30 resultados para Ensayo clínico


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Canine Visceral Leishmania (CVL) is an important zoonotic disease that has a world wide distribution and has a large impact on public health on the American Continent, especially in Brazil, where the nature of endemic diseases in humans affects a large part of the nation. The influence of the prevalence of CVL in the increased rate of human cases in endemic areas and in the unleashing of epidemic outbreaks shows the need for a more profound understanding, that would generate significant advances in the current measures used to control the reservoirs of sickness that are practiced by the Programa Nacional de Vigilância e Controle da Leishmaniose Visceral. The present work describes and compares the clinical-laboratorial and histopathological findings of twenty-three dogs that were naturally infected by Leishmania chagasi, from endemic areas in metropolitan Natal, Rio Grande do Norte, Brazil. These animals, that were selected and given physical and serological exams (IFI and ELISA rK-39), were classified according to the degree of clinical severity and had blood samples drawn (whole blood and serum) for a complete hemogram and a coagulogram to be done as well as biochemical tests for kidney and liver function. The confirmation of infection by L. chagasi was done after the euthanasia of the animals, through the direct demonstration of the parasite in the impression of the spleen and liver crowned with GIEMSA and through a cultivation by means of NNN/Schneider. According to the clinical evaluation, the animals were classified as asymptomatic (7), oligosymptomatic (7) and polysymptomatic (9). Among the animals that were chosen to be autopsied, there were 2 asymptomatic, 3 oligosymptomatic and 3 polysymptomatic, for the purpose of studying their histopathology, having collected fragments of the spleen, liver, kidneys and skin and were fixed in 10% tamponed formol. The comparison between the average parameters of the clinical-laboratory tested animals in the groups was done through the Student t test (a<0.05). The main clinical signals observed were lymphadenomegaly, alopecy, dermatitis, exfoliation, cutaneous ulcers, onicogriphosis and emaciation. The main clinical-laboratorial alterations established, mainly in the polysymptomatic group, were anemia, hyperproteinemia, hyperglobulinemia, alterations in the albumin/globulin ratio and increased ALT activity. Renal alterations were not verified (urea and creatinine levels were normal). Thrombocytopenia was observed in three clinical groups. However, the other indicators of coagulation function (TAP and TTPA) did not have abnormal variations. There were inflammatory infiltrations and leishmania amastigotes in the skin of polysymptomatic dogs, however, they were not found in the skin of asymptomatic animals. Hypertrophy and hyperplasia of the phagocyte mononuclear system, leishmania amastigote parasites were found in the macrophages, extramedullary hematopoiesis and degenerative alterations were detected in the spleen and liver of 8 of the animals submitted to histopathological exams. In accord with these results, it was demonstrated that the expected alterations in the hematological and biochemical parameters in function of their viscerotropic nature of CVL are mainly observed in the more advanced stages of the disease. The absence of inflammatory infiltration and parasite load in the skin suggest that infected animals without symptoms may have an importance irrelevant to the infectiousness of the vector

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Fibromyalgia (FM) is a chronic rheumatic syndrome characterized by diffuse muscle-skeletal pain, and aerobic exercises represent a fundamental portion in therapeutic approach. Objective of this study was to evaluate the effectiveness of aerobic exercises accomplished in the water of the sea (thalassotherapy) for women with FM and to compare with exercises accomplished in the swimming pool, involving a multidisciplinary team, composed by rheumatologists, physical therapists, students of physical therapy and students of physical education. Forty six (46) women with age between 18 and 60 years with FM were randomized in 2 groups: a swimming pool group (23 patients) and a sea group (23 patients). 80th groups trained a week with the same program of aerobic conditioning 3 times (60 minutes each) for 12 weeks. Ali the patients were evaluated, before and immediately after treatment, with Visual Analogical Scale (VAS) for pain and fatigue, number of tending points, Fibromyalgia Impact Ouestionnaire (FIO), Short Form 36 Health Survey (SF-36), Pittsburgh Sleep Ouality Index (PSOI) and Beck Oepression Inventory (BOI). For statistical analysis, it was used paired-t test for analysis intra-group and non-paired test for inter-groups analysis, significance levei of p <0,05. Four patients, of each group, didn't complete the training programo Groups were homogeneous and they were compared in initial evaluation, except for BOI (p <0,05). Both groups presented statistically significant improvement for ali appraised parameters in the post-treatment compared with initial evaluation, there were reduction of intensity of pain and fatigue, number of tending points, better functional capacity (FIO), life quality (SF-36), quality of sleep (PSQI) and depression indexes (BOI). However, in comparison among the groups, group of sea (thalassotherapy) presented better results for ali parameters, however with statistically significant difference just only for depression indexes (BOI). At the end, it was observed that accomplishment of aerobic exercises in sea water or swimming pool was effective as part of treatment for patients with FM. However, exercise programs with thalassotherapy seems to bring more benefits, mainly related to emotional aspects, could be a therapeutic option of low cost for patients with FM in our area

