Hauser Ambulation Index Research Articles

P.011 Efficacy and safety of ravulizumab in adults with AQP4+ NMOSD: interim analysis from the ongoing phase 3 CHAMPION-NMOSD trial

Background: CHAMPION-NMOSD (NCT04201262) is an ongoing global, open-label, phase 3 study evaluating ravulizumab in AQP4+ NMOSD. Methods: Adult patients received an intravenous, weight-based loading dose of ravulizumab on day 1 and a maintenance dose on day 15 and every 8 weeks thereafter. Following a primary treatment period (PTP; up to 2.5 years), patients could enter a long-term extension (LTE). Results: 58 patients completed the PTP; 56/2 entered/completed the LTE. As of June 16, 2023, median (range) follow-up was 138.4 (11.0-183.1) weeks for ravulizumab (n=58), with 153.9 patient-years. Across the PTP and LTE, no patients had an adjudicated on-trial relapse during ravulizumab treatment. 91.4% (53/58 patients) had stable or improved Hauser Ambulation Index score. 91.4% (53/58 patients) had no clinically important worsening in Expanded Disability Status Scale score. The incidence of treatment-emergent adverse events (TEAEs) and serious adverse events was 94.8% and 25.9%, respectively. Most TEAEs were mild to moderate in severity and unrelated to ravulizumab. TEAEs leading to withdrawal from ravulizumab occurred in 1 patient. Conclusions: Ravulizumab demonstrated long-term clinical benefit in the prevention of relapses in AQP4+ NMOSD with a safety profile consistent with prior analyses.

The use of an exoskeleton in the comprehensive rehabilitation of patients with impaired motor activity

Abstract. Purpose of the study: to evaluate the effectiveness of comprehensive rehabilitation of patients with impaired mobility using the E-Helper exoskeleton and a treadmill in a day hospital. Materials and methods. The study involved 42 patients with mobility impairments who underwent the third stage of medical rehabilitation in the day hospital at the Republican Medical and Physical Education Center, Ufa. The study participants were divided into two equal groups, comparable in terms of the main studied indicators. The patients in the control group (CG, n = 21) received a basic complex consisting of therapeutic exercises, mechanotherapy using the FISITEK 2000TS device, magnetic therapy from the ALIMP-1 device, and sessions with a psychologist. The patients of the study group (SG, n = 21) were additionally prescribed exercises on the exoskeleton and a treadmill for 30 minutes daily, 10 procedures per course. To analyze the effectiveness of rehabilitation, we used the modified Rankin scale and the Visual Analogue Scale (VAS) for pain intensity; to assess the patient»s locomotor function, the Hauser Ambulation Index and the EQ-5D quality of life questionnaire were utilized at the start of the study and at the end of the rehabilitation course (after 14 days). Results. It has been found that the use of an exoskeleton in the patients of the study group contributes to a more significant improvement in locomotor function, a decrease in functional dependence on external assistance, and an improvement in the quality of life of patients with impaired mobility compared to the control group.

The role of stroke-induced immunosuppression as a predictor of functional outcome in the neurorehabilitation setting

Stroke affects the interconnection between the nervous and immune systems, leading to a down-regulation of immunity called stroke-induced immunosuppression (SII). The primary aim of this study is to investigate SII role as a predictor of functional, neurological, and motor outcomes in the neurorehabilitation setting (NRB). We conducted a prospective observational study enrolling post-acute stroke patients hospitalized for neurorehabilitation. At NRB admission (T0) and discharge (T1), we assessed presence of SII (defined by a neutrophil-to-lymphocyte ratio ≥ 5) and we evaluated functional independence (Functional Independence Measure-FIM, Barthel Index-BI), motor performances (Tinetti Score, Hauser Ambulation Index) and neurological impairment (NIHSS). We enrolled 96 patients (45.8% females, 70.6 ± 13.9 years, 88.5% ischemic stroke). At T0, 15.6% of patients (15/96) had SII. When compared to immunocompetent patients (IC), the SII group was characterized by worse baseline functional independence, motor performances and neurological disability. The same was confirmed at T1 (FIM p = 0.012, BI p = 0.007, Tinetti p = 0.034, NIHSS p = 0.001). Neurological disability demonstrated a less pronounced improvement in SII (ΔNIHSS: SII: − 2.1 ± 2.3 vs. IC: − 3.1 ± 2.5, p = 0.035). SII group presented a higher percentage of infectious complications during the neurorehabilitation period (SII 80% vs. IC 25.9%; p = 0.001). SII may represent a negative prognostic factor in the neurorehabilitation setting. SII patients were characterized by poorer functional, motor, neurological performances and higher risk of infectious complications. ClinicaTrial registration: NCT05889169.

