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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03194464
Fatiguing Arm Exercise Following Stroke
Neural Mechanisms Mediating Interlimb Transfer Following Stroke
Visão geral do estudo
Descrição detalhada
The long-term goal is to restore upper extremity (UE) motor function following stroke. The overall objective of this proposal is to improve the investigators' understanding of neural mechanisms contributing to inter-limb and inter-hemispheric transfer following non-paretic limb exercise to task failure. The investigators will use transcranial magnetic stimulation to probe acute adaptations in cortical excitability, intracortical and inter-hemispheric circuits that accompany behavioral facilitation of the paretic hand.
The work proposed in this two year project will enable the investigators to obtain three data elements critical to complete the working hypothesis:
- . Changes in intracortical and interhemispheric inhibition in both hemispheres following non-paretic limb exercise to task-failure.
- . Behavioral effects using a motor task involving manipulation and dexterity.
- . Determine the persistence and consistency of neural and behavioral facilitation.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Florida
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Gainesville, Florida, Estados Unidos, 32608
- North Florida/South Georgia Veterans Health System, Gainesville, FL
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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:
- individuals at least 6 months post-stroke in the cortical or sub-cortical distribution with residual upper-extremity hemiparesis
- Non-Veteran Participants are eligible
Exclusion Criteria:
- multiple strokes
- strokes in both hemispheres
- brainstem/medullary/cerebellar stroke
- seizure disorder
- metal implants in head or neck
- pacemaker or other implanted device
- inability to produce any measurable grip force
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Task-failure, Extended Session
Repeated sub-maximal gripping exercise with the less affected hand to task-failure - followed by repeated measurements (5) during recovery period
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participants perform repeated gripping with visual feedback to task failure
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Short Intracortical Inhibition (SICI)
Prazo: baseline, post task-failure (minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total)
|
SICI is a neurophysiologic measure of intra-cortical inhibition, obtained using transcranial magnetic stimulation (TMS) measured here in the ipsilesional hemisphere (IH) at each point to determine how it is modulated in response to task-failure.
SICI is quantified as a ratio where values <1 reflect inhibition and >1 disinhibition or relative excitation.
In health, SICI is ~0.5.
Thus if SICI = 0.8, while <1 it would indicate less inhibition than expected in health.
Transient change in SICI from 0.8 to 1.1 over the course of this experimental paradigm would reflect a period of relative excitation in response to the exercise paradigm.
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baseline, post task-failure (minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total)
|
SICI Ratio
Prazo: Baseline, pre-exercise of 8 repeated sessions
|
SICI is a neurophysiologic measure of intra-cortical inhibition, obtained using transcranial magnetic stimulation (TMS) measured here in the ipsilesional hemisphere (IH) at each point to determine how it is modulated in response to task-failure.
SICI is quantified as a ratio where values <1 reflect inhibition and >1 disinhibition or relative excitation.
In health, SICI is ~0.5.
Thus if SICI = 0.8, while <1 it would indicate less inhibition than expected in health.
Transient change in SICI from 0.8 to 1.1 over the course of this experimental paradigm would reflect a period of relative excitation in response to the exercise paradigm.
|
Baseline, pre-exercise of 8 repeated sessions
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Box and Blocks Test (BBT)
Prazo: baseline, post task-failure (requires variable timeline from minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total)
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The BBT measures motor function/dexterity, scored as the number of blocks transferred in 1 minute.
Here function of the paretic hand was measured at each time point: baseline, post-task failure, 45min post, 90min post, 135min post, 180min post, 225min post-task failure to determine the change in paretic hand BBT performance following exercise to task-failure.
Scores are numeric ranging from 0 (no blocks transferred) to whatever the participant is able to achieve.
Healthy age-matched adults without motor disability score in the range of 60 (+/- 10) blocks transferred in 1 minute.
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baseline, post task-failure (requires variable timeline from minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total)
|
Box and Blocks Test (BBT)
Prazo: baseline, pre-exercise of 8 repeated sessions
|
The BBT measures motor function/dexterity, scored as the number of blocks transferred in 1 minute.
Here function of the paretic hand was measured prior to exercise at each of 8 repeated sessions conducted twice weekly for 4 weeks to determine the change in paretic hand BBT performance following repeated sessions of exercise to task-failure.
Scores are numeric ranging from 0 (no blocks transferred) to whatever the participant is able to achieve.
Healthy age-matched adults without motor disability score in the range of 60 (+/- 10) blocks transferred in 1 minute.
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baseline, pre-exercise of 8 repeated sessions
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Carolynn Patten, PhD, North Florida/South Georgia Veterans Health System, Gainesville, FL
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
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
- N1759-P
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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