Effects of Training in a Virtual Environment in Chronic Stroke Patients
1 de novembro de 2018 atualizado por: University of Sao Paulo General Hospital
Effects of Training in a Virtual Environment on the Motor Function,Postural Control and Quality of Life in Chronic Stroke Patients: A Randomized Controlled Trial
The objective of this work will be compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, on the (1) motor function, (2) cognition, (3) balance and (4) gait in chronic stroke patients.
It is a prospective, single blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University.
Forty patients will be randomly assigned in control and experimental group, 20 each one.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
The objective of this work is to compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, motor function, balance and quality of life in chronic stroke patients.
It is a prospective, single-blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University.
Forty chronic stroke patients are randomly in control and experimental group, 20 each one.
Both groups conduct 14 training sessions, twice a week, for seven weeks.
Each session will consist a 30 minute-global-exercise series including stretching, muscle strength and axial mobility exercises.
After this, both groups will performed more 30 minutes of balance training: the control group will performed balance exercises without external cues, visual or auditory feedbacks or cognitive stimulations; the experimental group will performed the balance training with 8 Wii Fit games which stimulate motor and cognitive functions.
The main outcome measures will be: (1) the lower limb subscale of the Fugl-Meyer Assessment (FMA-LE); (2); Balance Evaluation Systems Test (BESTest);(3) the Stroke-Specific Quality of Life (SS-QOL); (4) 6- minute walk test (6MWT) and (5) The limits of stability (LOS).
Tipo de estudo
Intervencional
Inscrição (Real)
40
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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São Paulo, Brasil, 05360-160
- Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- hemiparetic status resulting from a single stroke at least 6 months earlier;
- the ability to walk 10 m independently with or without an assistive device;
- the absence of a musculoskeletal condition that could potentially affect the ability to walk safely;
- the absence of serious visual impairment or a hearing disorder;
- power of at least grade 3 in the hemiplegic lower extremity;
- able to understand and follow simple instructions.
Exclusion Criteria:
- a Montreal Cognitive Assessment (MoCA) score of < 20;
- severe dementia or aphasia;
- hemispatial neglect, ataxia or any other cerebellar symptom;
- inability to stand without minimal assist;
- Impaired vision
- Uncontrollable medical complications
- participation in other studies or rehabilitation programs
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Virtual Reality Training
The virtual reality training will be done by experimental group with ten games of Nintendo Wii Fit.
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The participants of the study will be trained 8 balance games during 14 sessions
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Comparador Ativo: Control group: Physical Therapy
The Control Group will be trained by conventional Physical Therapy exercises.
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Patients of the control group will be trained with balance exercises.
Outros nomes:
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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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The lower limb subscale of the Fugl-Meyer Assessment (FMA-LE)
Prazo: up to 2 months
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FMA-LE is a subscale measuring lower limb motor recovery.
It examines movement and coordination of the hip, knee, and ankle in the supine, sitting, and standing positions.
Each item is scored on a 3-point scale (0, cannot perform; 1, partially performs; 2, performs fully).
The score range is 0 to 34, with higher scores indicating better lower limb motor performance
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up to 2 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Balance Evaluation Systems Test (BESTest)
Prazo: Up 2 months
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Balance Evaluation Systems Test (BESTest) measures balance.
It includes 36 items that evaluate performance of 6 balance systems: biomechanical constraints, stability limits/verticality, anticipatory postural adjustments, postural responses, sensory orientation, and stability in gait.
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Up 2 months
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6-minute walk test
Prazo: Up to 2 months
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The 6MWT is a practical simple test.
This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD).
The 6MWT has been used as a measure of functional status of patients.
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Up to 2 months
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Stroke specific quality of life scale
Prazo: Up to 2 months
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Stroke Specific Quality of Life Scale is a self-report assessment that includes 12 stroke specific subscales with 49 items.
The Stroke Specific Quality of Life Scale attempts to capture the domains of stroke specific QOL that are insufficiently assessed with generic QOL measures.
The 12 subscales, which are unidimensional, are Energy, Family Role, Language, Mobility, Mood, Personality, Self-Care, Social Roles, Thinking, Upper Extremity Function, Vision, and Work-Productivity.
Participants responded to each item on a 5-point scale.
Domain scores are the averages of the item scores, and the total score is the average of the domain scores.
All summary scores therefore range from 1 to 5. Higher scores indicate better function.
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Up to 2 months
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Limits of Stability
Prazo: Up to 2 months
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The Limits of Stability subtest quantifies the maximum distance a person can intentionally displace their center of pressure (COP) from start position of midline COP centered over the base of support to eight targets.
Location and movement of the COP was indicated by a cursor display projected on a screen in front of the subject.
As targets were highlighted, the subject was to move the COP cursor quickly and accurately as possible towards a target located on the Limits of Stability perimeter and hold position as close to the target as possible.
The parameters include COP movement velocity and directional control (% to target).
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Up to 2 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Tatiana P Oliveira, PhD student, University of Sao Paulo
- Investigador principal: Camila S Miranda, Ms Student, University of Sao Paulo
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de fevereiro de 2014
Conclusão Primária (Real)
1 de junho de 2017
Conclusão do estudo (Real)
1 de fevereiro de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
20 de junho de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de junho de 2013
Primeira postagem (Estimativa)
25 de junho de 2013
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de novembro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de novembro de 2018
Última verificação
1 de julho de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- USPNEC005
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