Dynamics of motor and functional disorders in the early recovery period after ischemic stroke

To study the dynamics and degrees of motor and functional disorders in patients with hemiparesis during the first 6 months after ischemic stroke under the impact of medical rehabilitation, including kinesiotherapy, physiotherapy and transcranial magnetic stimulation. Motor disorders and functional limitations were assessed using validated scales (Fugl-Meyer, Medical Research Committee Scale, Modified Ashworth Scale of muscle spasticity, Modified Frenchay scale, Wolf Motor Function Test, Action Research Arm Test, Rivermead mobility index, Hauser ambulation index, Functional Independence Measurement). Diagnostic and therapeutic transcranial magnetic stimulation was performed using the «Neuro-MS/D» magnetic stimulator. The dynamics of types and degrees of motor and functional disorders were evaluated in 113 patients with hemiparesis in the first 6 months after ischemic stroke. Severe disorders of the tone and strength characteristics of paretic muscles and limitation of movement in the joints of paretic extremities have been found in 2/3 of patients. The balance function (it is difficult to maintain a vertical position of the body) was impaired in 1/2 of patients. The correlations of electrophysiological indicators (diagnostic transcranial magnetic stimulation and surface electromyography) with clinical ones (degree of paresis, tone of paretic muscles, motor abilities and motor skills of the paretic hand, independence in daily living) have been determined. Positive impact of medical rehabilitation, including kinesiotherapy, physiotherapy and transcranial magnetic stimulation, on the strength of paretic muscles of the hand and leg, mobility of patients, walking function, activity of the paretic hand (transfer by the hands, manipulation of extremities' segments and objects) has been revealed. Electrophysiological investigation has shown that the functional activity of the paretic muscles increased. Severe motor and functional disorders, most pronounced in distal segments of the extremities (lack of movements in 14-26% of cases), are prevalent in the first six months after ischemic stroke in the carotid system. The regression of motor disorders leads to an enhancement of functional abilities (use of the paretic extremities for the realization of various motor actions) under the impact of rehabilitation.

Functional electrical stimulation for foot drop syndrome in patients with cerebral stroke

BACKGROUND: The deterioration of walking function as a result of acute cerebrovascular accident manifested by the foot drop syndrome, leading to difficulties in maintaining balance in the standing position and increased substitution strategies, is the most important limiting factor that affects autonomy and independence. The results of short time training with functional electrical stimulation in patients with cerebral stroke in the early and late recovery periods remain unknown.
 AIM: to study the functional and clinical results of a short course of functional electrical stimulation in patients with cerebral stroke and foot drop syndrome.
 MATERIALS AND METHODS: The study involved 20 patients with early and late hemispheric acute cerebrovascular accident who received a course of single-channel 30-minute functional electrical stimulation training of the m. tibialis anterior in conjunction with the main program of motor rehabilitation (60 minutes), consisting of 12 sessions. The biomechanics of walking at a random pace before and after training was investigated. Spatial and temporal parameters of walking, movements in hip, knee and ankle joints and maximum amplitudes of electromyography of the main muscle groups responsible for walking were recorded. Classical clinical scales were also used.
 RESULTS: No negative reaction to training with functional electrical stimulation was obtained. After treatment, there was a significant improvement in the following scales was observed: "Dynamic Gait Index", "Hauser Ambulation Index", "Timed Up and Go Test" test, muscle strength assessment, "Activity and Participation" domains. Spatial and temporal parameters demonstrate a complex syndrome characteristic of post-stroke walking. Walking speed and step cycle length increased significantly after training. The kinematics of movements in the hip and knee joints do not reveal significant dynamics. The difference from the control group of contralateral side indices in knee and hip joints, indicating bilateral functional involvement in the pathologic process, draws attention. Goniograms of the ankle joints of the paretic limb revealed the following parameters characteristic of the sagging foot: increase in the circumduction parameter on the paresis side, total amplitude of hip joint movements, knee joint flexion in the transfer period (Ka3), and ankle joint flexion amplitude in the transfer period (A3). Following functional electrical stimulation training, no changes were observed in these parameters.
 CONCLUSION: All clinical parameters have improved. Objective diagnostic results of the functional electrical stimulation training showed no significant effect on ankle joint function. Taking into account the limitations of this study, a follow-up study is planned.

