- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02785419
Action Selection and Arm Rehabilitation After Stroke
16 de julio de 2021 actualizado por: Jill Stewart, PT, PhD, University of South Carolina
Targeted Engagement of the Motor Action Selection Network During Arm Rehabilitation After Stroke
After stroke, individuals often have persistent difficulty using the arm and hand in everyday functional tasks that reduces quality of life.
Currently available rehabilitation techniques are not adequate and new protocols are needed that are based on an understanding of how brain regions work together to produce skilled movement.
This research project aims to improve our understanding of how the brain controls movement after stroke and determine whether a period of motor practice that targets specific brain regions through the addition of action selection demands leads to improved arm function.
We hypothesize that arm motor function and the ability to efficiently activate the action selection motor circuit during movement will improve after training.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Rehabilitation of arm impairment after stroke includes the repetitive practice of functional tasks.
In healthy adults, planning plays a vital role in the control of skilled movement, however, the behavioral and neural correlates of planning have largely been unexplored in individuals recovering from stroke.
Action selection is an important motor planning process that engages dorsal premotor cortex (PMd) in controls.
While PMd activation is a commonly reported neural correlate of motor recovery after stroke, the role of PMd in action selection and motor training are not known.
Therefore, the purpose of this study is to determine the effect of training that includes action selection demands on the behavioral and neural correlates of movement after stroke.
Thirty-eight individuals in the chronic phase of stroke will be recruited.
After completion of clinical measures of impairment and function, all participants with stroke will complete a motor action selection task and functional MRI followed by arm training.
Arm training will consist of three weeks (15 sessions) of arm motor training (1.5 hours per session) that includes action selection demands on movement.
Follow-up clinical testing will occur at the end of treatment and three weeks later.
Tipo de estudio
Intervencionista
Inscripción (Actual)
32
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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South Carolina
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Columbia, South Carolina, Estados Unidos, 29208
- University of South Carolina
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- At least 18 years old
- Had stroke at least 6 months ago
- Right-hand dominant prior to stroke
- Some continued arm and hand weakness
- Some ability to move the arm and hand that is weaker from the stroke
Exclusion Criteria:
- Acute medical issues that would interfere with participation
- Another neurologic diagnosis that may impact movement (e.g. Parkinson's Disease)
- Cannot undergo MRI scanning
- Severe apraxia or hemispatial neglect
- Pain in the arm that interferes with movement
- Difficulty maintaining attention or following directions
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Arm Training with Action Selection
Task-oriented, functional arm training with the addition of action selection cues to practice.
All participants receive the same arm training intervention.
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Treatment occurs in 1.5 hour sessions, 5 times a week for 3 weeks.
In each treatment session, you will practice functional tasks with your weaker arm and hand.
Additionally, you will be given cues on a computer screen that dictate your movement response (action selection).
Practice will be scaled to match your current level of function and progressed over time as able.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Action Research Arm Test
Periodo de tiempo: Change from baseline to end of treatment (3 weeks)
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Behavioral assessment of arm function.
Scores range from 0 to 57 with a higher score equating to better function.
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Change from baseline to end of treatment (3 weeks)
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Brain activation during functional MRI
Periodo de tiempo: Change from baseline to end of treatment (3 weeks)
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Brain activation during movement will be captured with functional MRI.
Analyses will investigate changes in magnitude of activation.
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Change from baseline to end of treatment (3 weeks)
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Brain connectivity during functional MRI
Periodo de tiempo: Change from baseline to end of treatment (3 weeks)
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Brain activation during movement will be captured with functional MRI.
Analyses will investigate changes in connectivity between brain regions.
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Change from baseline to end of treatment (3 weeks)
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Upper Extremity Fugl-Meyer Motor Assessment
Periodo de tiempo: Change from baseline to end of treatment (3 weeks)
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Change from baseline to end of treatment (3 weeks)
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Stroke Impact Scale Hand Domain
Periodo de tiempo: Change from baseline to end of treatment (3 weeks)
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Change from baseline to end of treatment (3 weeks)
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Box & Blocks Test
Periodo de tiempo: Change from baseline to end of treatment (3 weeks)
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Change from baseline to end of treatment (3 weeks)
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9-Hole Peg Test
Periodo de tiempo: Change from baseline to end of treatment (3 weeks)
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Change from baseline to end of treatment (3 weeks)
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Grip Strength
Periodo de tiempo: Change from baseline to end of treatment (3 weeks)
|
Change from baseline to end of treatment (3 weeks)
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Confidence in Arm and Hand Movements Questionnaire
Periodo de tiempo: Change from baseline to end of treatment (3 weeks)
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Change from baseline to end of treatment (3 weeks)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
8 de diciembre de 2015
Finalización primaria (Actual)
1 de diciembre de 2020
Finalización del estudio (Actual)
1 de diciembre de 2020
Fechas de registro del estudio
Enviado por primera vez
9 de mayo de 2016
Primero enviado que cumplió con los criterios de control de calidad
24 de mayo de 2016
Publicado por primera vez (Estimar)
27 de mayo de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de julio de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
16 de julio de 2021
Última verificación
1 de julio de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Pro00032516
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .