<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03232879</url>
  </required_header>
  <id_info>
    <org_study_id>2</org_study_id>
    <nct_id>NCT03232879</nct_id>
  </id_info>
  <brief_title>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.</brief_title>
  <official_title>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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Autonoma de Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centro Universitario La Salle</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad Autonoma de Madrid</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this study was to compare the activation of the Sympathetic Nervous&#xD;
      System in a program that combined Motor Imagery with Action Observation, in contrast to an&#xD;
      isolated Motor Imagery program on the one hand in asymptomatic subjects and in the other hand&#xD;
      in patients with chronic low back pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Motor Imagery (MI) is defined as a dynamic mental process that involves the representation of&#xD;
      an action, in an internal way, without its actual motor execution. The Action Observation&#xD;
      (AO) evokes an internal, real-time motor simulation of the movements that the observer is&#xD;
      perceiving visually. Both mental processes trigger the activation of the neurocognitive&#xD;
      mechanisms that underlie the planning and execution of voluntary movements in a manner that&#xD;
      resembles how the action is performed in a real manner.&#xD;
&#xD;
      Both observation and imagination share a great number of common mental processes based&#xD;
      primarily on sensory perception, and the information stored by memory systems. The activation&#xD;
      of the motor command during a mental practice does not induce an active movement probably due&#xD;
      to an inhibitory mechanism in the primary motor cortex on the descending corticospinal tract&#xD;
      pathways. However, this inhibition is not complete, for it is well known that the training of&#xD;
      mental practice involves a component of the autonomic nervous system (ANS).&#xD;
&#xD;
      It has been shown that both MI and AO lead to changes in the ANS that cause excitatory&#xD;
      sympathetic responses, although the neurophysiological bases remain uncertain and are still&#xD;
      based on hypotheses. The functional relations between both neurocognitive processes and the&#xD;
      sympathetic-excitatory nervous system (SNS) could be based on a preparation phase in which,&#xD;
      the activation of the SNS, happens to a near effort and, therefore, to a close energy&#xD;
      expenditure in physiological processes (i.e., cardiorespiratory adaptationse) which will take&#xD;
      place in order to face said metabolic changes produced by the voluntary movement itself. In&#xD;
      addition, several hypotheses have been described regarding the notion that the SNS not only&#xD;
      has the quantitative objective of providing energy to the muscle effectors, but that it also&#xD;
      qualitatively and specifically designs and adapts the parameters on demand in an attempt to&#xD;
      save the energy provided for each precise motor execution.&#xD;
&#xD;
      Taking into account that both MI and AO cause sympathetic-excitatory changes that induce an&#xD;
      increase in heart rate, blood pressure, respiratory rate, electrodermal activity , our&#xD;
      hypothesis is that the combination of MI and AO induces an autonomic sympathetic-excitatory&#xD;
      shift greater than MI does in isolation. Therefore, the main objective of this study was to&#xD;
      compare the results obtained from intervention groups on the subject of the activation of the&#xD;
      SNS in a program that combined MI with AO, in contrast to an isolated MI program on the one&#xD;
      hand in asymptomatic subjects and in the other hand in patients with chronic low back pain..&#xD;
      The secondary objective of the present study was to explore whether there is any relationship&#xD;
      between the sympathetic-excitatory response and the ability to generate motor imagery, the&#xD;
      mental chronometry, and the level of physical activity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2017</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">April 10, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Electrodermal Activity</measure>
    <time_frame>Change in electrodermal activity after 5 minutes post-intervention</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiration Rate</measure>
    <time_frame>Change in respiration rate after 5 minutes post-intervention</time_frame>
    <description>Respiration Rate will be measured through a pressure transducer located in the centre of the chest, where it was fixed by a strap</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>Change in heart rate after 5 minutes post-intervention</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual and Kinesthetic Motor Imagery Ability</measure>
    <time_frame>Pre-intervention</time_frame>
    <description>Visual and Kinesthetic Motor Imagery Ability will be measured with MIQ-R Questionnaire. MIQ-R has 4 movements repeated in two subscales, a visual and a kinaesthetic one. Additionally, a score between 1 and 7 is assigned, with 1 representing difficulty in picturing the motor image or difficulty in feeling the movement previously made, and 7 representing the maximum ease. A modification was made in the MIQ-R. Items 2 and 5, in which a small jump is made, were changed by standing on tiptoe. The internal consistencies of the MIQ-R have been consistently adequate with Cronbach's α coefficients ranging above 0.84 for the total scale, 0.80 for de visual subscale and 0.84 for the kinesthetic subscale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental Chronometry</measure>
    <time_frame>Pre-intervention</time_frame>
    <description>Mental chronometry evaluation was also used to measure the subject's motor imagery ability. Using a stopwatch, the time spent for performing each MIQ-R task was recorded. Time recorded corresponds to the interval between the command to start the task, given by the evaluator, and the verbal response of conclusion of the task, given by the subject. Mental chronometry is a reliable behavioral task that has previously been employed to collect an objective measure of MI ability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The degree of physical activity</measure>
    <time_frame>Pre-intervention</time_frame>
    <description>The degree of physical activity was objectified through the The International Physical Activity Questionnaire questionnaire, which allows the subjects to be divided into three groups according to their level of activity, which can be high, moderate, and low or inactive</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Autonomic Nervous System</condition>