Efficacy and safety of ravulizumab in adults with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder: outcomes from the phase 3 CHAMPION-NMOSD trial (S5.002)

Efficacy and safety of ravulizumab in adults with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder: outcomes from the phase 3 CHAMPION-NMOSD trial (S5.002)

Telitacicept following plasma exchange in the treatment of subjects with recurrent neuromyelitis optica spectrum disorders: A single‐center, single‐arm, open‐label study

IntroductionNeuromyelitis optica spectrum disorders (NMOSD), mainly mediated by B cells and AQP4 antibody, has a high rate of recurrence. Telitacicept is a novel drug specifically targeting the upstream signaling for the activation of B cell with its following production of autoimmune antibodies. Thus, it may be a promising approach. Our study preliminarily explored the potential safety and effectiveness of Telitacicept following plasma exchange in the treatment of recurrent NMOSD.MethodsThis was a single‐center, single‐arm, open‐label study enrolling eight patients with recurrent NMOSD in China. All patients received plasma exchange three times, followed by Telitacicept 240 mg every week for 46 times. The primary endpoint was the time of first recurrence after enrollment. Secondary end points included: changes in Expanded Disability Status Scale score, Optic Spinal Impairment Scale score, Hauser Ambulation Index, number of lesions on MRI, retinal nerve fiber layer thickness measured by optical coherence tomography, latency and amplitude of visual evoked potential, titer of AQP4 antibody, and immune parameters of blood. Safety was also assessed. The study was registered with Chictr.org.cn (ChiCTR1800019427).ResultsEight eligible patients were enrolled. Relapse occurred in two patients (25%) and five patients (63%) remained relapse free after 48 weeks of treatment. The time to first recurrence was prolonged and the number of recurrences was reduced (p < 0.001, power of test = 1). One patient withdrew from the study due to low neutrophil count. No serious adverse events occurred.ConclusionsIn this small, uncontrolled study, Telitacicept following plasma exchange has the potential to be a safe treatment for patients with recurrent NMOSD. It may prolong the recurrence interval and reduces the annual count of recurrences. A multicenter randomized controlled study with a larger sample is thus feasible and needed to further assess its safety and efficacy.

Functional and activity limitations in patients after a stroke

To assess the types and degree of functional limitations and activity limitations in patients after ischemic and hemorrhagic strokes in the early recovery period, taking into account the type of stroke and the affected vascular pool. 528 patients after a stroke were examined. Functional limitations and activity limitations were assessed in ICF categories, taking into account the type of stroke (hemorrhagic, ischemic) and the affected vascular system (carotid, vertebrobasilar), including dysfunctions (motor, global and specific mental functions, balance function, functions of the cardiovascular system), activity restrictions (limitations of paretic limbs mobility, functional independence from others). To quantify the degree of limitation, generally accepted rating scales were used (Medical Research Council Scale, Modified Ashworth Scale of muscle spasticity, Frenchay arm test, Hauser ambulation index, Rivermead mobility index, Functional Independence Measure, «Memory for images», «Learning 10 words», «Red-black Schulte-Platonov tables», Luscher color test, The hospital Anxiety and Depression Scale, Recovery Locus of Control), stabilography method, registration of office and outpatient blood pressure. Limitations of the functions of paretic limbs and activity associated with maintaining body position, walking, movement, transfer, manipulation of objects and self-care, dependence on others in everyday life were found in most patients after hemorrhagic stroke (in 94-95%) and ischemic (in 88-93%) stroke in the carotid pool, while more severe disorders were recorded in cases of hemorrhagic type of stroke. Violation of global mental functions was recorded in ¼ of patients, specific mental functions - in 60-75% of patients after hemorrhagic stroke and ischemic stroke in the carotid pool. In ischemic stroke happens in the vertebrobasilar basin, the limitations of the daily activity of patients were determined by the violation of static and dynamic balance; a mild degree of impairment of specific mental functions and limitation of activity (self-service) were also recorded. After a stroke, motor function disorders, mobility limitations of paretic limbs and self-service, postural disorders are recorded. After an ischemic stroke in the vertebrobasilar basin, the restrictions on the activity of patients are determined by postural disorders. Taking into account the identified features of functional limitations and activity limitations in patients after a stroke will allow developing a differentiated approach not only to the formation of goals and objectives of rehabilitation, but also to the choice of rehabilitation methods.

