Rehabilitation Assessment System for Stroke Patients Based on Fusion-Type Optoelectronic Plethysmography Device and Multi-Modality Fusion Model: Design and Validation.

This study aimed to propose a portable and intelligent rehabilitation evaluation system for digital stroke-patient rehabilitation assessment. Specifically, the study designed and developed a fusion device capable of emitting red, green, and infrared lights simultaneously for photoplethysmography (PPG) acquisition. Leveraging the different penetration depths and tissue reflection characteristics of these light wavelengths, the device can provide richer and more comprehensive physiological information. Furthermore, a Multi-Channel Convolutional Neural Network-Long Short-Term Memory-Attention (MCNN-LSTM-Attention) evaluation model was developed. This model, constructed based on multiple convolutional channels, facilitates the feature extraction and fusion of collected multi-modality data. Additionally, it incorporated an attention mechanism module capable of dynamically adjusting the importance weights of input information, thereby enhancing the accuracy of rehabilitation assessment. To validate the effectiveness of the proposed system, sixteen volunteers were recruited for clinical data collection and validation, comprising eight stroke patients and eight healthy subjects. Experimental results demonstrated the system's promising performance metrics (accuracy: 0.9125, precision: 0.8980, recall: 0.8970, F1 score: 0.8949, and loss function: 0.1261). This rehabilitation evaluation system holds the potential for stroke diagnosis and identification, laying a solid foundation for wearable-based stroke risk assessment and stroke rehabilitation assistance.

Gait training with a safety suspension device accelerates the achievement of supervision level walking in subacute stroke: a randomized controlled trial.

Practicing walking in a safety suspension device allows patients to move freely and without excessive reliance on a therapist, which requires correcting errors and may facilitate motor learning. This opens the possibility that patients with subacute stroke may improve their walking ability more rapidly. Therefore, we tested the hypothesis that overground gait training in a safety suspension device will result in achieving faster supervision-level walking than gait training without the suspension device. Twenty-seven patients with stroke admitted to the rehabilitation ward with functional ambulation categories (FAC) score of 2 at admission were randomly allocated to safety suspension-device group (SS group) or conventional assisted-gait training group (control group). In addition to regular physical therapy, each group underwent additional gait training for 60 min a day, 5 days a week for 4 weeks. We counted the days until reaching a FAC score of 3 and assessed the probability using Cox regression models. The median days required to reach a FAC score of 3 were 7 days for the SS group and 17.5 days for the control group, which was significantly different between the groups ( P  < 0.05). The SS group had a higher probability of reaching a FAC score of 3 after adjusting for age and admission motor impairment (hazard ratio = 3.61, 95% confidence interval = 1.40-9.33, P  < 0.01). The gait training with a safety suspension device accelerates reaching the supervision-level walking during inpatient rehabilitation. We speculate that a safety suspension device facilitated learning by allowing errors to be experienced and correct in a safe environment.

A Sensor-Based Upper Limb Treatment in Hemiplegic Patients: Results from a Randomized Pilot Study.

In post-stroke patients, the disabling motor deficit mainly affects the upper limb. The focus of rehabilitation is improving upper limb function and reducing long-term disability. This study aims to evaluate the feasibility of using the Gloreha Aria (R-Lead), a sensor-based upper limb in-hospital rehabilitation, compared with conventional physiotherapist-led training in subacute hemiplegic patients. Twenty-one patients were recruited and randomised 1:1 to a sensor-based group (treatment group TG) or a conventional group (control group, CG). All patients performed 30 sessions of 30 min each of dedicated upper limb rehabilitation. The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) was the primary evaluation., both as a motor score and as individual items. Secondary evaluations were Functional Independence Measure; global disability assessed with the Modified Barthel Index; Motor Evaluation Scale for UE in stroke; power grip; and arm, shoulder, and hand disability. All the enrolled patients, 10 in the TG and 11 in the CG, completed all hand rehabilitation sessions during their hospital stay without experiencing any adverse events. FMA-UE scores in upper limb motor function improved in both groups [delta change CG (11.8 ± 9.2) vs. TG (12.7 ± 8.6)]. The score at T1 for FMA joint pain (21.8 vs. 24 best score) suggests the use of the Gloreha Aria (R-Lead) as feasible in improving arm function abilities in post-stroke patients.

