Nerve transfer for restoration of lower motor neuron-lesioned bladder, urethral and anal sphincter function. Part 4: Effectiveness of the motor reinnervation.

In pilot work, we showed that somatic nerve transfers can restore motor function in long-term decentralized dogs. We continue to explore the effectiveness of motor reinnervation in 30 female dogs. After anesthesia, 12 underwent bilateral transection of coccygeal and sacral (S) spinal roots, dorsal roots of lumbar (L)7, and hypogastric nerves. Twelve months postdecentralization, eight underwent transfer of obturator nerve branches to pelvic nerve vesical branches, and sciatic nerve branches to pudendal nerves, followed by 10 mo recovery (ObNT-ScNT Reinn). The remaining four were euthanized 18 mo postdecentralization (Decentralized). Results were compared with 18 Controls. Squat-and-void postures were tracked during awake cystometry. None showed squat-and-void postures during the decentralization phase. Seven of eight ObNT-ScNT Reinn began showing such postures by 6 mo postreinnervation; one showed a return of defecation postures. Retrograde dyes were injected into the bladder and urethra 3 wk before euthanasia, at which point, roots and transferred nerves were electrically stimulated to evaluate motor function. Upon L2-L6 root stimulation, five of eight ObNT-ScNT Reinn showed elevated detrusor pressure and four showed elevated urethral pressure, compared with L7-S3 root stimulation. After stimulation of sciatic-to-pudendal transferred nerves, three of eight ObNT-ScNT Reinn showed elevated urethral pressure; all showed elevated anal sphincter pressure. Retrogradely labeled neurons were observed in L2-L6 ventral horns (in laminae VI, VIII, and IX) of ObNT-ScNT Reinn versus Controls in which labeled neurons were observed in L7-S3 ventral horns (in lamina VII). This data supports the use of nerve transfer techniques for the restoration of bladder function.NEW & NOTEWORTHY This data supports the use of nerve transfer techniques for the restoration of bladder function.

Conserved and species-specific transcriptional responses to daily programmed resistance exercise in rat and mouse.

Mice are often used in gain or loss of function studies to understand how genes regulate metabolism and adaptation to exercise in skeletal muscle. Once-daily resistance training with electrical nerve stimulation produces hypertrophy of the dorsiflexors in rat, but not in mouse. Using implantable pulse generators, we assessed the acute transcriptional response (1-h post-exercise) after 2, 10, and 20 days of training in free-living mice and rats using identical nerve stimulation paradigms. RNA sequencing revealed strong concordance in the timecourse of many transcriptional responses in the tibialis anterior muscles of both species including responses related to "stress responses/immediate-early genes, and "collagen homeostasis," "ribosomal subunits," "autophagy," and "focal adhesion." However, pathways associated with energy metabolism including "carbon metabolism," "oxidative phosphorylation," "mitochondrial translation," "propanoate metabolism," and "valine, leucine, and isoleucine degradation" were oppositely regulated between species. These pathways were suppressed in the rat but upregulated in the mouse. Our transcriptional analysis suggests that although many pathways associated with growth show remarkable similarities between species, the absence of an actual growth response in the mouse may be because the mouse prioritizes energy metabolism, specifically the replenishment of fuel stores and intermediate metabolites.

A single-center, assessor-blinded, randomized controlled clinical trial to test the safety and efficacy of a novel brain-computer interface controlled functional electrical stimulation (BCI-FES) intervention for gait rehabilitation in the chronic stroke population.