Early Initiation of Tocilizumab Treatment Against Moderate-to-Severe Myelitis in Neuromyelitis Optica Spectrum Disorder.

BackgroundInterleukin-6 receptor blockade is effective in reducing the risk of relapses in neuromyelitis optica spectrum disorder (NMOSD). However, its efficacy during acute attacks of NMOSD remains elusive.ObjectiveWe investigated the effects of tocilizumab on disability during acute attacks, as well as its maintenance, in patients with moderate-to-severe myelitis.MethodsNineteen patients with NMOSD received tocilizumab treatment as add-on to high-dose methylprednisolone (HDMP) in acute myelitis and twenty-two patients who only received HDMP were compared. Disease disability was assessed using a multi-level scaling system that included the expanded disability status scale (EDSS), Hauser ambulation index (HAI), modified Rankin scale (mRS), pain numerical rating scale (NRS), functional assessment of chronic illness therapy-fatigue scale (FACIT-F), activity of daily living (ADL), EuroQol five-dimensions-three-level questionnaire (EQ-5D-3L), and sensory function score and bowel and bladder function score in Kurtzke functional systems scores (FSS).ResultsImproved EDSS, HAI, and mRS, as well as increased ADL and EQ-5D-3L were significant in patients on tocilizumab compared with those on steroids as monotherapy at 3 months (p < 0.05). Both groups of patients showed improved pain, fatigue, sensory function, and autonomic function at follow-ups, compared with baseline respectively. The changes in NRS, FACIT-F, and sensory and autonomic FSS showed no significant differences between the two groups. Tocilizumab significantly lowered the risk of relapses (HR = 0.21, 95% CI 0.06–0.76, p = 0.017) and reduced the annualized relapse rate compared with those by steroids (0.1 ± 0.2 vs 0.5 ± 0.6, p = 0.013).ConclusionEarly initiation of tocilizumab provided a safe and effective add-on alternative during attacks, and its maintenance contributed to a significant reduction of relapse rate in NMOSD.

Telephone-based assessment of multiple sclerosis patients at Ain Shams University Hospital in the coronavirus disease 2019 pandemic

BackgroundAssessment of multiple sclerosis (MS) patients during the era of the coronavirus disease 2019 (COVID-19) pandemic was confronted with the overwhelmed healthcare facilities in Egypt and fear of the patients to get infected while attending the follow-up visits. This study aimed to assess the value of telephone-based assessments in the follow-up of MS patients. It includes one hundred and five patients who participated in the study and completed 3 telephone-based assessments which are the Hauser Ambulation index, Multiple Sclerosis Neuropsychology Questionnaire (MSNQ), and Symptoms of Multiple Sclerosis Scale (SMSS).ResultsThe Hauser Ambulation index was significantly correlated with the latest Expanded Disability Status Scale (EDSS) score done within 1 month from the telephone call (r=0.738, P<0.001). The analysis of MSNQ scores showed that one-third of the study population had evidence of cognitive and/or neuropsychological impairment. Post hoc analysis regarding the cognitive and psychological impairment component of SMSS revealed that the patients who answered “Never” had significantly lower MSNQ scores compared to those who answered “Sometimes” (P=0.016), “Often” (P=0.022), and “Always” (P=0.001). The comparison of the EDSS scores of the patients regarding the sensory-motor impairment component of SMSS showed a non-significant difference.ConclusionThe Hauser Ambulation index may be a reliable telephone-based tool for the assessment of physical disability. The MSNQ and the cognitive and psychological impairment component of SMSS can be used for the assessment of cognitive and psychological impairment among patients with MS.

Telitacicept Following Plasma Exchange in the Treatment of Subjects With Recurrent NMOSD: Study Protocol for a Single-Center, Single-Arm, Open-Label Study.

