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Enriched environments and tools are believed to promote grasp rehabilitation after stroke. We designed S2, an interactive grasp rehabilitation system consisting of smart objects, custom orthoses for selective grasp constraining, and an electrode array system for forearm NMES. Motor improvements and perceived usability of a new enriched upper limb training system for sub-acute stroke patients was assessed in this interim analysis. INCLUSION CRITERIA: sub-acute stroke patients with MMSE>20, ipsilesional MI>80%, and contralesional MI<80%. Effects of 30-min therapy supplements, conventional vs. S2 prototype, are compared through a parallel two-arms dose-matched open-label trial, lasting 27 sessions. Clinical centres: Asklepios Neurologische Klinik Falkenstein, Königstein im Taunus, Germany, and Clinica Villa Beretta, Costa Masnaga, Italy. Assessment scales: ARAT, System Usability, and Technology Acceptance. METHODOLOGY: 26 participants were block randomized, allocated to the study (control N=12, experimental N=14) and underwent the training protocol. Among them, 11 participants with ARAT score at inclusion below 35, n = 6 in the experimental group, and n = 5 in the control group were analysed. RESULTS: participants in the enriched treatment group displayed a larger improvement in the ARAT scale (+14.9 pts, pval=0.0494). Perceived usability differed between clinics. No adverse effect was observed in relation to the treatments. Trial status: closed. CONCLUSIONS: The S2 system, developed according to shared clinical directives, was tested in a clinical proof of concept. Variations of ARAT scores confirm the feasibility of clinical investigation for hand rehabilitation after stroke.
Assuntos
Reabilitação do Acidente Vascular Cerebral , Acidente Vascular Cerebral , Terapia por Exercício , Força da Mão , Humanos , Recuperação de Função Fisiológica , Resultado do Tratamento , Extremidade SuperiorRESUMO
BACKGROUND: Participation in physical and therapeutic activities is usually severely restricted after a spinal cord injury (SCI). Reasons for this are the associated loss of voluntary motor function, inefficient temperature regulation of the affected extremities, and early muscle fatigue. Hydrotherapy or swim training offer an inherent weight relief, reduce spasticity and improve coordination, muscle strength and fitness. METHODS: We present a new hybrid exercise modality that combines functional electrical stimulation (FES) of the knee extensors and transcutaneous spinal cord stimulation (tSCS) with paraplegic front crawl swimming. tSCS is used to stimulate the afferent fibers of the L2-S2 posterior roots for spasticity reduction. By activating the tSCS, the trunk musculature is recruited at a motor level. This shall improve trunk stability and straighten the upper body. Within this feasibility study, two complete SCI subjects (both ASIA scale A, lesion level Th5/6), who have been proficient front crawl swimmers, conducted a 10-week swim training with stimulation support. In an additional assessment swim session nine months after the training, the knee extension, hip extension, and trunk roll angles where measured using waterproof inertial measurement units (IMUs) and compared for different swimming conditions (no stimulation, tSCS, FES, FES plus tSCS). RESULTS: For both subjects, a training effect over the 10-week swim training was observed in terms of measured lap times (16 m pool) for all swimming conditions. Swimming supported by FES reduced lap times by 15.4% and 8.7% on average for Subject A and Subject B, respectively. Adding tSCS support yielded even greater mean decreases of 19.3% and 20.9% for Subjects A and B, respectively. Additionally, both subjects individually reported that swimming with tSCS for 30-45 minutes eliminated spasticity in the lower extremities for up to 4 hours beyond the duration of the session. Comparing the median as well as the interquartile range of all different settings, the IMU-based motion analysis revealed that FES as well as FES+tSCS improve knee extension in both subjects, while hip extension was only increased in one subject. Trunk roll angles were similar for all swimming conditions. tSCS had no influence on the knee and hip joint angles. Both subjects reported that stimulation-assisted swimming is comfortable, enjoyable, and they would like to use such a device for recreational training and rehabilitation in the future. CONCLUSIONS: Stimulation-assisted swimming seems to be a promising new form of hybrid exercise for SCI people. It is safe to use with reusable silicone electrodes and can be performed independently by experienced paraplegic swimmers except for transfer to water. The study results indicate that swimming speed can be increased by the proposed methods and spasticity can be reduced by prolonged swim sessions with tSCS and FES. The combination of stimulation with hydrotherapy might be a promising therapy for neurologic rehabilitation in incomplete SCI, stroke or multiples sclerosis patients. Therefore, further studies shall incorporate other neurologic disorders and investigate the potential benefits of FES and tSCS therapy in the water for gait and balance.