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

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Introdução: A criação de programas de equipe multiprofissional de saúde desponta como uma alternativa eficiente para controlar a evolução dos pacientes portadores de diabetes, e a inserção do farmacêutico em tais programas tem contribuído para melhorar o acompanhamento desses pacientes. Objetivo: Avaliar o impacto da intervenção do farmacêutico no acompanhamento dos pacientes diabéticos tipo 2, em farmácias comunitárias. Métodos: Ensaio clínico randomizado, uni-cego envolvendo 100 pacientes diabéticos tipo 2 de ambos os gêneros, usuários de farmácia comunitária, com idade igual ou superior a 30 anos, em uso de hipoglicemiantes orais com adição ou não de insulina e foram acompanhados por 6 meses. Os pacientes do grupo controle receberam o tratamento habitual existente em qualquer farmácia, e os de intervenção receberam o acompanhamento do farmacêutico incluindo intervenções aos problemas relacionados aos medicamentos. Os desfechos primários avaliados foram os valores da hemoglobina glicada (HbA1c), glicose basal e um questionário de qualidade de vida validado denominado de Diabetes Quality of Life Measure (DQOL) - Brasil; e como desfechos secundários as dosagens dos triglicérides, colesterol total, (HDL) colesterol, (LDL) colesterol, tensão arterial e a satisfação do usuário com o serviço prestado. Essa pesquisa contou com a colaboração de vários profissionais das diferentes áreas do conhecimento a seguir nominados: médico, farmacêutico bioquímico, enfermeiro, nutricionista e estatístico. Resultados: Finalizaram o estudo 89 pacientes. Durante o acompanhamento 95,7% (45/47) dos pacientes no grupo intervenção apresentaram problemas relacionados aos medicamentos (PRM), perfazendo um total de 141, com uma média de 3 eventos por paciente, ocorrendo uma resolutividade de 61,7% (87/141). A categoria que mais apresentou PRM foi a de efetividade com 34,1% (48/141) e a classe farmacológica mais utilizada foi a dos hipoglicemiantes orais com 35% (49/141). As variáveis de desfechos primários como hemoglobina glicada (HbA1c) e a glicose basal não apresentaram valores estatisticamente significantes quando comparadas o final com o inicial do acompanhamento nos grupos intervenção e controle considerando um p<0,05, mas o questionário de qualidade de vida DQOL Brasil apresentou resultados estatisticamente significante com um p=0,000. Os desfechos secundários, com exceção da satisfação do usuário, não apresentaram valores xi estatisticamente significantes quando comparados o final com o início do acompanhamento nos grupos de intervenção e controle. Conclusão: Os resultados indicam que as modificações das variáveis clínicas não apresentaram valores significativos no controle da enfermidade e comorbidades, enquanto que na avaliação da qualidade de vida os pacientes afirmaram que melhoraram; portanto, pode-se postular que a intervenção farmacêutica é uma atividade necessária, mas que a prática do Pharmaceutical Care trará benefícios com sustentabilidade para os pacientes se houver uma efetiva integração do farmacêutico numa equipe multiprofissional de saúde, o que está indisponível nas Farmácias Comunitárias