BACKGROUND: In the United States, there are over seven million stroke survivors, with many facing gait impairments due to foot drop. This restricts their community ambulation and hinders functional independence, leading to several long-term health complications. Despite the best available physical therapy, gait function is incompletely recovered, and this occurs mainly during the acute phase post-stroke. Therapeutic options are limited currently. Novel therapies based on neurobiological principles have the potential to lead to long-term functional improvements. The Brain-Computer Interface (BCI) controlled Functional Electrical Stimulation (FES) system is one such strategy. It is based on Hebbian principles and has shown promise in early feasibility studies. The current study describes the BCI-FES clinical trial, which examines the safety and efficacy of this system, compared to conventional physical therapy (PT), to improve gait velocity for those with chronic gait impairment post-stroke. The trial also aims to find other secondary factors that may impact or accompany these improvements and establish the potential of Hebbian-based rehabilitation therapies. METHODS: This Phase II clinical trial is a two-arm, randomized, controlled, longitudinal study with 66 stroke participants in the chronic (> 6 months) stage of gait impairment. The participants undergo either BCI-FES paired with PT or dose-matched PT sessions (three times weekly for four weeks). The primary outcome is gait velocity (10-meter walk test), and secondary outcomes include gait endurance, range of motion, strength, sensation, quality of life, and neurophysiological biomarkers. These measures are acquired longitudinally. DISCUSSION: BCI-FES holds promise for gait velocity improvements in stroke patients. This clinical trial will evaluate the safety and efficacy of BCI-FES therapy when compared to dose-matched conventional therapy. The success of this trial will inform the potential utility of a Phase III efficacy trial. TRIAL REGISTRATION: The trial was registered as "BCI-FES Therapy for Stroke Rehabilitation" on February 19, 2020, at clinicaltrials.gov with the identifier NCT04279067.

A novel functional electrical stimulation sleeve based on textile-embedded dry electrodes.

BACKGROUND: Functional electrical stimulation (FES) is a rehabilitation technique that enables functional improvements in patients with motor control impairments. This study presents an original design and prototyping method for a smart sleeve for FES applications. The article explains how to integrate a carbon-based dry electrode into a textile structure and ensure an electrical connection between the electrodes and the stimulator for effective delivery of the FES. It also describes the materials and the step-by-step manufacturing processes. RESULTS: The carbon-based dry electrode is integrated into the textile substrate by a thermal compression molding process on an embroidered conductive matrix. This matrix is composed of textile silver-plated conductive yarns and is linked to the stimulator. Besides ensuring the electrical connection, the matrix improves the fixation between the textile substrate and the electrode. The stimulation intensity, the perceived comfort and the muscle torque generated by the smart FES sleeve were compared to hydrogel electrodes. The results show a better average comfort and a higher average stimulation intensity with the smart FES sleeve, while there were no significant differences for the muscle torque generated. CONCLUSIONS: The integration of the proposed dry electrodes into a textile is a viable solution. The wearable FES system does not negatively impact the electrodes' performance, and tends to improve it. Additionally, the proposed prototyping method is applicable to an entire garment in order to target all muscles. Moreover, the process is feasible for industrial production and commercialization since all materials and processes used are already available on the market.

A dry polymer nanocomposite transcutaneous electrode for functional electrical stimulation.

BACKGROUND: Functional electrical stimulation (FES) can be used in rehabilitation to aid or improve function in people with paralysis. In clinical settings, it is common practice to use transcutaneous electrodes to apply the electrical stimulation, since they are non-invasive, and can be easily applied and repositioned as necessary. However, the current electrode options available for transcutaneous FES are limited and can have practical disadvantages, such as the need for a wet interface with the skin for better comfort and performance. Hence, we were motivated to develop a dry stimulation electrode which could perform equivalently or better than existing commercially available options. METHODS: We manufactured a thin-film dry polymer nanocomposite electrode, characterized it, and tested its performance for stimulation purposes with thirteen healthy individuals. We compared its functionality in terms of stimulation-induced muscle torque and comfort level against two other types of transcutaneous electrodes: self-adhesive hydrogel and carbon rubber. Each electrode type was also tested using three different stimulators and different intensity levels of stimulation. RESULTS: We found the proposed dry polymer nanocomposite electrode to be functional for stimulation, as there was no statistically significant difference between its performance to the other standard electrodes. Namely, the proposed dry electrode had comparable muscle torque generated and comfort level as the self-adhesive hydrogel and carbon rubber electrodes. From all combinations of electrode type and stimulators tested, the dry polymer nanocomposite electrode with the MyndSearch stimulator had the most comfortable average rating. CONCLUSIONS: The dry polymer nanocomposite electrode is a durable and flexible alternative to existing self-adhesive hydrogel and carbon rubber electrodes, which can be used without the addition of a wet interfacing agent (i.e., water or gel) to perform as well as the current electrodes used for stimulation purposes.

Feasibility of using a depth camera or pressure mat for visual feedback balance training with functional electrical stimulation.

