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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03232879
Combining Motor Imagery With Action Observation Does Not Lead to a Greater Autonomic Response Than Motor Imagery Alone During Simple and Functional Movements: a Randomized Controlled Trial.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Motor Imagery (MI) is defined as a dynamic mental process that involves the representation of an action, in an internal way, without its actual motor execution. The Action Observation (AO) evokes an internal, real-time motor simulation of the movements that the observer is perceiving visually. Both mental processes trigger the activation of the neurocognitive mechanisms that underlie the planning and execution of voluntary movements in a manner that resembles how the action is performed in a real manner.
Both observation and imagination share a great number of common mental processes based primarily on sensory perception, and the information stored by memory systems. The activation of the motor command during a mental practice does not induce an active movement probably due to an inhibitory mechanism in the primary motor cortex on the descending corticospinal tract pathways. However, this inhibition is not complete, for it is well known that the training of mental practice involves a component of the autonomic nervous system (ANS).
It has been shown that both MI and AO lead to changes in the ANS that cause excitatory sympathetic responses, although the neurophysiological bases remain uncertain and are still based on hypotheses. The functional relations between both neurocognitive processes and the sympathetic-excitatory nervous system (SNS) could be based on a preparation phase in which, the activation of the SNS, happens to a near effort and, therefore, to a close energy expenditure in physiological processes (i.e., cardiorespiratory adaptationse) which will take place in order to face said metabolic changes produced by the voluntary movement itself. In addition, several hypotheses have been described regarding the notion that the SNS not only has the quantitative objective of providing energy to the muscle effectors, but that it also qualitatively and specifically designs and adapts the parameters on demand in an attempt to save the energy provided for each precise motor execution.
Taking into account that both MI and AO cause sympathetic-excitatory changes that induce an increase in heart rate, blood pressure, respiratory rate, electrodermal activity , our hypothesis is that the combination of MI and AO induces an autonomic sympathetic-excitatory shift greater than MI does in isolation. Therefore, the main objective of this study was to compare the results obtained from intervention groups on the subject of the activation of the SNS in a program that combined MI with AO, in contrast to an isolated MI program on the one hand in asymptomatic subjects and in the other hand in patients with chronic low back pain.. The secondary objective of the present study was to explore whether there is any relationship between the sympathetic-excitatory response and the ability to generate motor imagery, the mental chronometry, and the level of physical activity.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Madrid, España, 28023
- CSEU La Salle
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria asymptomatic subjects:
- Age between 18 and 60
- Healthy and with no pain subjects
Inclusion Criteria patients with chronic low back pain:
- Low back pain for at least the prior 3 months
- Low back pain of nonspecific nature
- Age between 18 and 60
- Low back pain for at least 10 days per month
- Intensity of pain of between 3 and 10 on the Visual Analogue Scale
Exclusion Criteria asymptomatic subjects:
- Any cognitive impairment that hindered viewing of audiovisual material.
- Difficulty understanding or communicating.
- Presence of systemic pathology, Central Nervous System or rheumatic disease.
- Inadequate understanding of the Spanish language to follow instructions for measuring and treatment.
- Collaboration of pregnant women.
- Underage subjects
- Subjects with pain at the time of the study.
Exclusion Criteria patients with chronic low back pain:
- Any cognitive impairment that hindered viewing of audiovisual material.
- Difficulty understanding or communicating.
- Presence of systemic pathology, Central Nervous System or rheumatic disease.
- Inadequate understanding of the Spanish language to follow instructions for measuring and treatment.
- Collaboration of pregnant women.
- Underage subjects
- Having undergone back surgery
- Specific spinal pathology
- Recent trauma
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Experimental 1
Motor Imagery
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Two consecutive 30 seconds imagery tasks were performed, both based on two movements that are recorded in the Revised Movement Imagery Questionnaire (MIQ-R).
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Experimental: Experimental 2
Action Observation
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Two consecutive 30 seconds imagery tasks were performed, both based on two movements that are recorded in the Revised Movement Imagery Questionnaire (MIQ-R).
Before the subjects performed the mental MI practice, they were presented with a 30 seconds video that displayed the task that they ought to imagine later.
A video was played prior to the first practice of imagination and after the second mental practice, a second video was shown.
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Sin intervención: Grupo de control
Sin intervención
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Electrodermal Activity
Periodo de tiempo: Change in electrodermal activity after 5 minutes post-intervention
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Electrodermal Activity will be measured through the use of two electrodes that recorded changes in conductance through the skin located at the back of the dominant hand
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Change in electrodermal activity after 5 minutes post-intervention
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Respiration Rate
Periodo de tiempo: Change in respiration rate after 5 minutes post-intervention
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Respiration Rate will be measured through a pressure transducer located in the centre of the chest, where it was fixed by a strap
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Change in respiration rate after 5 minutes post-intervention
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Heart Rate
Periodo de tiempo: Change in heart rate after 5 minutes post-intervention
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Heart Rate will be measured by three electrodes located in the left area of the chest.
One of the electrodes was placed in the middle zone while a second electrode was positioned on the lateral side, and a third one on the lower left side, below the first electrode.
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Change in heart rate after 5 minutes post-intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Habilidad de imágenes motoras visuales y cinestésicas
Periodo de tiempo: Pre-intervención
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La capacidad de visualización de imágenes motoras cinestésicas y visuales se medirá con el cuestionario MIQ-R.
MIQ-R tiene 4 movimientos repetidos en dos subescalas, una visual y otra cinestésica.
Además, se asigna una puntuación entre 1 y 7, siendo 1 la dificultad para visualizar la imagen motriz o la dificultad para sentir el movimiento realizado anteriormente y el 7 la máxima facilidad.
Se realizó una modificación en el MIQ-R.
Los ítems 2 y 5, en los que se realiza un pequeño salto, se cambiaron colocándose de puntillas.
Las consistencias internas del MIQ-R han sido consistentemente adecuadas con coeficientes α de Cronbach que oscilan por encima de 0,84 para la escala total, 0,80 para la subescala visual y 0,84 para la subescala cinestésica.
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Pre-intervención
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Cronometría mental
Periodo de tiempo: Pre-intervención
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También se utilizó la evaluación de la cronometría mental para medir la capacidad de visualización motora del sujeto.
Utilizando un cronómetro, se registró el tiempo empleado para realizar cada tarea MIQ-R.
El tiempo registrado corresponde al intervalo entre la orden de inicio de la tarea, dada por el evaluador, y la respuesta verbal de conclusión de la tarea, dada por el sujeto.
La cronometría mental es una tarea de comportamiento confiable que se ha empleado previamente para recopilar una medida objetiva de la capacidad de MI
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Pre-intervención
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El grado de actividad física
Periodo de tiempo: Pre-intervención
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El grado de actividad física se objetivó a través del cuestionario The International Physical Activity Questionnaire, que permite dividir a los sujetos en tres grupos según su nivel de actividad, que puede ser alto, moderado y bajo o inactivo
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Pre-intervención
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2 (Otro identificador: Instituto Cardiovascular de Buenos Aires)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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