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In this study, we conducted a survey targeting 191 physical therapists (PTs) and 159 occupational therapists (OTs) in South Korea to explore attitudes toward virtual rehabilitation. Utilizing the Korean version of the ADOPT VR by Glegg et al., OT exhibited significantly more experience with virtual reality (VR) and active video games (AVG) than PT. Therapists with VR/AVG experience scored significantly higher in most categories, and the scores in each category were significantly correlated with the Behavioral Intention category, reflecting the willingness to use VR/AVG. The biggest barriers identified were insufficient funds and setup assistance for the equipment. Differences in responses between the groups with and without VR/AVG experience were most prominent in terms of lack of interest and funding. Therapists' attitudes, perceptions, and intentions toward VR/AVG are crucial factors in the establishment and implementation of VR/AVG; thus, the results of this study provide valuable evidence for future policies related to VR/AVG in rehabilitation medicine.
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BACKGROUND: Depression and anxiety may be significant prognostic factors after myocardial infarction (MI). Thus, we investigated depression and anxiety prevalence among older MI survivors and their impact on mortality, stroke, and recurrent MI. METHODS: This population-based cohort study used the Korean National Health Insurance Service database for data concerning individuals aged 66 years who participated in the National Screening Program from 2009 to 2016. Overall, 11,721 individuals with MI history and 58,605 age- and sex-matched controls were included and followed up until 2019. The presence of depression and anxiety was assessed 2 years before and after participation in the program. Mortality and major adverse outcomes, defined as a composite outcome comprising mortality, stroke, and recurrent MI, were analyzed. RESULTS: Depression and anxiety prevalence among MI survivors was 20.4 % and 30.3 %, respectively. Crude odds ratios for depression and anxiety, compared with the control group, were 1.207 (1.148-1.269) and 1.078 (1.032-1.126), respectively. During the follow-up, individuals with depression, anxiety, or both showed increased hazard ratios (HRs) for mortality and major adverse outcomes; after adjustments, their HRs were 1.442 (1.182-1.759), 1.129 (0.960-1.328), and 1.498 (1.263-1.776), respectively, for mortality and 1.505 (1.289-1.758), 1.158 (1.021-1.314), and 1.530 (1.337-1.751), respectively, for major adverse outcomes. LIMITATIONS: Although this was a nationwide cohort study, the MI, depression, and anxiety diagnoses were based on diagnostic codes. CONCLUSIONS: Higher depression and anxiety prevalence was observed among older MI survivors. Depression and anxiety occurrence correlated with increased adverse clinical outcomes after adjustments.
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Infarto del Miocardio , Accidente Cerebrovascular , Humanos , Estudios de Cohortes , Depresión/epidemiología , Depresión/diagnóstico , Prevalencia , Infarto del Miocardio/epidemiología , Ansiedad/epidemiología , Ansiedad/diagnóstico , Sobrevivientes , Factores de RiesgoRESUMEN
Cerebellar brain inhibition (CBI), a neural connection between the cerebellum and primary motor cortex (M1), has been researched as a target pathway for neuromodulation to improve clinical outcomes in various neurological diseases. However, conflicting results of anodal cerebellar transcranial direct current stimulation (acb-tDCS) on M1 excitability indicate that additional investigation is required to examine its precise effect. This study aimed to gather evidence of the neuromodulatory effect of acb-tDCS on the M1 using functional near-infrared spectroscopy (fNIRS). Sixteen healthy participants were included in this cross-over study. Participants received real and sham acb-tDCS randomly, with a minimum 1-week washout period between them. The anode and cathode were placed on the right cerebellum and the right buccinator muscle, respectively. Stimulation lasted 20 min at an intensity of 2 mA, and fNIRS data were recorded for 42 min (including a 4-min baseline before stimulation and an 18-min post-stimulation duration) using eight channels attached bilaterally on the M1. acb-tDCS induced a significant decrease in oxyhemoglobin (HbO) concentration (inhibitory effect) in the left (contralateral) M1, whereas it induced a significant increase in HbO concentration (excitatory effect) in the right (ipsilateral) M1 compared to sham tDCS during (p < 0.05) and after stimulation (p < 0.01) in a group level analysis. At the individual level, variations in response to acb-tDCS were observed. Our findings demonstrate the neuromodulatory effects of acb-tDCS on the bilateral M1 in terms of neuronal hemodynamics.