Individuals with incomplete spinal-cord injury/disease are at an increased risk of falling due to their impaired ability to maintain balance. Our research group has developed a closed-loop visual-feedback balance training (VFBT) system coupled with functional electrical stimulation (FES) for rehabilitation of standing balance (FES + VFBT system); however, clinical usage of this system is limited by the use of force plates, which are expensive and not easily accessible. This study aimed to investigate the feasibility of a more affordable and accessible sensor such as a depth camera or pressure mat in place of the force plate. Ten able-bodied participants (7 males, 3 females) performed three sets of four different standing balance exercises using the FES + VFBT system with the force plate. A depth camera and pressure mat collected centre of mass and centre of pressure data passively, respectively. The depth camera showed higher Pearson's correlation (r > 98) and lower root mean squared error (RMSE < 10 mm) than the pressure mat (r > 0.82; RMSE < 4.5 mm) when compared with the force plate overall. Stimulation based on the depth camera showed lower RMSE than that based on the pressure mat relative to the FES + VFBT system. The depth camera shows potential as a replacement sensor to the force plate for providing feedback to the FES + VFBT system.

Contralaterally Controlled Functional Electrical Stimulation for Improving Motor Function After Acquired Brain Injury: A Systematic Review and Meta-analysis.

OBJECTIVE: To systematically evaluate the effect of contralaterally controlled functional electrical stimulation (CCFES) on motor function after acquired brain injury (ABI). DATA SOURCES: We searched the PubMed, Embase, Cochrane Central Register of Controlled Trials, Physiotherapy Evidence Database (PEDro), Web of Science, SinoMed, CNKI, VIP Database for Chinese Technical Periodicals and Wanfang Database, from inception to December 2023. STUDY SELECTION: Studies were included if they were randomized controlled trials assessing the effect of CCFES on motor function compared with routine rehabilitation or routine electrical stimulation after ABI. Two independent reviewers screened 894 articles for inclusion. DATA EXTRACTION: The extracted data included study information, sample size, study population, interventions, measurement evaluated, and the test interval. DATA SYNTHESIS: This study included 24 trials with 28 intervention-control pairs and 1148 participants with stroke. Meta-analysis showed that the CCFES group demonstrated more significant improvement than the control group in the Fugl-Meyer Assessment Scale (FMA) (standardized mean difference [SMD]=0.66, 95% confidence interval [CI]=0.44-0.88, P<.001), active range of motion (AROM) (SMD=0.77, 95% CI=0.54-1.01, P<.001), modified Barthel Index (MBI) (SMD=0.55, 95% CI=0.29-0.81, P<.001), Motricity Index (MI) (SMD=0.60, 95% CI=0.26-0.94, P<.001) surface electromyography (sEMG) (SMD=0.81, 95% CI=0.56-1.06, P<.001), and Functional Ambulation Category (FAC) (SMD=0.53, 95% CI=0.24-0.83, P<.001). The CCFES group showed no significant improvement over the control group in the Action Research Arm Test (ARAT) (SMD=0.24, 95% CI=-0.10-0.58, P=.17). CONCLUSIONS: Our synthesized evidence suggests that CCFES could improve motor function in patients with stroke. More RCTs with other patients with brain injury are required to provide future evidence on the therapy effect of CCFES and make a contribution to the uniform standard of CCFES.

The International Functional Electrical Stimulation Society (IFESS): Highlights from the IFESS conference at Rehabweek 2023.

The annual conference of the International Functional Electrical Stimulation Society (IFESS) was held in conjunction with the 7th RehabWeek Congress, from September 24 to 28, 2023 at the Resorts World Convention Centre on Sentosa Island, in Singapore. The Congress was a joint meeting of the International Consortium on Rehabilitation Technology (ICRT) together with 10 other societies in the field of assistive technology and rehabilitation engineering. The conference features comprehensive blend of technical and clinical context of FES, a sustained value the society has offered over many years. The cross- and inter- disciplinary approach of medicine, engineering, and science practiced in the FES community had enabled vibrant interaction, creation, and development of impactful and novel contributions to the field of FES, translating FES directly into highly relevant and sustainable solutions for the users.

Physical and occupational therapists' learning needs and preferences for education on functional electrical stimulation: A qualitative descriptive study.