A Comprehensive Review: Robot-Assisted Treatments for Gait Rehabilitation in Stroke Patients.

Robot-assisted gait training (RAGT) is at the cutting edge of stroke rehabilitation, offering a groundbreaking method to improve motor recovery and enhance the quality of life for stroke survivors. This review investigates the effectiveness and application of various RAGT systems, including both end-effector and exoskeleton robots, in facilitating gait enhancements. The selection process for this comprehensive analysis involved a meticulous review of the literature from databases such as PubMed, the Cochrane Library, and EMBASE, focusing on studies published between 2018 and 2023. Ultimately, 27 studies met the criteria and were included in the final analysis. The focus of these studies was on the various RAGT systems and their role in promoting gait and balance improvements. The results of these studies conclusively show that patients experience significant positive effects from RAGT, and when combined with other physiotherapy methods, the outcomes are notably superior in enhancing functional ambulation and motor skills. This review emphasizes RAGT's capability to deliver a more customized and effective rehabilitation experience, highlighting the importance of tailoring interventions to meet the specific needs of each patient.

Utility and usability of a wearable system and progressive-challenge cued exercise program for encouraging use of the more involved arm at-home after stroke-a feasibility study with case reports.

BACKGROUND: Understanding the role of adherence to home exercise programs for survivors of stroke is critical to ensure patients perform prescribed exercises and maximize effectiveness of recovery. METHODS: Survivors of hemiparetic stroke with impaired motor function were recruited into a 7-day study designed to test the utility and usability of a low-cost wearable system and progressive-challenge cued exercise program for encouraging graded-challenge exercise at-home. The wearable system comprised two wrist-worn MetaMotionR+ activity monitors and a custom smartphone app. The progressive-challenge cued exercise program included high-intensity activities (one repetition every 30 s) dosed at 1.5 h per day, embedded within 8 h of passive activity monitoring per day. Utility was assessed using measures of system uptime and cue response rate. Usability and user experience were assessed using well-validated quantitative surveys of system usability and user experience. Self-efficacy was assessed at the end of each day on a visual analog scale that ranged from 0 to 100. RESULTS: The system and exercise program had objective utility: system uptime was 92 ± 6.9% of intended hours and the rate of successful cue delivery was 99 ± 2.7%. The system and program also were effective in motivating cued exercise: activity was detected within 5-s of the cue 98 ± 3.1% of the time. As shown via two case studies, accelerometry data can accurately reflect graded-challenge exercise instructions and reveal differentiable activity levels across exercise stages. User experience surveys indicated positive overall usability in the home settings, strong levels of personal motivation to use the system, and high degrees of satisfaction with the devices and provided training. Self-efficacy assessments indicated a strong perception of proficiency across participants (95 ± 5.0). CONCLUSIONS: This study demonstrates that a low-cost wearable system providing frequent haptic cues to encourage graded-challenge exercise after stroke can have utility and can provide an overall positive user experience in home settings. The study also demonstrates how combining a graded exercise program with all-day activity monitoring can provide insight into the potential for wearable systems to assess adherence to-and effectiveness of-home-based exercise programs on an individualized basis.

Human-centered design of a novel soft exosuit for post-stroke gait rehabilitation.