Background: Neuromyelitis optica spectrum disorder (NMOSD) is an autoimmune demyelinating disease that recurrently relapses and leads to severe disability. The available choices for disease prevention are few or intolerable. Previous studies suggested that telitacicept may provide a promising therapeutic strategy for autoimmune diseases involving B cells. Therefore, this study aims to assess the effectiveness and safety of telitacicept for recurrent NMOSD.Methods: We will perform a single-arm, single-center, open-label, specialist study with a total enrollment of eight participants. The treatment regimen includes plasma exchange three times and subcutaneous injection of telitacicept for 46 cycles, with a total period of 48 weeks. The primary endpoint is the time to first recurrence after enrollment. Secondary endpoints are Expanded Disability Status Scale (EDSS) score, Opticospinal Impairment Scale (OSIS) score, Hauser Ambulation Index, number of lesions on MRI, and changes in visual evoked potential (VEP), optical coherence tomography (OCT) and immunologic status. All adverse events after medication will be documented and investigated.Discussion: This study will explore the safety and effectiveness of telitacicept following plasma exchange regarding the time to recurrence in neuromyelitis optica spectrum disorder (NMOSD) for the first time.Clinical Trial Registration: Chictr.org.cn, identifier ChiCTR1800019427

Remote Rehabilitation of Patients with Impaired Motor Functions in Cerebral Pathology

Introduction. After passing the inpatient rehabilitation program, patients often experience a regression of the results achieved due to the low activity of outpatient rehabilitation. The solution to this problem is the introduction of remote rehabilitation programs. Purpose. To analyze the results of remote patients’ rehabilitation with impaired motor functions in cerebral stroke using Steps Reabil software. Material and methods. 32 patients with stroke were examined at the ISMA clinic. They were randomly assigned to a group of patients who continued a remote course of kinesotherapy using the Steps Reabil program for 3 months. (Steps Reabil group, n = 14) and to the group of people who received recommendations on therapeutic exercises for homework and were not appealing to this software (comparison group, n = 18). At the time of discharge, 1 and 3 months into, the capabilities were evaluated according to the Frenchay, «Stand up and go» tests, the Rivermead mobility index and Hauser Ambulation Index, the Berg Balance Scale, and the EuroQol-5D quality of life questionnaire. Results. When comparing the initial results in the study groups, a statistically significant difference was found between the indicators on the Berg Balance Scale (the indicators were lower in the Steps Rehabil group), but the differences were leveled out after 3 months. When comparing the results in the Steps Reabil group at discharge and after 3 months, there was an improvement as of the Berg Balance Scale, the Rivermead mobility index and the Hauser Ambulation Index, and the Frenchay arm test. In the comparison group, from the moment of discharge and 3 months into, the results on the Berg Balance Scale improved (p &lt;0.05). Conclusion. The functioning of patients who continued rehabilitation kinesiotherapeutic measures using modern information technologies continues to improve effectively in everyday life. Remote rehabilitation for 3 months is much more effective than short-term monthly, which indicates the need for continuous controlled rehabilitation measures. The Berg Balance Scale is especially sensitive in assessing the functional capabilities of patients.