BACKGROUND: Functional electrical stimulation (FES) is an evidence-based intervention that is rarely used by Canadian physical therapists (PTs) and occupational therapists (OTs). A common barrier to FES implementation is a lack of knowledge and training. FES learning resources that meet therapists' learning needs and preferences may address this barrier. OBJECTIVE: To explore OTs' and PTs' perspectives on the utility of FES e-learning resources, including whether the resources met their learning needs and preferences. METHODS: Through this qualitative descriptive study, feedback on FES e-learning resources was solicited from 5 PTs and 18 OTs who work clinically, but do not use FES. Participants reviewed ≥3 prerecorded lectures on FES topics and then completed a semi-structured interview. Participants were asked about the lectures' content, delivery, ease of use and comprehensibility, and were asked to suggest modifications to facilitate self-directed learning about FES. Interviews were analyzed using conventional content analysis. RESULTS: Three themes were identified. (1) Feedback on FES e-learning: the content and delivery of the prerecorded lectures facilitated participants' learning, although opportunities to improve content and delivery were identified. (2) Factors influencing FES learning needs and preferences: Participants identified internal (i.e., baseline knowledge, learning style) and external (i.e., learning with colleagues, practice setting) factors that affected learning. Themes 1 and 2 impacted (3) the effects of FES e-learning: Participants described the outcomes of their FES e-learning, including increases in FES knowledge, confidence, and use in clinical practice. CONCLUSION: Therapists' perceived the FES e-learning resources to be useful and to address their learning needs and preferences.

High-intensity interval training with functional electrical stimulation cycling for incomplete spinal cord injury patients: A pilot feasibility study.

BACKGROUND: Consequences of spinal cord injury (SCI) with a sedentary lifestyle will progress to muscle weakness and muscle atrophy, leading to muscle fatigue. This study aimed to determine the feasibility and preliminary effects of high-intensity interval training (HIIT) using functional electrical stimulation (FES) cycling on changes in thigh muscle volume and muscle strength, in patients with incomplete SCI. METHODS: Eight incomplete SCI patients (mean age 50 years; 6 women) with stable SCI paraplegia (mean 6.75 years since injury) participated in the HIIT FES cycling (85%-90% peak Watts; 4 × 4-min intervals) three times a week (over 6 weeks). The main outcomes were adherence, participant acceptability, and adverse events. Secondary outcomes were muscle strength (peak torque) and leg volume changes. RESULTS: Our findings revealed that the program was well-received by participants, with high levels of adherence, positive feedback, and satisfaction, suggesting that it could be a promising option for individuals seeking to enhance their lower body strength and muscle mass. Additionally, all participants successfully completed the training without any serious adverse events, indicating that the program is safe for use. Finally, we found that the 6-week HIIT FES leg cycling exercise program resulted in notable improvements in isometric peak torque of the quadriceps (range 13.9%-25.6%), hamstring muscle (18.2%-23.3%), and leg volume (1.7%-18.2%). CONCLUSIONS: This study highlights HIIT FES leg cycling exercise program potential as an effective intervention for improving lower limb muscle function.

Ink-based textile electrodes for wearable functional electrical stimulation: A proof-of-concept study to evaluate comfort and efficacy.

BACKGROUND: Functional Electrical Stimulation (FES) represents a promising technique for promoting functional recovery in individuals with neuromuscular diseases. Traditionally, current pulses are delivered through self-adhesive hydrogel Ag/AgCl electrodes, which allow a good contact with the skin, are easy-to-use and have a moderate cost. However, skin adherence decreases after a few uses and skin irritations can originate. Recently, textile electrodes have become an attractive alternative as they assure increased durability, easy integration into clothes and can be conveniently cleaned, improving the wearability of FES. However, as various manufacture processes were attempted, their clear validation is lacking. This proof-of-concept study proposes a novel set of ink-based printed textile electrodes and compares them to adhesive hydrogel electrodes in terms of impedance, stimulation performance and perceived comfort. METHODS: The skin-electrode impedance was evaluated for both types of electrodes under different conditions. These electrodes were then used to deliver FES to the Rectus Femoris of 14 healthy subjects to induce its contraction in both isometric and dynamic conditions. This allowed to compare the two types of electrodes in terms of sensory, motor, maximum and pain thresholds, FES-induced range of motion during dynamic tests, FES-induced torque during isometric tests and perceived stimulation comfort. RESULTS: No statistically significant differences were found both in terms of stimulation performance (Wilcoxon test) and comfort (Generalized Linear Mixed Model). CONCLUSION: The results showed that the proposed ink-based printed textile electrodes can be effectively used as alternative to hydrogel ones. Further experiments are needed to evaluate their durability and their response to sterilizability and stretching tests.

