulators.

OBJECTIVE: To investigate the therapeutic effect of functional exercise augmented by programmable implanted microstimulators on arm and hand function. DESIGN: Before and after study. SETTING: Implantation was performed in a neurosurgery unit, systems were programmed, and tests were conducted in a university laboratory and subjects exercised at home. PARTICIPANTS: Hemiparetic subjects (N=7) with reduced upper-limb function who were at least 12 months poststroke were recruited from the community. No subjects withdrew. INTERVENTION: Microstimulators were implanted into the arms and forearms to activate elbow, wrist, and finger extension, and thumb abduction. After training and programming of the system, subjects underwent 12 weeks of functional home-based exercise with stimulation. MAIN OUTCOME MEASURES: The primary functional measure was the Action Research Arm Test (ARAT). Impairment measures included upper-limb Fugl-Meyer Assessment (FMA) and tests of motor control (tracking index), spasticity (electromyography stretch index) strength, and active range of motion (AROM). The assessor was not blinded, but scores were validated by an independent blinded observer. RESULTS: All subjects were able to perform functional activities at home by using the system. Compliance was excellent, and there were no serious adverse events. Statistically significant improvements were measured (P<.05) in the tracking index (57.3 degrees(2)+/-48.65 degrees(2)), FMA score (6.3+/-3.59), wrist-extensor strength (5.5+/-4.37 N), and wrist AROM (19.3 degrees +/-18.96 degrees). The mean improvement in ARAT score +/- SD of 4.9+/-7.89 was not statistically significant. CONCLUSIONS: This study has shown the feasibility of a programmable implanted microstimulator system used at home to perform functional exercises and a reduction in impairment after 12 weeks.

Poststroke upper-limb rehabilitation using 5 to 7 inserted microstimulators: implant procedure, safety, and efficacy for restoration of function.

OBJECTIVE: To investigate the feasibility of implanting microstimulators to deliver programmed nerve stimulation for sequenced muscle activation to recover arm-hand functions. DESIGN: By using a minimally invasive procedure and local anesthesia, 5 to 7 microstimulators can be safely and comfortably implanted adjacent to targeted radial nerve branches in the arm and forearm of 7 subjects with poststroke paresis. The microstimulators' position should remain stable with no tissue infection and can be programmed to produce effective personalized functional muscle activity with no discomfort for a preliminary 12-week study. Clinical testing, before and after the study, is reported in the accompanying study. SETTING: Microstimulator implantations in a sterile operating room. PARTICIPANTS: Seven adults, with poststroke hemiparesis of 12 months or more. INTERVENTION: Under local anesthesia, a stimulating probe was inserted to identify radial nerve branches. Microstimulators were inserted by using an introducer and were retrievable for 6 days by attached suture. Each device was powered via a radiofrequency link from 2 external cuff coils connected to a control unit. MAIN OUTCOME MEASURES: To achieve low threshold values at the target sites with minimal implant discomfort. Microstimulators and external equipment were monitored over 12 weeks of exercise. RESULTS: Seven subjects were implanted with 41 microstimulators, 5 to 7 per subject, taking 3.5 to 6 hours. Implantation pain levels were 20% more than anticipated. No infections or microstimulator failures occurred. Mean nerve thresholds ranged between 4.0 to 7.7 microcoulomb/cm(2)/phase over 90 days, indicating that cathodes were within 2 to 4 mm of target sites. In 1 subject, 2 additional microstimulators were inserted. CONCLUSIONS: Microstimulators were safely implanted with no infection or failure. The system was reliable and programmed effectively to perform exercises at home for functional restoration.

Patients' perceptions of the benefits and problems of using the ActiGait implanted drop-foot stimulator.

OBJECTIVE: To evaluate patients' perceptions of the benefits and problems associated with using the ActiGait implanted drop-foot stimulator. METHOD: Thirteen participants who had suffered a stroke at least 6 months prior to recruitment, had a drop-foot that affected walking and had taken part in a trial in which an ActiGait drop-foot stimulator had been implanted, completed a postal questionnaire. RESULTS: Users agreed that the ActiGait had a positive effect on walking; they used it regularly and had little difficulty with putting it on and taking it off. Reliability was a greater problem at 90 days than at the final assessment. Ten of the 13 responders either agreed or strongly agreed with the statement that the ActiGait improved their quality of life at 90 days and 9 out of 12 at the final assessment: 11 of the 12 respondents would recommend the ActiGait to others. DISCUSSION AND CONCLUSION: From the users' perspective the ActiGait improved walking, it was reported to be used regularly and it appeared to be easier to use than a surface system. Users were equivocal about the reliability of the system at 90 days, but at the final assessment reliability had improved.