  <arm_group>
    <arm_group_label>Experimental 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Motor Imagery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Action Observation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motor Imagery</intervention_name>
    <description>Two consecutive 30 seconds imagery tasks were performed, both based on two movements that are recorded in the Revised Movement Imagery Questionnaire (MIQ-R).</description>
    <arm_group_label>Experimental 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Action Observation</intervention_name>
    <description>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.</description>
    <arm_group_label>Experimental 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria asymptomatic subjects:&#xD;
&#xD;
          -  Age between 18 and 60&#xD;
&#xD;
          -  Healthy and with no pain subjects&#xD;
&#xD;
        Inclusion Criteria patients with chronic low back pain:&#xD;
&#xD;
          -  Low back pain for at least the prior 3 months&#xD;
&#xD;
          -  Low back pain of nonspecific nature&#xD;
&#xD;
          -  Age between 18 and 60&#xD;
&#xD;
          -  Low back pain for at least 10 days per month&#xD;
&#xD;
          -  Intensity of pain of between 3 and 10 on the Visual Analogue Scale&#xD;
&#xD;
        Exclusion Criteria asymptomatic subjects:&#xD;
&#xD;
          -  Any cognitive impairment that hindered viewing of audiovisual material.&#xD;
&#xD;
          -  Difficulty understanding or communicating.&#xD;
&#xD;
          -  Presence of systemic pathology, Central Nervous System or rheumatic disease.&#xD;
&#xD;
          -  Inadequate understanding of the Spanish language to follow instructions for measuring&#xD;
             and treatment.&#xD;
&#xD;
          -  Collaboration of pregnant women.&#xD;
&#xD;
          -  Underage subjects&#xD;
&#xD;
          -  Subjects with pain at the time of the study.&#xD;
&#xD;
        Exclusion Criteria patients with chronic low back pain:&#xD;
&#xD;
          -  Any cognitive impairment that hindered viewing of audiovisual material.&#xD;
&#xD;
          -  Difficulty understanding or communicating.&#xD;
&#xD;
          -  Presence of systemic pathology, Central Nervous System or rheumatic disease.&#xD;
&#xD;
          -  Inadequate understanding of the Spanish language to follow instructions for measuring&#xD;
             and treatment.&#xD;
&#xD;
          -  Collaboration of pregnant women.&#xD;
&#xD;
          -  Underage subjects&#xD;
&#xD;
          -  Having undergone back surgery&#xD;
&#xD;
          -  Specific spinal pathology&#xD;
&#xD;
          -  Recent trauma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CSEU La Salle</name>
      <address>
        <city>Madrid</city>
        <zip>28023</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>February 28, 2018</last_update_submitted>
  <last_update_submitted_qc>February 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Autonoma de Madrid</investigator_affiliation>
    <investigator_full_name>Roy La Touche Arbizu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Motor Imagery</keyword>
  <keyword>Action Observation</keyword>
  <keyword>Heart Rate</keyword>
  <keyword>Respiration Rate</keyword>
  <keyword>Electrodermal Activity</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03232879
org study id: 2
nct id: NCT03232879
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The main objective of this study was to compare the activation of the Sympathetic Nervous
      System in a program that combined Motor Imagery with Action Observation, in contrast to an
      isolated Motor Imagery program on the one hand in asymptomatic subjects and in the other hand
      in patients with chronic low back pain.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Electrodermal Activity
time frame: Change in electrodermal activity after 5 minutes post-intervention
description: 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
measure: Respiration Rate
time frame: Change in respiration rate after 5 minutes post-intervention
description: Respiration Rate will be measured through a pressure transducer located in the centre of the chest, where it was fixed by a strap
measure: Heart Rate
time frame: Change in heart rate after 5 minutes post-intervention
description: 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.
measure: Visual and Kinesthetic Motor Imagery Ability
time frame: Pre-intervention
description: Visual and Kinesthetic Motor Imagery Ability will be measured with MIQ-R Questionnaire. MIQ-R has 4 movements repeated in two subscales, a visual and a kinaesthetic one. Additionally, a score between 1 and 7 is assigned, with 1 representing difficulty in picturing the motor image or difficulty in feeling the movement previously made, and 7 representing the maximum ease. A modification was made in the MIQ-R. Items 2 and 5, in which a small jump is made, were changed by standing on tiptoe. The internal consistencies of the MIQ-R have been consistently adequate with Cronbach's α coefficients ranging above 0.84 for the total scale, 0.80 for de visual subscale and 0.84 for the kinesthetic subscale.
measure: Mental Chronometry
time frame: Pre-intervention
description: Mental chronometry evaluation was also used to measure the subject's motor imagery ability. Using a stopwatch, the time spent for performing each MIQ-R task was recorded. Time recorded corresponds to the interval between the command to start the task, given by the evaluator, and the verbal response of conclusion of the task, given by the subject. Mental chronometry is a reliable behavioral task that has previously been employed to collect an objective measure of MI ability
measure: The degree of physical activity
time frame: Pre-intervention
description: The degree of physical activity was objectified through the The International Physical Activity Questionnaire questionnaire, which allows the subjects to be divided into three groups according to their level of activity, which can be high, moderate, and low or inactive
arm group label: Experimental 1
arm group type: Experimental
description: Motor Imagery
arm group label: Experimental 2
arm group type: Experimental
description: Action Observation
arm group label: Control Group
arm group type: No Intervention
description: No intervention
intervention type: Behavioral
intervention name: Motor Imagery
description: Two consecutive 30 seconds imagery tasks were performed, both based on two movements that are recorded in the Revised Movement Imagery Questionnaire (MIQ-R).
arm group label: Experimental 1
intervention type: Behavioral
intervention name: Action Observation
description: 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.
arm group label: Experimental 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Autonoma de Madrid
investigator full name: Roy La Touche Arbizu
investigator title: Principal Investigator
sharing ipd: No