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 new modular neuroprosthesis suitable for hybrid FES-robot applications and tailored assistance.

BACKGROUND: To overcome the application limitations of functional electrical stimulation (FES), such as fatigue or nonlinear muscle response, the combination of neuroprosthetic systems with robotic devices has been evaluated, resulting in hybrid systems that have promising potential. However, current technology shows a lack of flexibility to adapt to the needs of any application, context or individual. The main objective of this study is the development of a new modular neuroprosthetic system suitable for hybrid FES-robot applications to meet these needs. METHODS: In this study, we conducted an analysis of the requirements for developing hybrid FES-robot systems and reviewed existing literature on similar systems. Building upon these insights, we developed a novel modular neuroprosthetic system tailored for hybrid applications. The system was specifically adapted for gait assistance, and a technological personalization process based on clinical criteria was devised. This process was used to generate different system configurations adjusted to four individuals with spinal cord injury or stroke. The effect of each system configuration on gait kinematic metrics was analyzed by using repeated measures ANOVA or Friedman's test. RESULTS: A modular NP system has been developed that is distinguished by its flexibility, scalability and personalization capabilities. With excellent connection characteristics, it can be effectively integrated with robotic devices. Its 3D design facilitates fitting both as a stand-alone system and in combination with other robotic devices. In addition, it meets rigorous requirements for safe use by incorporating appropriate safety protocols, and features appropriate battery autonomy, weight and dimensions. Different technological configurations adapted to the needs of each patient were obtained, which demonstrated an impact on the kinematic gait pattern comparable to that of other devices reported in the literature. CONCLUSIONS: The system met the identified technical requirements, showcasing advancements compared to systems reported in the literature. In addition, it demonstrated its versatility and capacity to be combined with robotic devices forming hybrids, adapting well to the gait application. Moreover, the personalization procedure proved to be useful in obtaining various system configurations tailored to the diverse needs of individuals.

Investigation of Motor Learning Effects Using a Hybrid Rehabilitation System Based on Motion Estimation.

Upper-limb paralysis requires extensive rehabilitation to recover functionality for everyday living, and such assistance can be supported with robot technology. Against such a background, we have proposed an electromyography (EMG)-driven hybrid rehabilitation system based on motion estimation using a probabilistic neural network. The system controls a robot and functional electrical stimulation (FES) from movement estimation using EMG signals based on the user's intention, enabling intuitive learning of joint motion and muscle contraction capacity even for multiple motions. In this study, hybrid and visual-feedback training were conducted with pointing movements involving the non-dominant wrist, and the motor learning effect was examined via quantitative evaluation of accuracy, stability, and smoothness. The results show that hybrid instruction was as effective as visual feedback training in all aspects. Accordingly, passive hybrid instruction using the proposed system can be considered effective in promoting motor learning and rehabilitation for paralysis with inability to perform voluntary movements.

Recognition of Human Lower Limb Motion and Muscle Fatigue Status Using a Wearable FES-sEMG System.

Functional electrical stimulation (FES) devices are widely employed for clinical treatment, rehabilitation, and sports training. However, existing FES devices are inadequate in terms of wearability and cannot recognize a user's intention to move or muscle fatigue. These issues impede the user's ability to incorporate FES devices into their daily life. In response to these issues, this paper introduces a novel wearable FES system based on customized textile electrodes. The system is driven by surface electromyography (sEMG) movement intention. A parallel structured deep learning model based on a wearable FES device is used, which enables the identification of both the type of motion and muscle fatigue status without being affected by electrical stimulation. Five subjects took part in an experiment to test the proposed system, and the results showed that our method achieved a high level of accuracy for lower limb motion recognition and muscle fatigue status detection. The preliminary results presented here prove the effectiveness of the novel wearable FES system in terms of recognizing lower limb motions and muscle fatigue status.