Therapeutic effects of mirror therapy in patients after stroke

To evaluate the effect of mirror therapy on the regression of motor disorders in the paretic arm, functional and psychological disorders, the patient's functioning and quality of life, risk factors for recurrent stroke in the early recovery period of stroke. We examined 219 patients after stroke, including 154 patients after ischemic stroke (IS) and 65 patients after hemorrhagic stroke (HS) in the early recovery period (21 days to 6 months). All patients received a standard medical rehabilitation course including medications, physical rehabilitation, and physiotherapeutic treatment. Patients were divided into four groups depending on the stroke type and the medical rehabilitation course received: two study treatment groups (post-IS and post-HS groups), which consisted of patients receiving the standard medical rehabilitation course and mirror therapy, and two comparison groups (post-IS and post-HS), in which patients received only the standard medical rehabilitation course. All patients before and after the medical rehabilitation course were evaluated for neurological disorders (NIHSS, Ashworth scale of muscle spasticity, Medical Research Council (MRC) Scale and handgrip test), functional limitations (Frenchay Arm Test, Hauser Ambulation Index, Rivermead Mobility Index, Functional Independence Measure (FIM), ICF), mental status («Visual Memory» and «10 Word Memory» methods, Schulte-Platonoff tables, Lüscher color test, Hospital Anxiety and Depression Scale (HADS), Locus of Control Recovery Questionnaire), quality of life (EQ-5D), arterial hypertension (Arterial Hypertension in Adults. Clinical Guidelines, 2020). Addition of the mirror therapy to the standard course provided additional therapeutic effects: in patients with IS, the high tone of the paretic muscles of the arm significantly decreased (by 46%); the target blood pressure was achieved in 96% of patients; severe disorders of functional independence and depression regressed; significant changes of mental functions parameters (visual memory, shifting attention); improvement of activity and participation parameters (carrying in the hands, self-care, housekeeping). In patients with HS, the muscle strength of the paretic arm significantly increased (by 35%); the target blood pressure was achieved in all patients; improvement of mental functions (motivation, shifting attention, visual memory), activity and participation parameters (objects moving and manipulation, self-care), and decreased level of depression were observed. The addition of mirror therapy to the standard of care for patients after stroke resulted in regression of neurological deficit, motor disorders in the paretic arm, improvement of emotions and motivation, mitigation of recurrent stroke risk factors, as well as significant impact on the cognitive functions and enhancement of patients' capabilities of self-care.

Exoskeleton Walk Training in Paralyzed Individuals Benefits From Transcutaneous Lumbar Cord Tonic Electrical Stimulation.

In recent years, advanced technologies featuring wearable powered exoskeletons and neuromodulation of lumbosacral spinal networks have been developed to facilitate stepping and promote motor recovery in humans with paralysis. Here we studied a combined effect of spinal cord electrical stimulation (SCES) and exoskeleton walk training (EWT) during an intensive 2-week rehabilitative protocol in spinal cord injury individuals (n = 19, American Spinal Injury Association Impairment Scale (AIS) A-11, B-5, C-3). The purpose of this study was to evaluate the compatibility of methods and to explore the main effects of combined SCES and EWT. All participants had a chronic state of paralysis (1–11 years after trauma). In addition, in the control group (n = 16, AIS A-7, B-5, C-4), we performed EWT without SCES. For EWT, we used a powered exoskeleton (ExoAtlet), while stability was assisted by crutches, with automatic arrest of stepping if excessive torques were detected. SCES was applied to the level of the mid-lumbar cord over the Th12 vertebra at 1 or 3 pulses/s (4 individuals with severe spasticity were also stimulated in an anti-spastic mode 67 pulses/s). The vertical component of the ground reaction force was recorded using the F-Scan system at the onset and after training with SCES. EWT with SCES significantly increased the foot loading forces, could decrease their asymmetry and 8 out of 19 subjects improved their Hauser Ambulation Index. The anti-spastic mode of stimulation also allowed individuals with severe spasticity to walk with the aid of the exoskeleton. Participants reported facilitation when walking with SCES, paresthesia in leg muscles and new non-differential sensation of passive motion in leg joints. Neurological examination showed an increase of tactile (7) and/or pain (7) sensation and an increase of the AIS motor scale in 9 individuals, including both incomplete and complete paralysis. Improvements in the neurological scores were, however, limited in the control group (EWT without SCES). The results suggest that SCES may facilitate training and walking in the exoskeleton by activating the locomotor networks and augmenting compensative sensitivity.

Нейрометаболическая поддержка у пациентов с двигательными нарушениями при инсульте на втором этапе реабилитации

