Ankle Robot to Reduce Foot Drop in Stroke
8 de maio de 2020 atualizado por: VA Office of Research and Development
Adaptive Ankle Robot Control System to Reduce Foot-drop in Chronic Stroke
Deficits in ankle control after stroke can lead to foot drop, resulting in inefficient, aberrant gait and an elevated falls risk.
Using a novel ankle robot and newly invented adaptive control system, this study tests whether robotic-assisted treadmill training will improve gait and balance functions in chronic stroke survivors with foot drop impairment.
It is hypothesized that, compared to treadmill training alone, integrating adaptive ankle robotics with treadmill training will reduce drop foot during independent overground walking, resulting in greater mobility, improved postural control, and reduced fall risk.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
This proposal investigates a novel ankle robot (anklebot) adaptive control approach integrated with treadmill training to reduce foot drop and improve mobility function in chronic hemiparetic stroke survivors. Currently, stroke survivors with foot drop are trained to live with a cane or other assistive device, and often ankle foot orthotics (AFOs) for safety. Neither mediates task-practice or neuromotor recovery.
The investigators have developed an adaptive anklebot controller that detects gait cycle sub-events for precise timing of graded robotics assistance to enable deficit severity-adjusted ankle motor learning in the context of walking. The investigators' pilot findings show that 6 weeks treadmill training with anklebot (TMR) timed to assist swing phase dorsiflexion only is more effective than treadmill alone (TM) to improve free-walking swing dorsiflexion at foot strike, floor-walking speed, and the benefits are retained at 6 weeks post-training. Notably, swing-phase TMR training improved paretic leg push-off, and reduced center-of-pressure sway on standing balance, indicating potential benefits to other elements of gait and balance, beyond those robotically targeted toward foot drop.
This randomized study investigates the hypothesis that 6 weeks TMR is more effective to improve durably gait biomechanics, static, and dynamic balance, and mobility function in chronic stroke survivors with dorsiflexion deficits, compared to TM alone. Aims are to determine the compare effectiveness of 6 weeks TMR vs. TM alone on:
- Independent gait function indexed by gait velocity, swing-phase DF (dorsiflexion), terminal stance push-off.
- Balance function indexed by measures of postural sway (CoP), asymmetric loading in quiet standing, peak paretic A-P forces in non-paretic gait initiation, and standardized scales for balance and fall risk.
- Long-term mobility outcomes, assessed by repeated measures of all key gait and balance outcomes at 6 weeks and 3 months after formal training cessation.
Tipo de estudo
Intervencional
Inscrição (Real)
45
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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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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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 e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Ischemic or hemorrhagic stroke > 2 months prior in men or women
- Residual hemiparesis of the lower extremity that includes symptoms of foot drop
- Capable of ambulating on a treadmill with handrail support
- Already completed all conventional physical therapy
- Adequate language and cognitive function to provide informed consent and participate in testing and training
Exclusion Criteria:
Cardiac history of:
- Unstable angina
- Recent (< 3 months) myocardial infarction
- Congestive heart failure (NYHA category II or higher)
- Hemodynamic valvular dysfunction
- Hypertension that is a contraindication for a bout of treadmill training (>160/100 mmHg on two assessments)
Medical history of:
- Recent hospitalization (< 3 months) for any serious condition leading to significant bed-rest or reduction in mobility function
- Symptomatic peripheral arterial occlusive disease
- Orthopedic or chronic pain conditions restricting exercise
- Pulmonary failure requiring oxygen
- Uncompensated renal failure
- Active cancer
Neurological history and exam consistent with:
- Dementia
- Receptive or global aphasia that confounds testing and training, operationally defined as unable to follow 2-point commands
- Non-stroke neurological disorder restricting exercise (e.g. Parkinson's Syndrome, myopathy)
- Untreated major depression
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: Treadmill+anklebot
This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.
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This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period.
Outros nomes:
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Comparador Ativo: Treadmill only
This group will receive gait training on a treadmill, without use of the anklebot.
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This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period
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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Gait Velocity During Self-selected Overground Walking
Prazo: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
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Gait velocity during self-selected overground walking measured in cm/sec
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Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
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Anterior-posterior Propulsion Forces of Paretic Side During Gait
Prazo: Change from baseline to: Post 6-weeks training, 6 weeks after completion, and 3 (or 6) months
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Newtons: anterior-posterior force generated during push-off phase of the gait cycle
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Change from baseline to: Post 6-weeks training, 6 weeks after completion, and 3 (or 6) months
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Peak Dorsiflexion Angle During Swing Phase of Gait
Prazo: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
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Degrees; extent of ankle dorsiflexion to enable foot clearance
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Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
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Postural Sway Areas During Quiet Standing
Prazo: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
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cm^2; extent of postural deviations to assess static postural control
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Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
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Ratio of Asymmetric Loading in Quiet Standing
Prazo: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
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Ratio of Newtons of force per each leg (paretic/nonparetic) while standing quietly
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Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
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Peak Paretic Push Off Forces During Gait Initiation
Prazo: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
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Newtons; magnitude of forward ground reaction forces
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Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Steven J Kittner, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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 setembro de 2015
Conclusão Primária (Real)
1 de abril de 2019
Conclusão do estudo (Real)
30 de junho de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
19 de junho de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de junho de 2015
Primeira postagem (Estimativa)
29 de junho de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
20 de maio de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de maio de 2020
Última verificação
1 de maio de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- N1699-R
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Sim
produto fabricado e exportado dos EUA
Não
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