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Corteza Motora , Estimulación Transcraneal de Corriente Directa , Humanos , Estimulación Transcraneal de Corriente Directa/métodos , Espectroscopía Infrarroja Corta , Corteza Motora/fisiología , Estudios Cruzados , Cerebelo/fisiología , Electrodos , Potenciales Evocados Motores/fisiologíaRESUMEN
Botulinum toxin type A (BTX-A) injection is a commonly used therapeutic intervention for upper limb spasticity in stroke patients. This study was designed as a randomized, active-drug-controlled, double-blind, multicenter, phase 3 clinical trial to evaluate the safety and efficacy of Liztox® in comparison to onabotulinum toxin A (Botox®) for individuals with post-stroke upper limb spasticity. The primary outcome was the alteration in wrist flexor muscle tone from the initial assessment to the fourth week, evaluated using the modified Ashworth scale (MAS). Secondary outcomes included MAS score changes for the wrist at weeks 8 and 12 from baseline; MAS score changes for finger and elbow flexors; and changes in the Disability Assessment Scale (DAS), Subject's Global Assessment (SGA), the Investigator's Global Assessment (IGA), and Caregiver Burden Scale (CBS) at weeks 4, 8, and 12 from baseline. The MAS score for wrist flexor spasticity decreased by -1.14 ± 0.59 in the Liztox® group and -1.22 ± 0.59 in the Botox® group from baseline to week 4. The difference [97.5% confidence interval (CI)] between the test and control groups was 0.08 [-∞, 0.26], confirming the non-inferiority of the test group compared to the control group. Furthermore, there were consistent improvements in the IGA, SGA, and CBS scores across all assessment intervals, with no statistically significant variances detected between the two groups. No safety-related concerns were reported during the study. In conclusion, Liztox® injection proved to be a secure and efficacious intervention for managing upper extremity spasticity in post-stroke patients.
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Toxinas Botulínicas Tipo A , Fármacos Neuromusculares , Accidente Cerebrovascular , Humanos , Toxinas Botulínicas Tipo A/efectos adversos , Fármacos Neuromusculares/efectos adversos , Resultado del Tratamiento , Extremidad Superior , Accidente Cerebrovascular/complicaciones , Accidente Cerebrovascular/tratamiento farmacológico , Espasticidad Muscular/tratamiento farmacológico , Espasticidad Muscular/etiología , Método Doble Ciego , Inmunoglobulina ARESUMEN
OBJECTIVE: : To translate the 22-item Longer-term Unmet Needs after Stroke (LUNS) questionnaire, validate it in the Korean stroke population, and assess the reliability of face-to-face and telephone surveys. METHODS: : Sixty-six adult patients with stroke from Seoul National University Bundang Hospital and Kangwon National University Hospital were involved in the validation. Participants were interviewed twice using the LUNS Korean version: first, a face-to-face survey for validation, and second, a telephone survey for test-retest reliability. Participants completed the Frenchay Activities Index (FAI) and Short Form 12 (SF-12) Mental and Physical Component Summary (MCS and PCS) scores at the first interview. For concurrent validity, the differences in health status (FAI, SF-12 MCS and PCS) between the groups that reported unmet needs and those that did not were analyzed for each item. Cohen's kappa and percentage of agreement between the first and second administrations were calculated for each item to determine the test-retest reliability. RESULTS: : The average age of the participants was 61.2±12.8 years and 74.2% were male. Fifty-seven patients were involved in the second interview. Depending on the unmet needs, SF-12 MCS, PCS, and FAI were significantly different in 12 of 22 items. In the test-retest reliability test, 12 items had a kappa of 0.6 or higher, and two had a kappa of <0.4. CONCLUSION: : The LUNS instrument into Korean (LUNS-K) is a reliable and valid instrument for assessing unmet health needs in patients with stroke. In addition, telephone surveys can be considered reliable.
