New Protocols in the Treatment of Upper Limb Dysfunctions of Patients With Stroke.
New Protocols in the Treatment of Upper Limb Dysfunctions of Patients With Stroke: An Evidence of Clinical and Kinematic Studies.
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The research program aims at studying patients with stroke the immediate and maintaining effects of new upper-extremity (UE) treatment protocols after brain damage and identifying the possible mechanisms underlying treatment-induced changes in patients with stroke. This research will study new treatment approaches that have been formulated based on principles of integrated central modulation (rTMS) and peripheral modification techniques (BoNTA).
- To compare the movement functions and motor control in patients with stroke of different motor severities.
- To investigate the immediate and maintaining effects of different protocols in the treatment of upper limb functions.
To evaluate motor control and clinical outcomes after different treatment approaches applied in the UE training of patients with stroke. The treatment approaches to be studied will include different protocols. We hypothesize that there will be improvements in movement performance after the treatment and the level of post-treatment performance will differ among the treatments through different reorganization patterns.
3.1 To compare the motor control and clinical outcomes after different treatment approaches.
3.2 To identify the optimal treatment protocol for patients with stroke.
- To investigate the possible predictors of treatment outcome associated with motor severity, movement and participation for each type of treatments. The possible predictors will include brain lesions, and severity. We hypothesize that the proposed prognostic factors will predict treatment outcomes.
- To analyze the association between motor reorganization measured by kinematic study and behavioral improvement in motor severity, movement and participation measured by clinical tools.
Treating motor dysfunction in patients with stroke requires an understanding of the mechanism underlying motor control. Recent reports have suggested BoNTA and rTMS improved motor function in patients with various disorders. However, there are few researches in identifying the optimal rTMS protocol in the treatment of upper limb dysfunctions in patients with stroke. There is lack of literatures in verifying the treatment effect by movement control studies. The current research will offer valuable kinematic data that support neural-motor models proposed to account for motor control problems in these patients. More important, we will identify the new protocol in the treatment of upper limb dysfunctions in patients with stroke through integration of clinical and kinematic measures. We will identify clinical predictors influencing the outcome for different treatment approaches, and analyze the association between motor control and clinical measures involving motor severity, movement and participation. We believe the results of this study will refine services and supports for patients with stroke to meet these goals. This study may potentially provide directions in kinematic measures for future studies on patients with stroke.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Taoyuan, Taiwan, 333
- Chang Gung Memorial Hospital
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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:
- Age: 20-80 y/o
- patients with 1st onset cerebral stroke.
Exclusion Criteria:
- Brain stem or cerebellar stroke
- Contraindication to MRI, such as metallic implant
- Contraindication to BoNTA, such as poor controlled epilepsy
- History of psychiatric disease
- Received BoNTA injection or surgery in recent six months
- Severe psychological impairments, such as mental retardation, autism, or severe Communication problems
- Progressive disorders, such as neurodegenerative disease
- Active medical disease, such as infection
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: grupo iTBS
Na estimulação intermitente theta burst (grupo iTBS), eles receberam iTBS (80% do limiar motor ativo) no hemisfério afetado.
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In intermittent theta burst stimulation pattern (iTBS) will intermittently give a 2 s train of TBS every 10s for a total of 20 times (low pulse: 600 pulses in total)
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Experimental: grupo cTBS
Na estimulação theta burst contínua (grupo cTBS), eles receberam cTBS (80% do limiar motor ativo) no hemisfério não afetado.
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In continuous burst stimulation pattern (cTBS) will intermittently give a cTBS treatment consists of a continuous train of TBS for 40 seconds(low pulse: 600 pulses in total).
Outros nomes:
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Comparador Falso: grupo TBS falso
Na estimulação simulada de explosão theta (grupo TBS simulado), eles receberam estimulação simulada de TBS.
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In sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds(almost no pulse: 600 pulses in total).
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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 from baseline of Kinematic analysis after 2 weeks treatment and 3 months , 12 months follow up.
Prazo: baseline, after treatment, 3 months , 6 months
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Kinematic analysis for upper limb analysis.
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baseline, after treatment, 3 months , 6 months
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Colaboradores e Investigadores
Patrocinador
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
- 100-0012A3
Plano para dados de participantes individuais (IPD)
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