BACKGROUND: Stroke remains a major cause of long-term adult disability in the United States, necessitating the need for effective rehabilitation strategies for post-stroke gait impairments. Despite advancements in post-stroke care, existing rehabilitation often falls short, prompting the development of devices like robots and exoskeletons. However, these technologies often lack crucial input from end-users, such as clinicians, patients, and caregivers, hindering their clinical utility. Employing a human-centered design approach can enhance the design process and address user-specific needs. OBJECTIVE: To establish a proof-of-concept of the human-centered design approach by refining the NewGait® exosuit device for post-stroke gait rehabilitation. METHODS: Using iterative design sprints, the research focused on understanding the perspectives of clinicians, stroke survivors, and caregivers. Two design sprints were conducted, including empathy interviews at the beginning of the design sprint to integrate end-users' insights. After each design sprint, the NewGait device underwent refinements based on emerging issues and recommendations. The final prototype underwent mechanical testing for durability, biomechanical simulation testing for clinical feasibility, and a system usability evaluation, where the new stroke-specific NewGait device was compared with the original NewGait device and a commercial product, Theratogs®. RESULTS: Affinity mapping from the design sprints identified crucial categories for stakeholder adoption, including fit for females, ease of donning and doffing, and usability during barefoot walking. To address these issues, a system redesign was implemented within weeks, incorporating features like a loop-backed neoprene, a novel closure mechanism for the shoulder harness, and a hook-and-loop design for the waist belt. Additional improvements included reconstructing anchors with rigid hook materials and replacing latex elastic bands with non-latex silicone-based bands for enhanced durability. Further, changes to the dorsiflexion anchor were made to allow for barefoot walking. Mechanical testing revealed a remarkable 10-fold increase in durability, enduring 500,000 cycles without notable degradation. Biomechanical simulation established the modularity of the NewGait device and indicated that it could be configured to assist or resist different muscles during walking. Usability testing indicated superior performance of the stroke-specific NewGait device, scoring 84.3 on the system usability scale compared to 62.7 for the original NewGait device and 46.9 for Theratogs. CONCLUSION: This study successfully establishes the proof-of-concept for a human-centered design approach using design sprints to rapidly develop a stroke-specific gait rehabilitation system. Future research should focus on evaluating the clinical efficacy and effectiveness of the NewGait device for post-stroke rehabilitation.

Closed-Loop Wearable Device Network of Intrinsically-Controlled, Bilateral Coordinated Functional Electrical Stimulation for Stroke.

Innovative functional electrical stimulation has demonstrated effectiveness in enhancing daily walking and rehabilitating stroke patients with foot drop. However, its lack of precision in stimulating timing, individual adaptivity, and bilateral symmetry, resulted in diminished clinical efficacy. Therefore, a closed-loop wearable device network of intrinsically controlled functional electrical stimulation (CI-FES) system is proposed, which utilizes the personal surface myoelectricity, derived from the intrinsic neuro signal, as the switch to activate/deactivate the stimulation on the affected side. Simultaneously, it decodes the myoelectricity signal of the patient's healthy side to adjust the stimulation intensity, forming an intrinsically controlled loop with the inertial measurement units. With CI-FES assistance, patients' walking ability significantly improved, evidenced by the shift in ankle joint angle mean and variance from 105.53° and 28.84 to 102.81° and 17.71, and the oxyhemoglobin concentration tested by the functional near-infrared spectroscopy. In long-term CI-FES-assisted clinical testing, the discriminability in machine learning classification between patients and healthy individuals gradually decreased from 100% to 92.5%, suggesting a remarkable recovery tendency, further substantiated by performance on the functional movement scales. The developed CI-FES system is crucial for contralateral-hemiplegic stroke recovery, paving the way for future closed-loop stimulation systems in stroke rehabilitation is anticipated.

Comparison of Bipolar and Monopolar Electrode Configurations for FES on Biceps Brachii.