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Introduction: The incidence of stroke is increasing steadily due to factors such as population aging. Approximately 80% of stroke survivors have motor disorders affecting their daily lives. Repetitive transcranial magnetic stimulation (rTMS) has been reported to maximize functional recovery after stroke along with exercise intervention in upper limb rehabilitation treatment. However, whether rTMS affects the recovery of upper limb function in patients with stroke remains unclear. Therefore, in this trial, we will investigate the efficacy of low-frequency rTMS in patients with subcortical and brainstem ischemic stroke. Methods: This study has been designed as a multi-center, double-blind, randomized controlled trial to compare the efficacy of low-frequency rTMS over the contralesional M1 with sham stimulation. Overall, 88 participants will be allocated to the intervention or control group in a 1:1 ratio, with stratification according to their initial upper extremity Fugl-Meyer assessment (UE-FMA) score. The participants will receive either 30 min of real rTMS (intervention group) or sham rTMS (control group), followed by 30 min of occupational therapy for 10 consecutive workdays. All the participants will receive the same amount of rehabilitation therapy throughout the intervention period. Evaluations will be performed at baseline (T0), at the end of treatment (T1), and 4 weeks after the end of treatment (T2), including the box and block test (BBT), UE-FMA, Korean version of the Modified Barthel Index, and NIH Stroke Scale scores, Finger tapping test, Brunnstrom stage, modified Ashworth scale, and grip strength. The primary outcome will be the change in the BBT score between T0 and T2. Conclusion: This study will provide evidence on the efficacy of low-frequency rTMS in motor function recovery of the upper limb in patients with subacute, subcortical, and brainstem ischemic stroke. Clinical trial registration: ClinicalTrials.gov, identifier [NCT05535504].
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We investigated the activation pattern of the motor cortex (M1) and parietal cortex during immersive virtual reality (VR)-based mirror visual feedback (MVF) of the upper limb in 14 patients with chronic stroke and severe upper limb hemiparesis and in 21 healthy controls. Participants performed wrist extension with unaffected wrists (dominant side in controls). In the MVF condition, movement of the affected hand was synchronized with that of the unaffected hand. In the no-MVF condition, only the movement of unaffected hand was shown. Mu suppression in bilateral M1 and parietal cortex and mu coherence were analyzed. In patients with stroke, MVF induced significant mu suppression in both the ipsilesional M1 and parietal lobes (p = 0.006 and p = 0.009, respectively), while mu suppression was observed in the bilateral M1 (p = 0.003 for ipsilesional and p = 0.041 for contralesional M1, respectively) and contralesional parietal lobes in the controls (p = 0.036). The ipsilesional mu coherence between the M1 and parietal cortex in patients with stroke was stronger than controls, regardless of MVF condition (p < 0.001), while mu coherence between interhemispheric M1 cortices was significantly weaker in patients with stroke (p = 0.032). Our findings provide evidence of the neural mechanism of MVF using immersive VR in patients with stroke.
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Corteza Motora , Rehabilitación de Accidente Cerebrovascular , Accidente Cerebrovascular , Humanos , Retroalimentación Sensorial/fisiología , Corteza Motora/fisiología , Lóbulo ParietalRESUMEN
This clinical practice guideline (CPG) is the fourth edition of the Korean guideline for stroke rehabilitation, which was last updated in 2016. The development approach has been changed from a consensus-based approach to an evidence-based approach using the Grading of Recommendations Assessment Development and Evaluation (GRADE) method. This change ensures that the guidelines are based on the latest and strongest evidence available. The aim is to provide the most accurate and effective guidance to stroke rehabilitation teams, and to improve the outcomes for stroke patients in Korea. Fifty-five specialists in stroke rehabilitation and one CPG development methodology expert participated in this development. The scope of the previous clinical guidelines was very extensive, making it difficult to revise at once. Therefore, it was decided that the scope of this revised CPG would be limited to Part 1: Rehabilitation for Motor Function. The key questions were selected by considering the preferences of the target population and referring to foreign guidelines for stroke rehabilitation, and the recommendations were completed through systematic literature review and the GRADE method. The draft recommendations, which were agreed upon through an official consensus process, were refined after evaluation by a public hearing and external expert evaluation.
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Alteration of electroencephalography (EEG) signals during task-specific movement of the impaired limb has been reported as a potential biomarker for the severity of motor impairment and for the prediction of motor recovery in individuals with stroke. When implementing EEG experiments, detailed paradigms and well-organized experiment protocols are required to obtain robust and interpretable results. In this protocol, we illustrate a task-specific paradigm with upper limb movement and methods and techniques needed for the acquisition and analysis of EEG data. The paradigm consists of 1 min of rest followed by 10 trials comprising alternating 5 s and 3 s of resting and task (hand extension)-states, respectively, over 4 sessions. EEG signals were acquired using 32 Ag/AgCl scalp electrodes at a sampling rate of 1,000 Hz. Event-related spectral perturbation analysis associated with limb movement and functional network analyses at the global level in the low-beta (12-20 Hz) frequency band were performed. Representative results showed an alteration of the functional network of low-beta EEG frequency bands during movement of the impaired upper limb, and the altered functional network was associated with the degree of motor impairment in chronic stroke patients. The results demonstrate the feasibility of the experimental paradigm in EEG measurements during upper limb movement in individuals with stroke. Further research using this paradigm is needed to determine the potential value of EEG signals as biomarkers of motor impairment and recovery.