Phase II trial to evaluate the ActiGait implanted drop-foot stimulator in established hemiplegia.

OBJECTIVE: To evaluate a selective implantable drop foot stimulator (ActiGait) in terms of effect on walking and safety. DESIGN: A phase II trial in which a consecutive sample of participants acted as their own controls. SUBJECTS: People who had suffered a stroke at least 6 months prior to recruitment and had a drop-foot that affected walking were recruited from 3 rehabilitation centres in Denmark. METHODS: Stimulators were implanted into all participants. Outcome measures were range of ankle dorsiflexion with stimulation and maximum walking speed and distance walked in 4 minutes. Measurements were applied before implantation, at 90 days and at a long-term follow-up assessment. Changes over time and with and without stimulation are reported. Safety was evaluated by nerve conduction velocity and adverse events. RESULTS: Fifteen participants were implanted and 13 completed the trial. Long-term improvements were detected in walking speed and distance walked in 4 minutes when stimulated, and the orthotic effect of stimulation showed statistically significant improvement. The device did not compromise nerve conduction velocity and no serious device-related adverse events were reported. Technical problems were resolved by the long-term follow-up assessment at which further improvement in walking was observed. CONCLUSION: This trial has evaluated the safety and performance of the device, which was well accepted by patients and did not compromise safety.

The effect of combined use of botulinum toxin type A and functional electric stimulation in the treatment of spastic drop foot after stroke: a preliminary investigation.

OBJECTIVE: To investigate the effect of combined botulinum toxin type A (BTX) and functional electric stimulation (FES) treatment on spastic drop foot in stroke. DESIGN: Nonblinded randomized controlled trial. SETTING: Hospitals. PARTICIPANTS: Consecutive sample of 21 ambulant adults within 1 year after stroke with a spastic drop foot, of whom 18 completed the study. INTERVENTIONS: The treatment group received BTX injections (Dysport) on 1 occasion into the medial and lateral heads of the gastrocnemius (200U each) and tibialis posterior (400U each) muscles and FES, used on a daily basis for 16 weeks to assist walking. Both groups continued with physiotherapy at the same rate. MAIN OUTCOME MEASURES: Walking speed, Physiological Cost Index, Modified Ashworth Scale, Rivermead Motor Assessment, and Medical Outcomes Study 36-Item Short-Form Health Survey. RESULTS: Walking speed increased over 12 weeks in both control (P=.020) and treatment groups (nonstimulated, P=.004; stimulated, P=.042). The baseline corrected (analysis of covariance) increase in mean walking speed at 12 weeks, relative to controls, was.04m/s (95% confidence interval [CI],.003-.090) without stimulation, and.09m/s (95% CI,.031-.150) with stimulation. CONCLUSIONS: Combined treatment effectively improved walking and function. A larger study is needed to quantify the treatment effect and to investigate its impact on quality of life.

A pilot study to investigate the combined use of botulinum neurotoxin type a and functional electrical stimulation, with physiotherapy, in the treatment of spastic dropped foot in subacute stroke.

The objective was to inform sample size calculations for a full randomized controlled trial (RCT). The design included an RCT pilot trial with a 16 week study period, including a 4 week baseline phase. The subjects were adults within 1 year of first stroke, ambulant with a spastic dropped foot. Twenty-one participants were recruited from the stroke services of 4 centers. For intervention all participants received physiotherapy; the treatment group also received botulinum neurotoxin Type A (BoNTA) intramuscular injections to triceps surae (800 U Dysport) and functional electrical stimulation (FES) of the common peroneal nerve to assist walking. The main outcome measure was walking speed. The result was a significant upward trend in median walking speed for both the control (p = 0.02) and treatment groups (nonstimulated p = 0.004, stimulated p = 0.042). Trend lines were different in location (p = 0.04 and p = 0.009, respectively). In conclusion, there is evidence of an additional, beneficial effect of BoNTA and FES. Sufficient information has been gained on the variability of the primary outcome measure to inform sample size calculations for a full RCT to quantify the treatment effect with precision.