Function electrical stimulation (FES) is recommended as one of the effective methods for rehabilitation of motor function after stroke. There are two forms to deliver electrical stimulation to induce muscle contraction: Bipolar electrode configuration with two electrodes of the same size, and monopolar electrode configuration with a bigger electrode as an indifferent electrode and a smaller one as an active electrode. The purpose of this study is to compare the two kinds of configuration on biceps brachii in terms of induced muscle contraction force and muscle fatigue. In the experiment, electrical stimulation was applied on biceps brachii muscles of the right arm. Isometric contraction was induced by fixing the elbow joint during the stimulation. The experimental results showed that the induced contraction force was bigger using monopolar electrode configuration with the indifferent electrode on the antagonist muscle, and there was no significant difference in muscle fatigue between the configurations. Monopolar electrode configuration with the indifferent electrode on the antagonist muscle was suggested as the most effective method for FES on biceps brachii.Clinical Relevance- This study establishes an effective electrode configuration for FES on biceps brachii.

A structural analysis of the rail unit of an indoor assistive mobility system.

BACKGROUND: Individuals with gait disturbances, such as that post-stroke, are discharged home to undergo outpatient rehabilitation. Rehabilitation in the community is not as effective as that in hospital, due to long travel times and short program duration. OBJECTIVE: This study analyzed rail unit structure, with the aim of assisting home indoor assistive mobility system (HIAMS) development, allowing patients to undergo gait-related rehabilitation training at home. METHODS: The HIAMS consists of a mobile rail running around the whole room, a turn-table for movement between rails, and a weight-supporting component. Structural analysis was performed using the Abaqus/CAE solution (Version 6.14, Dassault systems, Inc.) to verify device safety, according to the load applied to the rail and turn-table units. The load was applied vertically at 150 kg to reflect the weight of potential users. RESULTS: Structural analysis was performed on the weight-supporting components, which was consist of turn-table case, bearing components (center, left), connective bracket and rail rollers. The safety factors of each components were estimated as 1.31, 5.39 (bearing, center), 8.45 (bearing, left), 1.43 and 3.61 in sequence. CONCLUSION: We demonstrated a safety factor of ⩾ 1.3 for the key system units, suggesting this technology is safe for use in the home rehabilitation training of individuals with gait impairment post-ICU stay.

Deep Convolution Generative Adversarial Network-Based Electroencephalogram Data Augmentation for Post-Stroke Rehabilitation with Motor Imagery.

The motor imagery brain-computer interface (MI-BCI) system is currently one of the most advanced rehabilitation technologies, and it can be used to restore the motor function of stroke patients. The deep learning algorithms in the MI-BCI system require lots of training samples, but the electroencephalogram (EEG) data of stroke patients is quite scarce. Therefore, the expansion of EEG data has become an important part of stroke clinical rehabilitation research. In this paper, a deep convolution generative adversarial network (DCGAN) model is proposed to generate artificial EEG data and further expand the scale of the stroke dataset. First, multichannel one-dimensional EEG data is converted into a two-dimensional EEG spectrogram using EEG2Image based on the modified S-transform. Then, DCGAN is used to artificially generate EEG data based on MI. Finally, the validity of the generated artificial EEG data is proved. This paper preliminarily indicates that generating artificial stroke data is a promising strategy, which contributes to the further development of stroke clinical rehabilitation.

Development and user experience of an innovative multi-mode stroke rehabilitation system for the arm and hand for patients with stroke.

Many individuals with stroke experience upper-limb motor deficits, and a recent trend is to develop novel devices for enhancing their motor function. This study aimed to develop a new upper-limb rehabilitation system with the integration of two rehabilitation therapies into one system, digital mirror therapy (MT) and action observation therapy (AOT), and to test the usability of this system. In the part I study, the new system was designed to operate in multiple training modes of digital MT (i.e., unilateral and bilateral modes) and AOT (i.e., pre-recorded and self-recorded videos) with self-developed software. In the part II study, 4 certified occupational therapists and 10 stroke patients were recruited for evaluating usability. The System Usability Scale (SUS) (maximum score = 100) and a self-designed questionnaire (maximum score = 50) were used. The mean scores of the SUS were 79.38 and 80.00, and those of the self-designed questionnaire were 41.00 and 42.80, respectively, for the therapists and patients after using this system, which indicated good usability and user experiences. This novel upper-limb rehabilitation system with good usability might be further used to increase the delivery of two emerging rehabilitation therapies, digital AOT and MT, to individuals with stroke.