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A analgesia pós-operatória eficaz é especialmente importante após cirurgias torácicas, pois, além de aliviar a dor, facilita a retomada de atividades normais, incluindo a deambulação, a respiração e a tosse. Dessa forma, os objetivos deste estudo são: avaliar a eficácia analgésica da associação entre anestesia geral e raquianestesia com morfina e ropivacaína mais esquema multimodal em relação à anestesia geral e esquema multimodal em cirurgia de revascularização do miocárdio; analisar a eficácia analgésica da injeção subcutânea de lidocaína e analgesia multimodal na remoção de tubos torácicos em cirurgia de revascularização do miocárdio. A metodologia consiste em ensaio clínico randomizado, controlado, envolvendo 58 pacientes, de ambos os sexos, com idade média de 59,8  8,9 anos, estado físico ASA II e III. Os participantes foram alocados em dois grupos, sendo o GI composto por indivíduos submetidos à anestesia geral combinada à raquianestesia com morfina 400μg e 6 ml (30mg) a 8 ml (40mg) de ropivacaína a 0,5% e analgesia multimodal; já o GII foi composto por indivíduos submetidos à anestesia geral associada à analgesia multimodal. Foi avaliada a dor, ao despertar, nas primeiras 24 horas, e ao realizar exercício respiratório, ao retirar drenos de torácicos e o tempo para extubação. A análise estatística foi realizada pelos testes do Qui-quadrado e Teste t de Student e o teste de Fisher. O resultado obtido foi o seguinte: o GI apresentou menor intensidade de dor ao despertar (p= 0,001), nas primeiras 24 horas (p= 0,001) e durante a realização dos exercícios respiratórios (p= 0,004). Houve maior necessidade de analgesia complementar no grupo GII, com maior consumo de morfina (p= 0,05), e os efeitos colaterais leves, como náuseas (p= 0,001), vômito (p= 0,002), prurido (p= 0,030), predominaram no GI. Não houve diferença estatisticamente significante entre os grupos (P= 0,47), em relação à intensidade de dor na remoção dos drenos. Após as observações feitas, o estudo sugere que a anestesia geral combinada à raquianestesia com morfina associada à ropivacaína oferece melhor efeito analgésico no pós-operatório de cirurgia cardíaca. Adicionalmente, o estudo sugere que o efeito analgésico da injeção subcutânea de lidocaína 1% associado à analgesia multimodal não é eficaz

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As mucopolissacaridoses (MPS) são doenças genéticas raras decorrente da deficiência de enzimas lisossomais envolvidas no catabolismo de glicosaminoglicanos, resultando em um amplo espectro de manifestações clínicas, progressivas e multissistêmicas, exigindo tratamento por uma equipe multidisciplinar. Embora o Nordeste brasileiro seja uma região com grande taxa de consangüinidade e um efeito fundador envolvendo MPS, não há estudos caracterizando os pacientes dessa região. Nosso objetivo foi determinar o perfil epidemiológico, clínico e genético de casos não publicados com MPS provenientes do Ceará, identificando as diferenças entre outros estudos com MPS e possíveis problemas a serem enfrentados para a realização do diagnóstico precoce. O estudo foi seccional, descritivo, com amostra de pacientes com MPS em acompanhamento no Hospital Infantil Albert Sabin e Hospital Geral Cesar Cals no período de 2006-2013. Os dados foram obtidos a partir da avaliação clínica, revisão de prontuários médicos e entrevista com os pacientes e/ou familiares realizadas pelo investigador principal. Cinquenta e três pacientes foram incluídos no estudo (36 do sexo masculino), sendo 6 MPS I, 17 MPS II, 7 MPS III (3 MPSIII-A, 3 MPS III-B, 1 MPS III-C), 7 MPS IV-A, 16 de MPS VI. O óbito ocorreu em 16 casos (3 MPS I, MPS II 6, 1 MPS IIIA , IIIB 1MPS , 1 MPS IV , 4 MPS VI). A amostra foi composta principalmente por crianças. Houve elevada taxa de consangüinidade e recorrência familiar. Os tipos mais comuns foram MPS II e MPS VI. Exceto para macrossomia em MPS II, os dados de nascimento indicam que não houve risco para desenvolvimento de viii complicações perinatais. Os sintomas iniciaram em crianças com menos de 2 anos. As manifestações clínicas foram heterogêneas exceto para atraso no desenvolvimento neurológico em MPS III e manifestações esqueléticas em MPS IV. As principais características clínicas foram macrocefalia, baixa estatura, alterações odontológicas, respiratórias, cardíacas, hepatoesplenomegalia, hérnia umbilical, rigidez articular e anormalidades esqueléticas. A terapia de reposição enzimática foi instituída em 26 casos (4 MPS I, 10 MPS II, 12 MPS VI). Os problemas sócio-econômicos das famílias, o amplo espectro de sintomas e a gravidade da doença foram causas das dificuldades em realizar a avaliação periódica pela equipe multidisciplinar, além de exames complementares de maior custo para determinar as complicações da doença. Este foi o maior estudo transversal sobre MPS no Nordeste do Brasil. Em contraste com a maior incidência de MPS I na maioria das populações ocidentais, houve maior incidência de MPS II e VI. As alterações respiratórias foram um dos principais contribuintes para a mortalidade precoce, exceto nos casos de MPS I, em que a cardiomiopatia foi prevalente. A menor expectativa de vida ocorreu em MPS I. O envolvimento cognitivo foi comum em casos graves e o maior número de órgãos envolvidos representou maior risco de morrer. Para o diagnóstico precoce, deve-se buscar indivíduos afetados em famílias em que há parentes com MPS, além do maior reconhecimento de sinais e sintomas de MPS por profissionais de saúde