Effectiveness of functional electrical stimulation machine in managing neurological diseases - A retrospective study.

Background & Objective: Cerebrovascular Accident (CVA) or stroke, Spinal Cord injury can lead to neurological diseases resulting in major loss in motor function causing hemiplegia or tetraplegia. In 2019, according to The Global Burden of Diseases (GBD) CVA/Stroke is the second leading cause of death and the third leading cause of death and disability combined, globally. Its prevalence vary drastically among South Asian countries. The objective of this study was to determine the effectiveness of Functional Electrical Stimulation (FES) machine on neurologically impaired patients at the Physical Therapy department at IHHN, Karachi, Pakistan. Method: In this retrospective study data was extracted from August 2016 to February 2022 on patients with neurological symptoms i.e. hemiplegia or paraplegia with muscle power of two or less on Manual Muscle Testing (MMT). The parameters for evaluating patients progress pre and post treatment were MMT results and their mobility status. The number of sessions ranged between 40 to 100 sessions of Functional Electrical Stimulation (FES) provided on alternate days according to the patient's need. Result: Data of 51 patients who had completed their treatment were extracted and analyzed. The mean age of patients who completed treatment was 49.62 ± 17.26 years. Out of 51(100%), 30 (58.8%) were male and 21 (41.2%) were female. Pre- and post-treatment median (IQR) showed remarkable improvement in MMT of upper limb muscle (from 1.0 to 4.0) and lower limb muscle (from 2.0 to 4.0). Conclusion: FES cycling is an effective treatment for patients with neurological impairments, as it resulted in improvement in both upper and lower limb muscle strength, along with mobility status.

[A review of functional electrical stimulation based on brain-computer interface].

Individuals with motor dysfunction caused by damage to the central nervous system are unable to transmit voluntary movement commands to their muscles, resulting in a reduced ability to control their limbs. However, traditional rehabilitation methods have problems such as long treatment cycles and high labor costs. Functional electrical stimulation (FES) based on brain-computer interface (BCI) connects the patient's intentions with muscle contraction, and helps to promote the reconstruction of nerve function by recognizing nerve signals and stimulating the moving muscle group with electrical impulses to produce muscle convulsions or limb movements. It is an effective treatment for sequelae of neurological diseases such as stroke and spinal cord injury. This article reviewed the current research status of BCI-based FES from three aspects: BCI paradigms, FES parameters and rehabilitation efficacy, and looked forward to the future development trend of this technology, in order to improve the understanding of BCI-based FES.

Synergy-based functional electrical stimulation and robotic-assisted for retraining reach-to-grasp in stroke: a study protocol for a randomized controlled trial.

BACKGROUND: Stroke survivors have long-term upper limb impairment, which impacts the quality of life (QOL) and social reintegration, but there is lack of effective therapeutic strategies and novel technologies. Customized multi-muscle functional electrical stimulation (FES) based on the muscle synergy of healthy adults and robotic-assisted therapy (RAT) have been proved efficacy respectively. Synergy-based FES combined with RAT can be a novel and more effective therapy for upper limb recovery of stroke survivors from the perspective of synergistic enhancement. However, few studies have examined the effectiveness of combined synergy-based FES and RAT, especially for motor control evaluated by reach-to-grasp (RTG) movements. The main objective of the following research protocol is to evaluate the effectiveness and efficacy, as well as adoptability, of FES-RAT and FES or RAT rehabilitation program for upper limb function improvement after stroke. METHODS: This will be an assessor-blinded randomized controlled trial involving a 12-week intervention and a 6-month follow-up. Stratified randomization will be used to equally and randomly assign 162 stroke patients into the FES + conventional rehabilitation program (CRP) group, RAT + CRP group and FES-RAT + CRP group. Interventions will be provided in 5 sessions per week, with a total of 60 sessions. The primary outcome measurements will include the Fugl-Meyer Assessment and Biomechanical Assessment of RTG movements. The secondary outcome measurements will include quality of life and brain neuroplasticity assessments by MRI. Evaluations will be performed at five time points, including at baseline, 6 weeks and 12 weeks from the start of treatment, and 3 months and 6 months following the end of treatment. A two-way analysis of variance with repeated measures will be applied to examine the main effects of the group, the time factor and group-time interaction effects. DISCUSSION: The results of the study protocol will provide high quality evidence for integrated synergy-based FES and RAT, and synergy-based FES alone and guide the design of more effective treatment methods for stroke rehabilitation. TRIAL REGISTRATION: ChiCTR2300071588.