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Rehabilitación de Accidente Cerebrovascular , Accidente Cerebrovascular , Humanos , Accidente Cerebrovascular/diagnóstico , Extremidad Superior , Electroencefalografía/métodos , Mano , Rehabilitación de Accidente Cerebrovascular/métodosRESUMEN
The prevalence of dysphagia is increasing, resulting in socioeconomic burden, but previous reports have only been based on a limited populations. Therefore, we aimed to investigate the nationwide incidence and prevalence of dysphagia requiring medical attention to provide adequate information for healthcare planning and resource allocation. In this nationwide retrospective cohort study, the data of adults aged ≥20 years recorded from 2006 to 2016 were sourced from the Korean National Health Insurance Service database. Medical claim codes based on ICD-10-CM were used to define dysphagia and possible causes. The annual incidence and prevalence of dysphagia were calculated. Cox regression was used to estimate dysphagia risk in people with possible dysphagia etiology. Survival analysis was performed to estimate the mortality and hazard ratio of dysphagia. The crude annual incidence of dysphagia increased continuously from 7.14 in 2006 to 15.64 in 2016. The crude annual prevalence of dysphagia in 2006 was 0.09% and increased annually to 0.25% in 2016. Stroke (odds ratio [OR]: 7.86, 95% confidence interval [CI]: 5.76-6.68), neurodegenerative disease (OR: 6.20, 95% CI: 5.76-6.68), cancer (OR: 5.59, 95% CI: 5.17-6.06), and chronic obstructive pulmonary disease (OR: 2.94, 95% CI: 2.71-3.18) were associated with a high risk of dysphagia. The mortality in the dysphagia group was 3.12 times higher than that in the non-dysphagia group (hazard ratio: 3.12, 95% CI: 3.03-3.23). The incidence and prevalence of dysphagia requiring medical attention are increasing annually. The increasing trend was conspicuous in the geriatric population. The presence of stroke, neurodegenerative disease, cancer, and chronic obstructive pulmonary disease is associated with a high risk of dysphagia. Therefore, adequate screening, diagnosis, and management of dysphagia in the older population must be emphasized in geriatric healthcare.
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Trastornos de Deglución , Neoplasias , Enfermedades Neurodegenerativas , Enfermedad Pulmonar Obstructiva Crónica , Accidente Cerebrovascular , Adulto , Humanos , Anciano , Incidencia , Prevalencia , Estudios Retrospectivos , Trastornos de Deglución/epidemiología , República de Corea/epidemiologíaRESUMEN
PURPOSE: Most previous reports on dysphagia in cancer have focused on specific cancer types, particularly head and neck cancer. Therefore, we aimed to investigate the incidence of dysphagia in patients with various cancers using a nationwide database in South Korea. METHODS: This was a retrospective cohort study using the National Health Insurance Service database. Claim codes were used for the selection criteria and operational definitions. The total population data from 2010 to 2015 were extracted. The crude incidence of dysphagia was calculated per 1,000 person-years. The multivariate adjusted Cox proportional hazards regression was used to determine the effects of different cancers on the incidence of dysphagia. RESULTS: People with cancer had a lower income and suffered from a higher risk of comorbidities compared to people without cancer. The risk of dysphagia increased in all types of cancers, particularly in the oral cavity and pharynx (hazard ratio [HR]: 20.65, 95% confidence interval [CI]: 17.73-24.06), esophagus (HR: 18.25, 95% CI: 15.66-21.26), larynx (HR: 12.87, 95% CI: 10.33-16.02), and central nervous system (HR: 12.42, 95% CI: 10.33-14.94). CONCLUSIONS: The risk of dysphagia was significantly higher in the cancer group than in the non-cancer group. As the survival of cancer patients is improving with the development of new treatments, more attention should be paid to dysphagia in the management of cancer. Prompt and appropriate multidisciplinary interventions for dysphagia are necessary to improve the recovery and quality of life in cancer patients.