Study Objective: To evaluate dose-dependent effects of adjunctive treatment with ethylmethylhydroxypyridine succinate within a comprehensive course of rehabilitation, in cerebral stroke patients with movement disorders in the second stage of rehabilitation. Study Design: This was a randomized study. Materials and Methods: Forty ischemic stroke patients were examined, and divided into three groups. Ethylmethylhydroxypyridine succinate was given intramuscularly to 18 patients: 250 mg/day (5 mL) in Group 1 (n = 9) and 100 mg/day (2 mL) in Group 2 (n = 9). In Group 3 (n = 22) patients did not receive this drug. All patients underwent a complete examination, including assessment of the following parameters: static and dynamic balance, as assessed by the Standing Balance Test and the Berg Balance Test; walking (Hauser Ambulation Index); and emotional (Hospital Anxiety and Depression Scale), cognitive (Montreal Cognitive Assessment), and sensory (Fugl-Meyer Assessment Scale) functions. Patients’ balance status was objectively assessed using stabilometric parameters. Study Results: Group 1 patients showed a significant increase in Berg Balance Test scores (from 44.00 [42.00; 47.00] to 46.00 [42.00; 49.00]) and a decrease in statokinesigram area (with eyes closed) (from 910.92 [36.20; 2,633.50] mm2 to 620.98 [213.40; 1,676.30] mm2 (p &lt; 0.05). All groups exhibited trends toward improvement of static balance, quality of walking, and cognitive and sensory functions, but only the changes in the Montreal Cognitive Assessment in Group 1 were statistically significant (from 24.67 [19; 27] to 26.67 [22; 29]). Conclusion: Adjunctive ethylmethylhydroxypyridine succinate, 5 mL (250 mg/day), within a course of rehabilitation improved patients’ balance status and cognitive functions. Patients who received this medication at a dose of 2 mL (100 mg/day) and those who did not receive it showed no significant improvement during rehabilitation. Keywords: stroke, balance, neurometabolic therapy, ethylmethylhydroxypyridine succinate.

Fluoxetine in progressive multiple sclerosis: The FLUOX-PMS trial

Background: Preclinical studies suggest that fluoxetine has neuroprotective properties that might reduce axonal degeneration in multiple sclerosis (MS). Objective: To determine whether fluoxetine slows accumulation of disability in progressive MS. Methods: In a double-blind multicenter phase 2 trial, patients with primary or secondary progressive MS were randomized to fluoxetine 40 mg/day or placebo for a period of 108 weeks. Clinical assessments were performed every 12 weeks by trained study nurses who visited the patients at their home. The primary outcome was the time to a 12-week confirmed 20% increase in the Timed 25 Foot Walk or 9-Hole Peg test. Secondary outcomes included the Hauser ambulation index, cognitive tests, fatigue, and brain magnetic resonance imaging (MRI). Results: In the efficacy analysis, 69 patients received fluoxetine and 68 patients received placebo. Using the log-rank test (p = 0.258) and Cox regression analysis (p = 0.253), we found no significant difference in the primary outcome between the two groups. Due to an unexpected slow rate of progression in the placebo group, there was insufficient statistical power to detect a potential benefit of fluoxetine. We found no differences between the two groups for secondary outcomes. Conclusion: The trial failed to demonstrate a neuroprotective effect of fluoxetine in patients with progressive MS.

New Predictive Index for Survival in Symptomatic Spinal Metastases

Patients with spinal metastases have broad variability in morbidity, mortality, and survival. Existing prognostic scoring systems have limited predictive value. Our aim is, given recent advances in surgical and medical care for patients with cancer and spinal metastases, to develop a new survival index with superior prognostic value. We completed a retrospective analysis on 77 patients who received surgery for metastatic tumors to the spine, of patient factors like pathologic subtype, age, neurologic examination, type of surgical procedure, Hauser Ambulation Index, and a novel scoring system for degree of tumor burden in several organ systems, among others. A survival index will be derived from the patient factors that, when measured preintervention, best predicted survival post intervention. Although primary organ or pathologic type was not predictive of survival for patients with metastatic disease in this population, the degree of lung tumor burden (LTB) and preoperative Hauser Ambulation Index were predictive of survival. After a multivariable analysis of >20 different patient factors, the Jenkins Survival Index (JSI, a 0-21 scale) was constructed using a machine-learning system as the sum of the HAI (0-9 scale) and LTB score (0-3 scale) multiplied by 4 (JSI= HAI+ 4 · LTB, Rho=-0.588, P < 0.0001). The JSI had a positive predictive value of 92% compared with 54.1% and 56.9% for Tokuhashi and Tomita scales, respectively. The JSI predicts in a meaningful way survival outcomes for patients symptomatic from spinal metastases, which will be of value to oncologists and other clinicians treating patients with metastatic disease.