Identifying priorities for balance interventions through a participatory co-design approach with end-users.

BACKGROUND: Most individuals living with spinal cord injuries/diseases (SCI/D) or stroke experience at least one fall each year; hence, the development of interventions and technologies that target balance control is needed. The purpose of this study was to identify and explore the priorities for balance-focused interventions and technologies from the perspectives of end-users to assist with the design of an intervention that combines functional electrical stimulation (FES) with visual feedback training for standing balance. METHODS: Two individuals with SCI/D, one individual with stroke, two physical therapists (PT) and one hospital administrator were recruited. Participants attended three focus group meetings that followed a participatory co-design approach. A semi-structured interview guide, developed from the FAME (Feasibility, Appropriateness, Meaningfulness, Effectiveness, Economic Evidence) framework, was used to lead the discussion, querying participants' experiences with balance deficits and interventions, and FES. Meetings were audio-recorded and transcribed verbatim. An iterative and reflexive inductive thematic analysis was applied to the transcripts by three researchers. RESULTS: Four themes were identified: (1) Balance is meaningful for daily life and rehabilitation. Participants acknowledged various factors influencing balance control and how balance deficits interfered with participation in activities. End-users stressed the importance of continuing to work on one's balance after discharge from hospital-based rehabilitation. (2) Desired characteristics of balance interventions. Participants explained that balance interventions should be tailored to an individual's unique needs and goals, relevant to their lives, balance their safety and risk, and be engaging. (3) Prior experiences with FES to inform future therapeutic use. Participants with stroke or SCI/D described initial apprehension with FES, but experienced numerous benefits that motivated them to continue with FES. Challenges with FES were mentioned, including wires, cost, and time of set up. (4) Potential role of FES in balance interventions. Participants felt that FES would complement balance interventions; however, they had not experienced this combination of therapies previously. CONCLUSIONS: End-users described how their experiences with balance deficits, rehabilitation, and FES informed their priorities for balance interventions. The findings inform the design and implementation of future balance interventions for individuals with SCI/D or stroke, including an intervention involving FES and visual feedback training.

Efficacy of functional electrical stimulation in rehabilitating patients with foot drop symptoms after stroke and its correlation with somatosensory evoked potentials-a crossover randomised controlled trial.

OBJECTIVE: The connectivity between somatosensory evoked potentials (SEPs) and cortical plasticity remains elusive due to a lack of supporting data. This study investigates changes in pathological latencies and amplitudes of SEPs caused by an acute stroke after 2 weeks of rehabilitation with functional electrical stimulation (FES). Furthermore, changes in SEPs and the efficacy of FES against foot drop (FD) stroke symptoms were correlated using the 10-m walk test and foot-ankle strength. METHODS: A randomised controlled two-period crossover design plus a control group (group C) was designed. Group A (n = 16) was directly treated with FES, while group B (n = 16) was treated after 2 weeks. The untreated control group of 20 healthy adults underwent repeated SEP measurements for evaluation only. RESULTS: The repeated-measures ANOVA showed a decrease in tibial nerve (TN) P40 and N50 latencies in group A after the intervention, followed by a decline in non-paretic TN SEP in latency N50 (p < 0.05). Moreover, compared to groups B and C from baseline to 4 weeks, group A showed a decrease in paretic TN latency P40 and N50 (p < 0.05). An increase in FD strength and a reduction in step cadence in group B (p < 0.05) and a positive tendency in FD strength (p = 0.12) and step cadence (p = 0.08) in group A were observed after the treatment time. The data showed a moderate (r = 0.50-0.70) correlation between non-paretic TN latency N50 and step cadence in groups A and B after the intervention time. CONCLUSION: The FES intervention modified the pathological gait in association with improved SEP afferent feedback. Registered on 25 February 2021 on ClinicalTrials.gov under identifier number: NCT04767360.