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Trastornos de Deglución , Neoplasias de Cabeza y Cuello , Humanos , Estudios Retrospectivos , Estudios de Cohortes , Trastornos de Deglución/epidemiología , Trastornos de Deglución/etiología , Incidencia , Calidad de Vida , Factores de Riesgo , Neoplasias de Cabeza y Cuello/complicaciones , Neoplasias de Cabeza y Cuello/epidemiología , Modelos de Riesgos ProporcionalesRESUMEN
The attitude toward telerehabilitation (TR) among therapists (191 physical therapists and 159 occupational therapists) in Korea was surveyed. The survey consisted of 15 questions in the following 8 domains: awareness(AW), attitude (AT), perceived usefulness (PU), perceived behavioral control (PBC), self-efficacy (SE), facilitating conditions (FC), barriers (B), and behavioral intention (BI). Therapists with experience in TR responded with higher scores in all domains except B, regardless of their specialty. The most perceived barriers to TR were unmatched insurance fees and a lack of technical support. Experience with TR was a major factor in attitude and behavior intention toward TR.
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BACKGROUND: Patients with Parkinson's disease (PD) experience both motor and non-motor symptoms, including dysphagia. Although PD is closely associated with dysphagia, the prevalence or risk of dysphagia in PD is unclear, especially in Asian countries. METHODS: The prevalence of PD and dysphagia with PD in the general population was analyzed using the Korean National Health Insurance Service (NHIS) database. The prevalence per 100,000 persons of PD and dysphagia with PD from 2006 to 2015 was analyzed in the general population aged ≥ 40 years. Patients newly diagnosed with PD between 2010 and 2015 were compared with those without PD. RESULTS: The prevalence of PD and dysphagia in patients with PD increased continuously during the study period and was highest in the ninth decade of life. The percentage of patients with dysphagia in patients with PD increased with age. Patients with PD showed an adjusted hazard ratio of 3.132 (2.955-3.320) for dysphagia compared to those without PD. CONCLUSION: This nationwide study showed increasing trends in the prevalence of PD and dysphagia among patients with PD in Korea between 2006 and 2015. The risk of dysphagia was three times higher in patients with PD than that in those without PD, highlighting the importance of providing particular attention.
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Trastornos de Deglución , Enfermedad de Parkinson , Humanos , Enfermedad de Parkinson/complicaciones , Enfermedad de Parkinson/epidemiología , Enfermedad de Parkinson/diagnóstico , Trastornos de Deglución/etiología , Trastornos de Deglución/complicaciones , Modelos de Riesgos Proporcionales , Prevalencia , República de Corea/epidemiologíaRESUMEN
We propose a digital biomarker related to muscle strength and muscle endurance (DB/MS and DB/ME) for the diagnosis of muscle disorders based on a multi-layer perceptron (MLP) using stimulated muscle contraction. When muscle mass is reduced in patients with muscle-related diseases or disorders, measurement of DBs that are related to muscle strength and endurance is needed to suitably recover damaged muscles through rehabilitation training. Furthermore, it is difficult to measure DBs using traditional methods at home without an expert; moreover, the measuring equipment is expensive. Additionally, because traditional measurements depend on the subject's volition, we propose a DB measurement technique that is unaffected by the subject's volition. To achieve this, we employed an impact response signal (IRS) based on multi-frequency electrical stimulation (MFES) using an electromyography sensor. The feature vector was then extracted using the signal. Because the IRS is obtained from stimulated muscle contraction, which is caused by electrical stimulation, it provides biomedical information about the muscle. Finally, to estimate the strength and endurance of the muscle, the feature vector was passed through the DB estimation model learned through the MLP. To evaluate the performance of the DB measurement algorithm, we collected the MFES-based IRS database for 50 subjects and tested the model with quantitative evaluation methods using the reference for the DB. The reference was measured using torque equipment. The results were compared with the reference, indicating that it is possible to check for muscle disorders which cause decreased physical performance using the proposed algorithm.
