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Falls-based Training for Walking Post-Stroke (FBT)
Falls-based Training to Improve Balance and Mobility Post-Stroke
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
In 2009, the American Heart Association (AHA) reported that the incidence of hemiplegia in patients six months post-stroke and over 65 years of age was 50%. Stroke survivors with chronic hemiplegia are at an increased risk for falling due to poor motor control, muscle weakness, and balance problems. While over-ground walking training has been shown to improve muscle coordination and functional movement outcomes in stroke survivors, the physical challenges to balance during the training is limited due to safety concerns. The limited training does not reflect the individuals' natural environment, which studies have shown to contain hazards that put post-stroke individuals at greater risk of loss of balance and falls. Therefore, it is important for clinicians to safely implement challenging environmental-hazard tasks as a way to effect greater improvements in walking capability post-stroke.
The usage of body weight support (BWS) during treadmill training has been shown to improve walking speed, but without the context of real world hazards, individuals may not gain improvements in balance related tasks nor gain confidence in moving through hazardous environments. The purpose of this study is to introduce a novel, falls-based training (FBT) approach that will enable individuals to be challenged at high levels of balance and walking safely, using a new robotic device called the KineAssist®, and to determine its relative effects compared to traditional body weight support treadmill training (BWSTT). We hypothesize that like the standard BWSTT, the novel FBT will result in improved walking speed, greater 6 minute walking distance, and greater Berg Balance scores. We also hypothesize that FBT will result in greater gains than BWSTT after the training, with a greater difference 6 months after training. In addition to the walking tests and the Berg Balance scale, we will compare the outcomes of the Stroke Impact Scale (SIS), the Geriatric Depression Scale (GDS)SF-36 Health Survey, the Activities-Specific Balance Confidence (ABC) Scale, the K-9 task Balance test, and the Dynamic Gait Index (DGI).
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Community dwelling unilateral stroke survivors, aged 19 years or older, 4 months to 5 years post incident, residual hemiplegia, who are able to ambulate at least 14m with an assistive device or the assistance of one person, with receptive and expressive communication capability, approval of physician, and voluntarily provided informed consent.
Exclusion Criteria:
- Significant and acute medical conditions, amputations, spasticity management that included phenol block injections within 12 months or botulinum toxin injections within 4 months of the study, any cognition involvement that impairs the ability to follow directions for, and plans to move out of the area within the next year or no transportation to the study area.
Plano de estudo
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 |
|---|---|
|
Comparador Ativo: Hands-Free Walking
Body-weight supported treadmill training
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Walking on a treadmill at 60-80% maximum heart rate without holding onto anything
|
|
Experimental: Challenge Based plus Hands-Free
9 different balance and locomotor challenges applied during walking while not holding onto anything
|
Walking on a treadmill at 60-80% maximum heart rate without holding onto anything under 9 different challenging conditions
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
10 m walk test
Prazo: 6 weeks
|
6 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: David A Brown, PhD, University of Alabama at Birmingham
Publicações e links úteis
Publicações Gerais
- Graham SA, Roth EJ, Brown DA. Walking and balance outcomes for stroke survivors: a randomized clinical trial comparing body-weight-supported treadmill training with versus without challenging mobility skills. J Neuroeng Rehabil. 2018 Nov 1;15(1):92. doi: 10.1186/s12984-018-0442-3.
- Naidu A, Brown D, Roth E. A Challenge-Based Approach to Body Weight-Supported Treadmill Training Poststroke: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 May 3;7(5):e118. doi: 10.2196/resprot.9308.
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- F120425008
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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