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

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PURPOSE: To evaluate the capacity of clofazimine (CFZ) to control cutaneous activity of systemic lupus erythematosus (SLE), compared with chloroquine diphosphate (CDP). METHODS: A prospective, randomized, controlled, double blind clinical trial was carried out in thirty-three patients with SLE and cutaneous lesions (malar rash and/or discoid lupus and/or subacute cutaneous lupus), after approval by the respective Ethics Committee. Sixteen patients received clofazimine - 100mg/day (CFZ group) and 17 received chloroquine diphosphate - 250mg/day (CDP group), during six months. Both groups applied broad-spectrum sunscreens twice a day. The dose of prednisone was kept stable during the study. Cutaneous lesions were evaluated by 2 blinded observers and photographed at baseline and at months 1, 2, 4 and 6. RESULTS: Thirty-three patients began and 27 completed the 6 months of treatment. The groups were homogeneous and comparable in terms of demographic and clinical characteristics. Five CFZ-patients and one CDP-patients dropped out due to severe flare of disease requiring other treatment. At the end of the study, 12 CFZ-patients (75%) and 14 CDP-patients (82,4%) presented complete or near-complete remission of skin lesions; intention-to-treat analysis showed no significant difference in the response rates between groups. Side effects in both groups were frequent, but patients didn t have to discontinue the drugs. CONCLUSIONS: Clofazimine and chloroquine were effective in controlling cutaneous lesions in SLE patients

