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CompletedNCT03232879Updated Mar 1, 2018

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.

An interventional study of Motor Imagery and Action Observation in Autonomic Nervous System, sponsored by Universidad Autonoma de Madrid. Completed at 1 site in Spain. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-01.

Sponsored by Universidad Autonoma de Madrid · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jan 2017, registered Jul 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Autonomic Nervous System

Keywords

  • Motor Imagery
  • Action Observation
  • Heart Rate
  • Respiration Rate
  • Electrodermal Activity
03

In context

Lead sponsor

Universidad Autonoma de Madrid is the lead sponsor of 51 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Experimental 1

    Motor Imagery

    Behavioral: Motor Imagery

  • Experimental
    Experimental 2

    Action Observation

    Behavioral: Action Observation

  • No intervention
    Control Group

    No intervention

Interventions

  • BehavioralMotor Imagery

    Two consecutive 30 seconds imagery tasks were performed, both based on two movements that are recorded in the Revised Movement Imagery Questionnaire (MIQ-R).

  • BehavioralAction Observation

    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.

06

What researchers measure

Primary outcomes

  1. Electrodermal Activity

    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

    Time frame: Change in electrodermal activity after 5 minutes post-intervention

  2. Respiration Rate

    Respiration Rate will be measured through a pressure transducer located in the centre of the chest, where it was fixed by a strap

    Time frame: Change in respiration rate after 5 minutes post-intervention

  3. Heart Rate

    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.

    Time frame: Change in heart rate after 5 minutes post-intervention

Secondary outcomes

  1. Visual and Kinesthetic Motor Imagery Ability

    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.

    Time frame: Pre-intervention

  2. Mental Chronometry

    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

    Time frame: Pre-intervention

  3. The degree of physical activity

    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

    Time frame: Pre-intervention

07

Study locations

1 site
  • CSEU La Salle
    Madrid, 28023, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2017 to primary completion in Apr 2017, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 24, 2017
First posted
Jul 28, 2017
StartActual
Jan 30, 2017
Primary completionActual
Apr 10, 2017
CompletionActual
Jun 30, 2017
Last update
Mar 1, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03232879
Lead sponsor
Universidad Autonoma de Madrid
Collaborators
Centro Universitario La Salle
Responsible party
Roy La Touche Arbizu (Principal Investigator, Universidad Autonoma de Madrid) — Principal investigator
First posted
Jul 28, 2017
Start date
Jan 30, 2017
Primary completion
Apr 10, 2017
Completion
Jun 30, 2017
Last update
Mar 1, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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