Robotic Therapy and Transcranial Direct Current Stimulation in Patients With Stroke (ROTS)
Visão geral do estudo
Status
Condições
Descrição detalhada
Our main goal is to confirm the safety of robotic therapy associated with active tDCS and conventional therapy, compared to robotic therapy associated with sham tDCS and to conventional therapy, and to conventional therapy alone, for upper limb rehabilitation in an early phase (3-9 weeks) after stroke. Patients will be randomized to receive one of these three treatments, 3 times per week, for 6 weeks.
Data about eventual adverse effect will be collected in each session of treatment. The working hypothesis is that robotic therapy associated with active tDCS and conventional therapy will be as safe as robotic therapy associated with conventional therapy, and as conventional therapy alone.
We will aso preliminarily evaluate the efficacy of robotic therapy associated with active tDCS and conventional therapy, compared to robotic therapy associated with sham tDCS and to conventional therapy alone, in improvement of upper limb motor impairment.
Our secondary goals are: 1) To evaluate safety and upper limb motor impairments in patients submitted to each of the three interventions, 6 months after end of treatment; 2) To compare effects of the abovementioned interventions on disability, spasticity and quality of life, in patients at an early stage after stroke, immediately after treatment and 6 months later.
The working hypothesis is that the association of robotic therapy, tDCS and conventional therapy will lead to better outcomes than robotic therapy and conventional therapy, or conventional therapy alone.
Patients will be assessed before the first session and after the last session of treatment, as well as 6 months after the last session of treatment.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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SP
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São Paulo, SP, Brasil, 05403900
- Hospital das Clinicas
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Ischemic or hemorrhagic stroke onset 3 - 9 weeks before the recruiting, confirmed by computed tomography or magnetic resonance imaging.
- Moderate to severe motor impairment of an upper limb, defined as a score between 7 - 42 on the Upper Limb Subscale of Fugl Meyer Assessment of Sensorimotor Recovery after stroke.
- Ability to provide written informed consent (patient ou legal representative)
- Ability to comply with the schedule of interventions and evaluations in the protocol.
Exclusion Criteria:
- Severe spasticity at the paretic elbow, wrist or fingers, defined as a score of > 3 on the Modified Ashworth Spasticity Scale.
- Upper limb plegia
- Uncontrolled medical problems such as end-stage cancer or renal disease
- Pregnancy
- Seizures, except for a single seizure during the first week post stroke
- Pacemakers
- Other neurological disorders such as Parkinson's disease
- Psychiatric illness including severe depression
- Aphasia ou severe cognitive deficits that compromise comprehension of the experimental protocol or ability to provide consent.
- Hemineglect
- Drugs that interfere on cortical excitability, except for antidepressants
- Cerebellar lesions
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Active tDCS + robotic therapy + physical therapy
Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes. Number of treatment sessions: 18 (3 times a week, for 6 weeks). |
A terapia robótica (MIT - Manus, Interactive Motion Technologies) será administrada por 40 minutos no membro superior parético.
Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).
Physical therapy will be administered for 40 minutes.
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Comparador Ativo: sham tDCS + robotic therapy + physical therapy
Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes. Number of treatment sessions: 18 (3 times a week, for 6 weeks). |
A terapia robótica (MIT - Manus, Interactive Motion Technologies) será administrada por 40 minutos no membro superior parético.
Physical therapy will be administered for 40 minutes.
In sham tDCS, no current will be delivered through the tDCS device.
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Experimental: sham tDCS + physical therapy + occupational therapy
Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).
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Physical therapy will be administered for 40 minutes.
In sham tDCS, no current will be delivered through the tDCS device.
Occupational therapy will be administered for 40 minutes.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Upper Extremity Fugl Meyer Assessment
Prazo: 6 weeks from baseline
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Change in Motor function subscale was assessed.
Scores range from 0 to 66. Lower scores indicate greater severity.
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6 weeks from baseline
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Percentage of Sessions With Adverse Events
Prazo: Post treatment (6 weeks from baseline).
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Post treatment (6 weeks from baseline).
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Modified Rankin Scale
Prazo: 6 weeks from baseline
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Scores range from 0 to 6. Higher scores indicate greater severity.
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6 weeks from baseline
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Change in National Institutes of Health Stroke Scale
Prazo: 6 weeks from baseline
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Scores range from 0 to 42.
Higher scores indicate greater severity.
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6 weeks from baseline
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Change in Stroke Impact Scale
Prazo: 6 weeks from baseline
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Scores in each domain of the Stroke Impact Scale range from 0 to 100, with higher scores indicating a better quality of life.
The change was calculated as the value at the later time point minus the value at the earlier time point; so that, positive numbers represent increases and negative numbers represent decreases.
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6 weeks from baseline
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Number of Participants Who Presented Score on Modified Ashworth Scale >2
Prazo: 6 weeks
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Scores range from 0 to 4, with 5 choices.
A score of 1 indicates no resistance, and 4 indicates rigidity.
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6 weeks
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Change in Motor Activity Log
Prazo: 6 weeks from baseline
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Each domain contains taks scored on 0 to 5 ordinal scale.
Lower scores indicate greater severity.
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6 weeks from baseline
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Upper Extremity Fugl Meyer Assessment
Prazo: 6 months follow-up
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Motor function subscale was assessed.
Scores range from 0 to 66. Lower scores indicate greater severity.
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6 months follow-up
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Number of Participants With Adverse Events
Prazo: 6 months follow-up
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6 months follow-up
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Change in Fatigue Severity Scale
Prazo: 6 weeks from baseline
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Fatigue Severity Scale is a 9 -item questionnaire. Each item scores on a 7-point scale. The total score range from 9 to 63 points. Higher scores indicate greater fatigue. |
6 weeks from baseline
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Change in Pittsburgh Sleep Quality Index
Prazo: 6 weeks from baseline
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The global Pittsburgh Sleep Quality Index score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21. Lower scores denote a healthier sleep quality.
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6 weeks from baseline
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Adriana B Conforto, MD Phd, University of Sao Paulo
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 513.207
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