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Este trabalho tem como objetivo o desenvolvimento de interfaces com o usuário para aplicativo móvel smartphones com intuito de contribuir para a eficiência das atividades de profissionais e pesquisadores da área de fisioterapia ao oferecer suporte ao acompanhamento clínico da dor no tratamento de pacientes fibromiálgicos. Utilizando a abordagem de Design Centrado no Usuário - DCU, foram realizadas entrevistas e uma investigação contextual para a identificação inicial dos problemas e necessidades dos usuários. Verificou-se que as atividades de monitoramento e acompanhamento das sessões do tratamento de pacientes fibromiálgicos são, tradicionalmente, realizadas por meio de manipulando de formulários e fichas em papel (registro das condições de saúde do paciente) e escalas de classificação da dor em formato impresso (apresentadas ao paciente para indicação de sua dor percebida para cada ponto pré-determinado do corpo). Os procedimentos envolvidos nestas atividades dificultam o gerenciamento do desempenho do tratamento, o que, segundo relatos, reflete no comprometimento dos pacientes na adesão e frequência as sessões. A partir da observação e do levantamento das necessidades desses profissionais diante de suas atividades, foi proposto um aplicativo para smartphone com a intenção de minimizar os problemas ocasionados pelo uso das ferramentas convencionais e de prover informações rápidas acerca dos dados coletados. Então, seguindo a abordagem do DCU foi elaborado um modelo conceitual durante a etapa de concepção de soluções, o qual guiou a criação dos protótipos. A avaliação das interfaces do protótipo foi realizada com o envolvimento dos usuários a partir da técnica de avaliação cooperativa. Seus resultados proporcionaram o refinamento das interfaces e o desenvolvimento de uma nova proposta do design das interfaces em protótipo de alta fidelidade, produzido para o ambiente Android. Assim, esse trabalho faz parte do processo de desenvolvimento de um produto de software personalizado com foco na concepção e avaliação das interfaces com o usuário. Por meio da metodologia aplicada, observaram-se indícios os quais sugerem que as interfaces propostas apresentaram-se como um recurso facilitador e capaz de contribuir para eficiência das atividades no acompanhamento do tratamento de pacientes fibromiálgicos

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To evaluate the effects of warm-up and stretching, singly or combined, on isokinetic performance and electromyographic activity of the biceps femoris. Materials and methods: Sixty-four volunteers of both sexes, with mean age of 23,1 ± 3,5 years and mean body mass index of 23,5 ± 2,5 Kg/m2 were randomly assigned into 4 groups: control, warm-up (stationary bicycle for 10 minutes), stretching (4 sets of 30 seconds of hamstring muscles static stretching) and warm-up + stretching. All the volunteers were submitted to evaluation pre and post-intervention of the muscle latency time and biceps femoris RMS and the passive torque, peak torque and power of the hamstring muscles. Results: The warm-up + stretching group had reduction of muscle latency time. There was a reduction of RMS during passive torque evaluation in stretching group. The RMS during isometric evaluation was reduced in all experimental groups. The RMS during eccentric evaluation showed reduction in control and warm-up + stretching groups. The passive torque and the eccentric peak torque had no significant differences pre to post-intervention in any group. There was reduction in isometric peak torque in all groups. Conclusion: The warm-up and stretching, when applied in combination can reduce the muscle latency time; stretching protocol promoted neural changes; the protocols used did not alter the muscle viscoelastic properties

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BACKGROUND: Treadmill training with partial body weight support (BWS) has shown many benefits for patients after a stroke. But their findings are not well known when combined with biofeedback. OBJETIVE: The purpose of this study was to evaluate the immediate effects of biofeedback, visual and auditory, combined with treadmill training with BWS on on walking functions of hemiplegic subjects. METHODS: We conducted a clinical trial, randomized controlled trial with 30 subjects in the chronic stage of stroke, underwent treadmill training with BWS (control), combined with visual biofeedback, given by the monitor of the treadmill through the symbolic appearance of feet as the subject gave the step; or auditory biofeedback, using a metronome with a frequency of 115% of the cadence of the individual. The subjects were evaluated by kinematics, and the data obtained by the Motion Analysis System Qualisys. To assess differences between groups and within each group after training was applied to ANOVA 3 x 2 repeated measures. RESULTS: There were no statistical differences between groups in any variable spatio-temporal and angular motion, but within each group there was an increase in walking speed and stride length after the training. The group of visual biofeedback increased the stance period and reduced the swing period and reason of symmetry, and the group auditory biofeedback reduced the double stance period. The range of motion of the knee and ankle and the plantar flexion increased in the visual biofeedback group. CONCLUSION: There are no differences between the immediate effects of gait training on a treadmill with BWS performed with and without visual or auditory biofeedback. However, the visual biofeedback can promote changes in a larger number of variables spatiotemporal and angular gait