Combining Optogenetic Stimulation and Motor Training Improves Functional Recovery and Perilesional Cortical Activity.

Background. An ischemic stroke is followed by the remapping of motor representation and extensive changes in cortical excitability involving both hemispheres. Although stimulation of the ipsilesional motor cortex, especially when paired with motor training, facilitates plasticity and functional restoration, the remapping of motor representation of the single and combined treatments is largely unexplored. Objective. We investigated if spatio-temporal features of motor-related cortical activity and the new motor representations are related to the rehabilitative treatment or if they can be specifically associated to functional recovery. Methods. We designed a novel rehabilitative treatment that combines neuro-plasticizing intervention with motor training. In detail, optogenetic stimulation of peri-infarct excitatory neurons expressing Channelrhodopsin 2 was associated with daily motor training on a robotic device. The effectiveness of the combined therapy was compared with spontaneous recovery and with the single treatments (ie optogenetic stimulation or motor training). Results. We found that the extension and localization of the new motor representations are specific to the treatment, where most treatments promote segregation of the motor representation to the peri-infarct region. Interestingly, only the combined therapy promotes both the recovery of forelimb functionality and the rescue of spatio-temporal features of motor-related activity. Functional recovery results from a new excitatory/inhibitory balance between hemispheres as revealed by the augmented motor response flanked by the increased expression of parvalbumin positive neurons in the peri-infarct area. Conclusions. Our findings highlight that functional recovery and restoration of motor-related neuronal activity are not necessarily coupled during post-stroke recovery. Indeed the reestablishment of cortical activation features of calcium transient is distinctive of the most effective therapeutic approach, the combined therapy.

Reward During Arm Training Improves Impairment and Activity After Stroke: A Randomized Controlled Trial.

BACKGROUND: Learning and learning-related neuroplasticity in motor cortex are potential mechanisms mediating recovery of movement abilities after stroke. These mechanisms depend on dopaminergic projections from midbrain that may encode reward information. Likewise, therapist experience confirms the role of feedback/reward for training efficacy after stroke. OBJECTIVE: To test the hypothesis that rehabilitative training can be enhanced by adding performance feedback and monetary rewards. METHODS: This multicentric, assessor-blinded, randomized controlled trial used the ArmeoSenso virtual reality rehabilitation system to train 37 first-ever subacute stroke patients in arm-reaching to moving targets. The rewarded group (n = 19) trained with performance feedback (gameplay) and contingent monetary reward. The control group (n = 18) used the same system without monetary reward and with graphically minimized performance feedback. Primary outcome was the change in the two-dimensional reaching space until the end of the intervention period. Secondary clinical assessments were performed at baseline, after 3 weeks of training (15 1-hour sessions), and at 3 month follow-up. Duration and intensity of the interventions as well as concomitant therapy were comparable between groups. RESULTS: The two-dimensional reaching space showed an overall improvement but no difference between groups. The rewarded group, however, showed significantly greater improvements from baseline in secondary outcomes assessing arm activity (Box and Block Test at post-training: 6.03±2.95, P = .046 and 3 months: 9.66±3.11, P = .003; Wolf Motor Function Test [Score] at 3 months: .63±.22, P = .007) and arm impairment (Fugl-Meyer Upper Extremity at 3 months: 8.22±3.11, P = .011). CONCLUSIONS: Although neutral in its primary outcome, the trial signals a potential facilitating effect of reward on training-mediated improvement of arm paresis. TRIAL REGISTRATION: ClinicalTrials.gov (ID: NCT02257125).

Abnormal synergistic gait mitigation in acute stroke using an innovative ankle-knee-hip interlimb humanoid robot: a preliminary randomized controlled trial.