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BACKGROUND: Assistive hand exoskeletons are promising tools to restore hand function after cervical spinal cord injury (SCI) but assessing their specific impact on bimanual hand and arm function is limited due to lack of reliable and valid clinical tests. Here, we introduce the Berlin Bimanual Test for Tetraplegia (BeBiTT) and demonstrate its psychometric properties and sensitivity to assistive hand exoskeleton-related improvements in bimanual task performance. METHODS: Fourteen study participants with subacute cervical SCI performed the BeBiTT unassisted (baseline). Thereafter, participants repeated the BeBiTT while wearing a brain/neural hand exoskeleton (B/NHE) (intervention). Online control of the B/NHE was established via a hybrid sensorimotor rhythm-based brain-computer interface (BCI) translating electroencephalographic (EEG) and electrooculographic (EOG) signals into open/close commands. For reliability assessment, BeBiTT scores were obtained by four independent observers. Besides internal consistency analysis, construct validity was assessed by correlating baseline BeBiTT scores with the Spinal Cord Independence Measure III (SCIM III) and Quadriplegia Index of Function (QIF). Sensitivity to differences in bimanual task performance was assessed with a bootstrapped paired t-test. RESULTS: The BeBiTT showed excellent interrater reliability (intraclass correlation coefficients > 0.9) and internal consistency (α = 0.91). Validity of the BeBiTT was evidenced by strong correlations between BeBiTT scores and SCIM III as well as QIF. Wearing a B/NHE (intervention) improved the BeBiTT score significantly (p < 0.05) with high effect size (d = 1.063), documenting high sensitivity to intervention-related differences in bimanual task performance. CONCLUSION: The BeBiTT is a reliable and valid test for evaluating bimanual task performance in persons with tetraplegia, suitable to assess the impact of assistive hand exoskeletons on bimanual function.
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Dispositivo Exoesqueleto , Traumatismos de la Médula Espinal , Humanos , Psicometría , Reproducibilidad de los Resultados , Berlin , Mano , Cuadriplejía/diagnóstico , Cuadriplejía/rehabilitación , Traumatismos de la Médula Espinal/rehabilitaciónRESUMEN
Background: Impaired movement after stroke is closely associated with altered brain functions, and thus the investigation on neural substrates of patients with stroke can pave a way for not only understanding the underlying mechanisms of neuropathological traits, but also providing an innovative solution for stroke rehabilitation. The objective of this study was to precisely investigate altered brain functions in terms of power spectral and brain network analyses. Methods: Altered brain function was investigated by using electroencephalography (EEG) measured while 34 patients with chronic stroke performed movement tasks with the affected and unaffected hands. The relationships between functional brain network indices and Fugl-Meyer Assessment (FMA) scores were also investigated. Results: A stronger low-beta event-related desynchronization was found in the contralesional hemisphere for both affected and unaffected movement tasks compared with that of the ipsilesional hemisphere. More efficient whole-brain networks (increased strength and clustering coefficient, and prolonged path length) in the low-beta frequency band were revealed when moving the unaffected hand compared with when moving the affected hand. In addition, the brain network indices of the contralesional hemisphere indicated higher efficiency and cost-effectiveness than those of the ipsilesional hemisphere in both the alpha and low-beta frequency bands. Moreover, the alpha network indices (strength, clustering coefficient, path length, and small-worldness) were significantly correlated with the FMA scores. Conclusions: Efficient functional brain network indices are associated with better motor outcomes in patients with stroke and could be useful biomarkers to monitor stroke recovery during rehabilitation.
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BACKGROUND: Botulinum toxin type A injection is widely used treatment option for the treatment of upper limb spasticity in stroke patients. The purpose of this study was to explore the safety and efficacy of MT10107, a new botulinum toxin type A, in patients with post-stroke upper limb spasticity. METHODS: A prospective, randomized, double-blind, active drug-controlled, multi-center, phase I clinical trial. Thirty patients with post-stroke upper limb spasticity were received either MT10107 or onabotulinumtoxinA. Primary endpoint was change of modified Ashworth scale (MAS) score for wrist flexor from baseline to week 4. The secondary endpoints were changes of MAS scores for elbow and finger flexors, response rate, Disability Assessment Scale (DAS), and global assessment of treatment. The safety endpoints such as adverse events, vital signs, physical examination, and laboratory test were evaluated. The outcome measures were evaluated from baseline to week 4. RESULTS: The primary endpoints were -1.07 ± 0.70 and -1.23 ± 0.56 for the MT10107 and onabotulinumtoxinA groups, respectively. The intergroup difference of change between the 2 groups was 0.17 (95% confidence interval -0.31 to 0.64, P = .5769). In secondary endpoints, both groups showed a significant improvement in both MAS and DAS. There was no significant between-group difference in all secondary endpoints and safety measures. CONCLUSION: The safety and efficacy of MT10107 showed no significant difference compared to onabotulinumtoxinA in post-stroke upper limb spasticity treatment.