Cortical Activity and Gait Function for Robotic Gait Training in Hemiparetic Stroke
9 de febrero de 2020 actualizado por: Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea
Effects of Robotic Gait Training on Cortical Activity and Gait Function in Hemiparetic Stroke
Effects of robot-assisted gait training on cortical activity and gait function in hemiparetic stroke
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
30
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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Seoul, Corea, república de, 142884
- National Rehabilitation Center
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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
19 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Hemiplegic patients secondary to first cerebrovascular accidents
- Functional ambulation category score 3
- 3 months ≤ Onset ≤ 12 months
- Korean Mini-Mental State Examination score > 24
Exclusion Criteria:
- History of surgery of affected lower limb
- Fracture of affected lower limb
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: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Robot-assisted gait training
experimental group that applied the end-effector robot-assisted gait training
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intervention with robot-assisted gait training
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Comparador activo: Treadmill gait training
control group that applied the treadmill gait training
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intervention with treadmill gait training
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
oxygenated hemoglobin levels
Periodo de tiempo: 4 weeks from baseline
|
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
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4 weeks from baseline
|
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Range of motion of ankle, knee, and hip joint
Periodo de tiempo: 4 weeks from baseline
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ankle, knee, and hip joint motion of sagittal plane during gait
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4 weeks from baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
oxygenated hemoglobin levels
Periodo de tiempo: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
Range of motion of ankle, knee, and hip joint
Periodo de tiempo: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
ankle, knee, and hip joint motion of sagittal plane during gait
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
Berg Balance Scale
Periodo de tiempo: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
Berg Balance Scale assess the functional balance ability of participants with observation of 14 tasks, representing functional movements common in daily life.
Each task is scored on a five-point scale (0-4) following the guidelines of the test developers, and the maximum score on this test is 56 which indicates balance ability within the normal range.
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baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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Fugl-Meyer Assessment
Periodo de tiempo: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
Fugl-Meyer Assessment uses to examine the motor function and coordination of affected lower extremity.
It includes 17 items of a 3-point ordinal scale, ranging 0-34, with higher scores indicating lower impairment.
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baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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10m walk test
Periodo de tiempo: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
10m walk test is used to examine gait speed, in which participant was asked to walk on a 14 meter of walkway wearing harness with two conditions; with the fastest speed or with self-selected comfortable speed.
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baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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Functional ambulation category
Periodo de tiempo: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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Functional Ambulation Category is used to assess gait ability with 6 levels ranging from 0 to 5 on the basis of the amount of physical support required, regardless of use of an assistive device
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baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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Falls efficacy scale
Periodo de tiempo: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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Korean version of Falls efficacy scale asks subjects to rank their confidence about their ability not to fall while performing a variety of activities of daily living with a maximum score of 100
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baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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Beck depression inventory
Periodo de tiempo: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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21-question multiple-choice self-report inventory, one of the most widely used psychometric tests
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baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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Stroke impact scale
Periodo de tiempo: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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health-related quality of life poststroke across 8 domains using a 5-point Likert scale, with the score ranging from 0 to 100 and a higher score indicating better health status
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baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
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Dynamic gait index
Periodo de tiempo: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
a clinical tool to assess gait, balance and fall risk
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
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Timed up and go test
Periodo de tiempo: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
a simple test used to assess a person's mobility and requires both static and dynamic balance
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
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modified Barthel index
Periodo de tiempo: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients
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baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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dual task - COWAT
Periodo de tiempo: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
Controlled Oral Word Association Test, abbreviated COWA or COWAT, is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with some designated letter.
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baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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dual task - digit span test
Periodo de tiempo: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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The digit span test is a way of measuring the storage capacity of a person's working memory.
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baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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Electromyography of lower extremities
Periodo de tiempo: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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Muscle activity of tibialis anterior, medial gastrocnemius, vastus medialis, biceps femoris, gluteus medius during gait.
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baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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Plantar pressure
Periodo de tiempo: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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Plantar pressure (great toe, little toe, medial meta, lateral meta, medial arch, lateral arch, heel) during gait
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baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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Spatiotemporal gait parameter data
Periodo de tiempo: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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step length, step time, swing time, double limb support time during gait
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baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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deoxygenated hemoglobin levels
Periodo de tiempo: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
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total hemoglobin levels
Periodo de tiempo: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
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Balance test using force plate
Periodo de tiempo: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
Static standing balance as measured using a force plate: Changes in center-of-pressure velocity and area
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baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
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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)
1 de septiembre de 2018
Finalización primaria (Actual)
30 de noviembre de 2019
Finalización del estudio (Actual)
31 de diciembre de 2019
Fechas de registro del estudio
Enviado por primera vez
12 de agosto de 2019
Primero enviado que cumplió con los criterios de control de calidad
12 de agosto de 2019
Publicado por primera vez (Actual)
13 de agosto de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de febrero de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
9 de febrero de 2020
Última verificación
1 de febrero de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NRC-2017-02-015
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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. .
Ensayos clínicos sobre Robot-assisted gait training
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IRCCS San Raffaele RomaTerminadoCarrera | Trastornos de la marcha, neurológicosItalia