Abnormal spasticity and associated synergistic patterns are the most common neuromuscular impairments affecting ankle-knee-hip interlimb coordinated gait kinematics and kinetics in patients with hemiparetic stroke. Although patients with hemiparetic stroke undergo various treatments to improve gait and movement, it remains unknown how spasticity and associated synergistic patterns change after robot-assisted and conventional treatment. We developed an innovative ankle-knee-hip interlimb coordinated humanoid robot (ICT) to mitigate abnormal spasticity and synergistic patterns. The objective of the preliminary clinical trial was to compare the effects of ICT combined with conventional physical therapy (ICT-C) and conventional physical therapy and gait training (CPT-G) on abnormal spasticity and synergistic gait patterns in 20 patients with acute hemiparesis. We performed secondary analyses aimed at elucidating the biomechanical effects of Walkbot ICT on kinematic (spatiotemporal parameters and angles) and kinetic (active force, resistive force, and stiffness) gait parameters before and after ICT in the ICT-C group. The intervention for this group comprised 60-min conventional physical therapy plus 30-min robot-assisted training, 7 days/week, for 2 weeks. Significant biomechanical effects in knee joint kinematics; hip, knee, and ankle active forces; hip, knee, and ankle resistive forces; and hip, knee, and ankle stiffness were associated with ICT-C. Our novel findings provide promising evidence for conventional therapy supplemented by robot-assisted therapy for abnormal spasticity, synergistic, and altered biomechanical gait impairments in patients in the acute post-stroke recovery phase.Trial Registration: Clinical Trials.gov identifier NCT03554642 (14/01/2020).

Self-Directed Exergaming for Stroke Upper Limb Impairment Increases Exercise Dose Compared to Standard Care.

Background. One of the strongest modifiable determinants of rehabilitation outcome is exercise dose. Technologies enabling self-directed exercise offer a pragmatic means to increase dose, but the extent to which they achieve this in unselected cohorts, under real-world constraints, is poorly understood. Objective. Here we quantify the exercise dose achieved by inpatient stroke survivors using an adapted upper limb (UL) exercise gaming (exergaming) device and compare this with conventional (supervised) therapy. Methods. Over 4 months, patients presenting with acute stroke and associated UL impairment were screened at a single stroke centre. Participants were trained in a single session and provided with the device for unsupervised use during their inpatient admission. Results. From 75 patients referred for inpatient UL therapy, we recruited 30 (40%), of whom 26 (35%) were able to use the device meaningfully with their affected UL. Over a median enrolment time of 8 days (IQR: 5-14), self-directed UL exercise duration using the device was 26 minutes per day (median; IQR: 16-31), in addition to 25 minutes daily conventional UL therapy (IQR: 12-34; same cohort plus standard care audit; joint n = 50); thereby doubling total exercise duration (51 minutes; IQR: 32-64) relative to standard care (Z = 4.0, P <.001). The device enabled 104 UL repetitions per day (IQR: 38-393), whereas conventional therapy achieved 15 UL repetitions per day (IQR: 11-23; Z = 4.3, P <.001). Conclusion. Self-directed adapted exergaming enabled participants in our stroke inpatient cohort to increase exercise duration 2-fold, and repetitions 8-fold, compared to standard care, without requiring additional professional supervision.

Wearable myoelectric interface enables high-dose, home-based training in severely impaired chronic stroke survivors.

BACKGROUND: High-intensity occupational therapy can improve arm function after stroke, but many people lack access to such therapy. Home-based therapies could address this need, but they don't typically address abnormal muscle co-activation, an important aspect of arm impairment. An earlier study using lab-based, myoelectric computer interface game training enabled chronic stroke survivors to reduce abnormal co-activation and improve arm function. Here, we assess feasibility of doing this training at home using a novel, wearable, myoelectric interface for neurorehabilitation training (MINT) paradigm. OBJECTIVE: Assess tolerability and feasibility of home-based, high-dose MINT therapy in severely impaired chronic stroke survivors. METHODS: Twenty-three participants were instructed to train with the MINT and game for 90 min/day, 36 days over 6 weeks. We assessed feasibility using amount of time trained and game performance. We assessed tolerability (enjoyment and effort) using a customized version of the Intrinsic Motivation Inventory at the conclusion of training. RESULTS: Participants displayed high adherence to near-daily therapy at home (mean of 82 min/day of training; 96% trained at least 60 min/day) and enjoyed the therapy. Training performance improved and co-activation decreased with training. Although a substantial number of participants stopped training, most dropouts were due to reasons unrelated to the training paradigm itself. INTERPRETATION: Home-based therapy with MINT is feasible and tolerable in severely impaired stroke survivors. This affordable, enjoyable, and mobile health paradigm has potential to improve recovery from stroke in a variety of settings. Clinicaltrials.gov: NCT03401762.

Application of fMRI and Simultaneous fMRI-EEG Neurofeedback in Post-Stroke Motor Rehabilitation.

This article discusses the contribution of fMRI- and fMRI-EEG-neurofeedback into recovery of motor function in two subacute stroke patients during the early post-stroke period. Premotor and supplementary motor zones of the cortex were chosen as the targets of voluntary control. Patient 1 received 6 sessions of motor imagery-based fMRI neurofeedback of secondary motor areas activity and Patient 2 received a similar course with the addition of µ- and ß-EEG activity suppression. Both reduced the motor deficit severity, improved on the quality of life, and increased the C3/C4 coherence to other central leads within EEG µ-band. Patient 1 reliably increased the fMRI signal in target areas and improved on the strength and speed of hand movements. Patient 2 (fMRI-EEG) mastered the EEG activity regulation to a greater degree. The authors conclude that pure fMRI neurofeedback and bi-modal fMRI-EEG neurofeedback produce different clinical effects in motor rehabilitation, which confirms the prospect of the closed-loop stroke treatment.

Exoskeleton-Assisted Anthropomorphic Movement Training (EAMT) for Poststroke Upper Limb Rehabilitation: A Pilot Randomized Controlled Trial.

OBJECTIVE: To investigate the feasibility of exoskeleton-assisted anthropomorphic movement training (EAMT) and its effects on upper extremity motor impairment, function, and kinematics after stroke. DESIGN: A single-blind pilot randomized controlled trial. SETTING: Stroke rehabilitation inpatient unit. PARTICIPANTS: Participants with a hemiplegia (N=20) due to a first-ever, unilateral, subacute stroke who had a score of 8-47 on the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). INTERVENTIONS: The exoskeleton group received EAMT therapy that provided task-specific training under anthropomorphic trajectories and postures. The control group received conventional upper limb therapy. For both groups, therapy was delivered at the same intensity, frequency, and duration: 45 minutes daily, 5 days per week, for 4 weeks. MAIN OUTCOME MEASURES: Primary outcome: feasibility analysis. SECONDARY OUTCOMES: FMA-UE, Action Research Arm Test (ARAT), modified Barthel Index (MBI), and kinematic metrics during exoskeleton therapy. RESULTS: Twenty participants with subacute stroke were recruited and completed all therapy sessions. EAMT therapy was feasible and acceptable for the participants. The recruitment rate, retention rate, and number of therapists required for EAMT therapy were acceptable compared with other robotic trials. EAMT was determined to be safe, as no adverse event occurred except tolerable muscle fatigue in 2 participants. There were significant between-group differences in the change scores of FMA-UE (difference, 4.30 points; P=.04) and MBI (difference, 8.70 points; P=.03) in favor of EAMT therapy. No significant between-group difference was demonstrated for the change scores of ARAT (P=.18). Participants receiving EAMT showed significant improvements in kinematic metrics after treatment (P<.01). CONCLUSIONS: Our results indicate that EAMT is a feasible approach and may improve upper extremity motor impairment, activities of daily living, and kinematics after stroke. However, fully powered randomized controlled trials are warranted to confirm the results of this pilot study and explore the underlying mechanisms by which EAMT therapy might work.