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Objective:To analyze the immediate effects of the Kinesio Taping® application on the quadriceps neuromuscular performance, postural balance and lower limb function in healthy subjects. Materials andmethods:This is a randomized, controlled, blinded clinical trial. Sixtyfemale volunteers(age: 23.3±2.5 years old, BMI: 22.2±2.1kg/m2)wererandomly assigned intothreegroups with20memberseach,and performedone of these threeprotocols: control -10 minutesof rest,experimental 1- patch application ontherectusfemoris (RF), vastuslateralis(VL) and vastusmedialis(VM) and experimental 2-KT application on the same muscles. Allunderwent an evaluationfor singleand triple hop distance, postural balance (baropodometry), joint position sense(JPS), peak torque (concentric and eccentricevaluation at 60°/s)and electromyographic activityof VL,before andafter intervention.Results: There wasasignificant increasein the jump distanceof thethreestudied groups,with no differencebetween groups.There were nosignificant changesin postural balance,JPS, concentricpeak torqueand RMSof the VLin none of the groups. There was a reduction ineccentricpeak torquein all groups, without differencesbetween groups.Conclusion:The KT application on the RF, VL and VMmusclesis not able tosignificantly improvelower limbfunction and postural balance, as well as the kneeextensor peaktorque, JPSand the VL muscleactivation amplitudeof healthy women.

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Objective: To evaluate the effect of different resting periods, after induced muscle fatigue, in the quadriceps femoris neuromuscular performance, in healthy subjects. Methods: Sixty-four volunteers, of both genders, with an average of 21,8 ± 1,7 years and mean body mass index of 24,2 ± 3,7 Kg/m2 were randomly assigned into 4 groups: control group (was not induced fatigue); Experimental Group 1 (Exp. 1 1 minute of rest after fatigue); Experimental Group 3 (Exp. 3 3 minutes of rest after fatigue) and Experimental Group 5 (Exp. 5 5 minutes of rest after fatigue). The subjects were evaluated to the knee´s joint position sense (JPS), followed by 5 flexion-extension knee concentric isokinetic contractions at 60°/s, with concomitant recording of median frequency (Fmed) of rectus femoris (RF), vastus lateralis (VL) and vastus medialis (VM). Then they underwent a muscle fatigue protocol (30 flexion-extension knee concentric contractions at 60°/s) and were reevaluated on the isokinetic performance, Fmed and JPS. Blood lactate levels were measured before initial assessment, immediately after the fatigue protocol and 5 minutes after the end of the rest period. Results: The adoption of 3 minutes of rest was sufficient to restore the initial conditions for the peak torque normalized by body weight and the VL and VM Fmed. The joint position sense returned to its initial values with 1 minute rest. The lactate concentration remained high regardless of the adopted rest period. Conclusion: The use of 3-minute rest period is sufficient for the reestablishment of the neuromuscular parameters to the pre fatigue values.

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Among the therapeutic approaches that can be used to achieve this goal is the gait training on sloping surfaces, but there are few scientific findings that elucidate the results of this practice. OBJECTIVE: To evaluate the effects of training on sloping surfaces on the gait of subjects with chronic hemiparesis. MATERIALS AND METHODS: A controlled, randomized, blinded clinical trial was conducted. Concluded the study twenty-four subjects with age between 40 and 70 years (54,91±9,3). Their neurological function, functional independence, motor function and balance assessed, besides the gait evaluation through kinemetry. The subjects were allocated into two groups: control group (CG) underwent gait training on treadmill with partial body weight support (PBWS) without inclination; and the experimental group (EG) submitted to gait training on treadmill with PBWS and inclination of 10%. Twelve training sessions were performed. The paired t Student test and Wilcoxon test were used in statistical analysis to compare findings before and after training for each group, and the t student test for independent samples and Mann-Whitney.test were used to compare the to groups. RESULTS: After training within-group changes were observed on balance recovery, motor function and functionality, in both experimental conditions. The EG showed changes after training on speed, stride length, step length of paretic and non-paretic side, paretic single support, double support time and non-paretic swing time. The CG the differences were detected on double support, paretic single support and hip range of movement. The EG showed better results when compared to CG on the variables: speed (p=0,034), non-paretic single support (p=0,02) and paretic swing time (p=0,02). CONCLUSION: gait training on sloping surfaces represents a promising strategy for gait training of subjects with chronic hemiparesis since it is can influence a greater number of gait variables, when compared with gait training on flat surface