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Terapia por Estimulação Elétrica/métodos , Terapia por Exercício/métodos , Paraplegia/reabilitação , Traumatismos da Medula Espinal/reabilitação , Natação/fisiologia , Adulto , Terapia por Estimulação Elétrica/instrumentação , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Espasticidade Muscular/etiologia , Espasticidade Muscular/reabilitação , Paraplegia/etiologia , Projetos Piloto , Traumatismos da Medula Espinal/complicaçõesRESUMO
Goal: Parkinson's disease (PD) can lead to gait impairment and Freezing of Gait (FoG). Recent advances in cueing technologies have enhanced mobility in PD patients. While sensor technology and machine learning offer real-time detection for on-demand cueing, existing systems are limited by the usage of smartphones between the sensor(s) and cueing device(s) for data processing. By avoiding this we aim at improving usability, robustness, and detection delay. Methods: We present a new technical solution, that runs detection and cueing algorithms directly on the sensing and cueing devices, bypassing the smartphone. This solution relies on edge computing on the devices' hardware. The wearable system consists of a single inertial sensor to control a stimulator and enables machine-learning-based FoG detection by classifying foot motion phases as either normal or FoG-affected. We demonstrate the system's functionality and safety during on-demand gait-synchronous electrical cueing in two patients, performing freezing of gait assessments. As references, motion phases and FoG episodes have been video-annotated. Results: The analysis confirms adequate gait phase and FoG detection performance. The mobility assistant detected foot motions with a rate above 94 % and classified them with an accuracy of 84 % into normal or FoG-affected. The FoG detection delay is mainly defined by the foot-motion duration, which is below the delay in existing sliding-window approaches. Conclusions: Direct computing on the sensor and cueing devices ensures robust detection of FoG-affected motions for on demand cueing synchronized with the gait. The proposed solution can be easily adopted to other sensor and cueing modalities.
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BACKGROUND: Robotic systems combined with Functional Electrical Stimulation (FES) showed promising results on upper-limb motor recovery after stroke, but adequately-sized randomized controlled trials (RCTs) are still missing. OBJECTIVE: To evaluate whether arm training supported by RETRAINER, a passive exoskeleton integrated with electromyograph-triggered functional electrical stimulation, is superior to advanced conventional therapy (ACT) of equal intensity in the recovery of arm functions, dexterity, strength, activities of daily living, and quality of life after stroke. METHODS: A single-blind RCT recruiting 72 patients was conducted. Patients, randomly allocated to 2 groups, were trained for 9 weeks, 3 times per week: the experimental group performed task-oriented exercises assisted by RETRAINER for 30 minutes plus ACT (60 minutes), whereas the control group performed only ACT (90 minutes). Patients were assessed before, soon after, and 1 month after the end of the intervention. Outcome measures were as follows: Action Research Arm Test (ARAT), Motricity Index, Motor Activity Log, Box and Blocks Test (BBT), Stroke Specific Quality of Life Scale (SSQoL), and Muscle Research Council. RESULTS: All outcomes but SSQoL significantly improved over time in both groups (P < .001); a significant interaction effect in favor of the experimental group was found for ARAT and BBT. ARAT showed a between-group change of 11.5 points (P = .010) at the end of the intervention, which increased to 13.6 points 1 month after. Patients considered RETRAINER moderately usable (System Usability Score of 61.5 ± 22.8). CONCLUSIONS: Hybrid robotic systems, allowing to perform personalized, intensive, and task-oriented training, with an enriched sensory feedback, was superior to ACT in improving arm functions and dexterity after stroke.
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Terapia por Estimulação Elétrica , Eletromiografia , Terapia por Exercício , Exoesqueleto Energizado , Recuperação de Função Fisiológica , Reabilitação do Acidente Vascular Cerebral , Acidente Vascular Cerebral/terapia , Extremidade Superior , Atividades Cotidianas , Adulto , Idoso , Idoso de 80 Anos ou mais , Terapia Combinada , Terapia por Estimulação Elétrica/instrumentação , Terapia por Estimulação Elétrica/métodos , Terapia por Exercício/instrumentação , Terapia por Exercício/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Qualidade de Vida , Recuperação de Função Fisiológica/fisiologia , Robótica , Método Simples-Cego , Acidente Vascular Cerebral/fisiopatologia , Reabilitação do Acidente Vascular Cerebral/instrumentação , Reabilitação do Acidente Vascular Cerebral/métodos , Extremidade Superior/fisiopatologiaRESUMO
OBJECTIVE: To develop and evaluate a hybrid robotic system for arm recovery after stroke, combining ElectroMyoGraphic (EMG)-triggered functional electrical stimulation (FES) with a passive exoskeleton for upper limb suspension. METHODS: The system was used in a structured exercise program resembling activities of daily life. Exercises execution was continuously controlled using angle sensor data and radio-frequency identification technology. The training program consisted of 27 sessions lasting 30 min each. Seven post-acute stroke patients were recruited from two clinical sites. The efficacy of the system was evaluated in terms of action research arm test, motricity index, motor activity log, and box & blocks tests. Furthermore, kinematics-based and EMG-based outcome measures were derived directly from data collected during training sessions. RESULTS: All patients showed an improvement of motor functions at the end of the training program. After training, the exercises were in most cases executed faster, smoother, and with an increased range of motion. Subjects were able to trigger FES, but in some cases, they did not maintain the voluntary effort during task execution. All subjects but one considered the system usable. CONCLUSION: The preliminary results showed that the system can be used in a clinical environment with positive effects on arm functional recovery. However, only the final results of the currently ongoing clinical trial will unveil the system's full potential. SIGNIFICANCE: The presented hybrid robotic system is highly customizable, allows to monitor the daily performance, requires low supervision of the therapist, and might have the potential to enhance arm recovery after stroke.