Evidence of neuroplasticity with robotic hand exoskeleton for post-stroke rehabilitation: a randomized controlled trial.

BACKGROUND: A novel electromechanical robotic-exoskeleton was designed in-house for the rehabilitation of wrist joint and Metacarpophalangeal (MCP) joint. OBJECTIVE: The objective was to compare the rehabilitation effectiveness (clinical-scales and neurophysiological-measures) of robotic-therapy training sessions with dose-matched conventional therapy in patients with stroke. METHODS: A pilot prospective parallel randomized controlled study at clinical settings was designed for patients with stroke within 2 years of chronicity. Patients were randomly assigned to receive an intervention of 20 sessions of 45 min each, five days a week for four weeks, in Robotic-therapy Group (RG) (n = 12) and conventional upper-limb rehabilitation in Control-Group (CG) (n = 11). We intended to evaluate the effects of a novel exoskeleton based therapy on the functional rehabilitation outcomes of upper-limb and cortical-excitability in patients with stroke as compared to the conventional-rehabilitation. Clinical-scales- Modified Ashworth Scale, Active Range of Motion, Barthel-Index, Brunnstrom-stage and Fugl-Meyer (FM) scale and neurophysiological measures of cortical-excitability (using Transcranial Magnetic Stimulation) -Motor Evoked Potential and Resting Motor threshold, were acquired pre- and post-therapy. RESULTS: No side effects were noticed in any of the patients. Both RG and CG showed significant (p < 0.05) improvement in all clinical motor-outcomes except Modified Ashworth Scale in CG. RG showed significantly (p < 0.05) higher improvement over CG in Modified Ashworth Scale, Active Range of Motion and Fugl-Meyer scale and FM Wrist-/Hand component. An increase in cortical-excitability in ipsilesional-hemisphere was found to be statistically significant (p < 0.05) in RG over CG, as indexed by a decrease in Resting Motor Threshold and increase in the amplitude of Motor Evoked Potential. No significant changes were shown by the contralesional-hemisphere. Interhemispheric RMT-asymmetry evidenced significant (p < 0.05) changes in RG over CG indicating increased cortical-excitability in ipsilesional-hemisphere along with interhemispheric changes. CONCLUSION: Robotic-exoskeleton training showed improvement in motor outcomes and cortical-excitability in patients with stroke. Neurophysiological changes in RG could most likely be a consequence of plastic reorganization and use-dependent plasticity. Trial registry number: ISRCTN95291802.

Upper limbs cycle ergometer increases muscle strength, trunk control and independence of acute stroke subjects: A randomized clinical trial.

BACKGROUND: Studies demonstrate the benefits of upper limbs cycle ergometer (ULCE) in subacute and chronic stroke subjects, but the literature still needs to explore the acute phase of the disease. OBJECTIVE: Verify the effects of ULCE on muscular strength, trunk control and independence of post-stroke subjects in hospital acute phase. METHODS: In this randomized clinical trial participants were allocated into two groups. The control group (CG) performed two daily sessions of conventional physiotherapy, while the intervention group (IG) had one daily session of conventional physiotherapy and one of ULCE. The interventions were carried out for 20 minutes for five days. Both groups were assessed before and after the treatment for upper limbs strength by manual dynamometer, trunk control by Trunk Impairment Scale and level of independence by the Modified Rankin Scale. RESULTS: Twenty subjects with mean ages of 63.5±4.5 were enrolled. There was a significant intra-group difference of palmar grip, shoulder abductors, elbow flexor and wrist extensor strength, trunk control and functional independence only in IG. Inter-group difference for all variables showed superiority in IG. CONCLUSIONS: ULCE is an effective device for increasing muscle strength, trunk control and consequently improving the independence of post-stroke subjects in the acute hospital phase.