A research on efficacy of rehabilitation for post-stroke patients in Krasnoyarsk region performed upon the programme of the ministry of health of Russia in 2016

Krasnoyarsk Region is among the largest regions of Russia. Its population amounted 2,875,790 by January 1, 2017. A three-stage rehabilitation system for patients after stroke has been created in the region. Over 6000 patients received successive rehabilitation in 2016. The purpose of the research was to assess efficacy of complex successive post-stroke rehabilitation in Krasnoyarsk Region in 2016. A total of 163 patients after stroke (12 months), were enrolled into the unblinded study among which were 103 male and 60 female patients. The age varied from 32 to 91 years (57 ± 12.4). Ischaemic stroke was revealed in 144 patients while haemorrhagic stroke was revealed in 18. The study was conducted in the regional vascular centre at Stage I, in the Centre of neurorehabilitation of the FSSRCC of FMBA of Russia at Stage II and in the clinic of Krasnoyarsk Medical University at Stage III. Glasgow Coma Scale (Stage I only), modified ranking scale, NISSH, Ashworth spasticity, pain, dysarthria assessment scales, Wasserman test, MASA, HADS, MOCA, Rivermead Mobility Index, BBS, Hauser Ambulation Index, Frenchay Arm Test, FIM, EQ-5D were used. Statistical analysis was performed using non-parametric Wilcoxon and Mann-Whitney criteria. The patients were divided into 3 groups after examination: group I ( n = 39) included patients after only rehabilitation stage I. Group II ( n = 61) included patients after stages I and II, and group III ( n = 63) included patients after all stages. It has been found that best statistically significant results according to clinical scales were found in group III patients as manifested by disablement and neurological deficit decrease and motion activity value enhancement. In Krasnoyarsk region, the best efficacy has been shown by the complex successive rehabilitation for patients after stroke performed in stages.

Botulinum toxin in treatment of lower limb spasticity in patients with brain damage

To develop and test a method of examination of patients with lower limb spasticity, to describe lower limb spasticity patterns in patients with brain damage and to assess the efficacy of abobotulinumtoxin A (dysport) in the rehabilitation of patients with stroke. Spasticity rating scales (MAS and Tardieu), the Barthel index, the Rankin scale , the Rivermead Mobility Index, the Hauser Ambulation Index, a comfortable walking test were used. Treatment satisfaction was assessed with the Visual analogue scale. Abobotulinumtoxin A (dysport) was used for treatment of lower limb spasticity. Two most common patterns (dynamic and static) were identified in patients with post-stroke spasticity and the method of testing spasticity was developed. The prevalence of spasticity in individual muscles of the lower extremity was estimated as well. An analysis of the efficacy of dysport and a sensitive analysis of the scales used in the study were carried out.

Umbilical cord-derived mesenchymal stem cell therapy for neurological disorders via inhibition of mitogen-activated protein kinase pathway-mediated apoptosis.

The present study investigated the recovery and intrathecal administration of human umbilical cord‑derived mesenchymal stem cells (HUC‑MSCs) by lumbar puncture and analyzed the technical difficulties and short and long‑term effects of UC‑MSC transplantation in various neurological conditions. In total, 100 patients who underwent subarachnoid placement of UC‑MSCs between December 2006 and May 2010 were included in the present study. The present study evaluated the number of attempts, localization of subarachnoid space and postprocedural complications. The Hauser Ambulation Index was employed for functional assessment. Clinical symptoms, the associated biochemical index and photographic examinations were observed regularly. HUC‑MSCs were transplanted into mice as well as patients in order to determine the underlying therapeutic mechanisms. Technical difficulties were encountered in 31 patients (31%) in the form of general anesthesia supplementation and difficulty localizing lumbar space. Side effects were observed in 22 (22%) patients, which resolved with symptomatic treatment within 48 h. On follow‑up one year later, functional indices improved in 47 (47%) patients. Transplantation of HUC‑MSCs inhibited apoptosis and the protein expression of c-Jun N-terminal kinase and p38 as well as triggered the phosphorylation of P‑42/44 extracellular-signal-regulated kinase. In conclusion, intrathecal administration of UC‑MSCs is safe and effective with no long‑term adverse effects in neurological disorders. HUC‑MSCs may achieve these effects via the mitogen‑activated protein kinase pathway. The results suggest that there is a promise of restoration of lost tissue and improvement of function in patients with profound neurological defects. These data support expanded double blind, placebo‑controlled studies for this treatment modality.