- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01121627
Computer-based Cognitive Training for Parkinson Disease
Effects of Computer-based Cognitive Training on Gait Function in Individuals With Parkinson Disease
Parkinson's Disease (PD) is a neurodegenerative, progressive illness. It is a multi-system disease that influences not only the motor but also the cognitive and autonomic systems. The main cognitive impairment in individuals with PD is found in executive function (EF). EF is defined as a set of cognitive skills necessary for planning, monitoring and executing sequences of complex activities.
The primary study hypothesis is that computer-based training aimed at improving executive function will have a beneficial effect on gait functions.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
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Haifa, Israel
- Clalit Health Services, Haifa and Western Galilee District
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Idiopathic PD.
- Aged 50-80, living in north region of Israel.
- Receive regular medications for PD.
- Not suffering from irregular cognitive disturbance or MMSE<25.
- Measured 1-3 on the Hoehn & Yahr scale.
- Have access to a computer and the ability to operate it.
Exclusion Criteria:
- Brain operation, including DBS transplant.
- History of orthopedic problems that can impair gait (hip/knee fractures and back problems).
- Orthopedic operation on lower limbs performed no later than six months prior to the beginning of the study.
- Unbalanced general health: uncontrolled diabetes or blood pressure, etc.
- Inability to walk independently.
- Immunodeficiency diseases, active cancer, ischemic diseases.
- Vision impairment, partial/full blindness.
- Having participated in similar research or cognitive assessment during the previous year.
- Have received cognitive or gait training under physical therapy or other programs.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Computerized cognitive training
A 12 week computerized cognitive training
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A 12 week computerized cognitive training at home with the Attengo™ software program.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Gait Function
Prazo: 18 weeks
|
At enrollment eligible individuals will undergo a thorough baseline assessment using a predefined set of tests and performance measurements.
Within a week after enrollment each individual will receive guided training on the use of the intervention tool, the Attengo™ software program.
Thereafter they will train at their homes, at least three times a week, for a period of 12 weeks.
Follow up assessments will be performed within a week of the end of the training period and 4 weeks thereafter to check for long-term cognitive and motor changes.
|
18 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Executive function
Prazo: 18 weeks
|
At enrollment eligible individuals will undergo a thorough baseline assessment using a predefined set of tests and performance measurements.
Within a week after enrollment each individual will receive guided training on the use of the intervention tool, the Attengo™ software program.
Thereafter they will train at their homes, at least three times a week, for a period of 12 weeks.
Follow up assessments will be performed within a week of the end of the training period and 4 weeks thereafter to check for long-term cognitive and motor changes.
|
18 weeks
|
|
Quality of life.
Prazo: 18 weeks
|
At enrollment eligible individuals will undergo a thorough baseline assessment using a predefined set of tests and performance measurements.
Within a week after enrollment each individual will receive guided training on the use of the intervention tool, the Attengo™ software program.
Thereafter they will train at their homes, at least three times a week, for a period of 12 weeks.
Follow up assessments will be performed within a week of the end of the training period and 4 weeks thereafter to check for long-run cognitive and motor changes.
|
18 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Uzi Milman, MD, Clalit Health Services
- Investigador principal: Anat Mirelman, Phd, Tel-Aviv Sourasky Medical Center
- Investigador principal: Hagit Atias, BA, Clalit Health Services
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 (Estimativa)
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
- K-10-0036-ctil
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