- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Madrid, Spain, 28023
- CSEU La Salle
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental 1
Motor 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).
|
|
Experimental: Experimental 2
Action 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.
|
|
No Intervention: Control Group
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Electrodermal Activity
Time Frame: Change in electrodermal activity after 5 minutes post-intervention
|
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
|
Change in electrodermal activity after 5 minutes post-intervention
|
|
Respiration Rate
Time Frame: Change in respiration rate after 5 minutes post-intervention
|
Respiration Rate will be measured through a pressure transducer located in the centre of the chest, where it was fixed by a strap
|
Change in respiration rate after 5 minutes post-intervention
|
|
Heart Rate
Time Frame: Change in heart rate after 5 minutes post-intervention
|
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.
|
Change in heart rate after 5 minutes post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual and Kinesthetic Motor Imagery Ability
Time Frame: Pre-intervention
|
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.
|
Pre-intervention
|
|
Mental Chronometry
Time Frame: Pre-intervention
|
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
|
Pre-intervention
|
|
The degree of physical activity
Time Frame: Pre-intervention
|
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
|
Pre-intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2 (Other Identifier: Instituto Cardiovascular de Buenos Aires)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autonomic Nervous System
-
The Hong Kong Polytechnic UniversityUnknownAutonomic Nervous System DisorderChina
-
Northwell HealthEnrolling by invitationAutonomic Nervous System Diseases | Autonomic Dysfunction | Autonomic Imbalance | Vagus Nerve Autonomic DisorderUnited States
-
Istanbul Medipol University HospitalCompletedVagus Nerve Autonomic DisorderTurkey
-
University Health Network, TorontoNot yet recruitingAutonomic Dysfunction
-
Virginia Polytechnic Institute and State UniversityEnrolling by invitation
-
University of Mississippi Medical CenterVicor Technologies, Inc.CompletedAutonomic DysfunctionUnited States
-
Federal University of Health Science of Porto AlegreCompletedVertebra; Degeneration | Other Disorders of the Autonomic Nervous SystemBrazil
-
University of MichiganCompletedAutonomic Peripheral Nervous System DiseasesUnited States
-
National Institute of Neurological Disorders and...Completed
Clinical Trials on Motor Imagery
-
Abant Izzet Baysal UniversityNot yet recruitingCerebral Palsy (CP) | Spasticity | Motor LearningTurkey
-
Abant Izzet Baysal UniversityRecruitingCerebral Palsy, SpasticTurkey
-
Ege UniversityThe Scientific and Technological Research Council of TurkeyCompletedMotor Imagery Training | Virtual Reality | Resistance TrainingTurkey (Türkiye)
-
KTO Karatay UniversityRecruitingPregnancy-related Lumbopelvic PainTurkey (Türkiye)
-
Ahmed Mahmoud KadryConcordia University WisconsinCompleted
-
Universidad Autonoma de MadridCompletedAnalgesia | ExerciseSpain
-
Dr. Mehak NaeemUniversity of Health Sciences LahoreRecruiting
-
Seoul National University Bundang HospitalTerminatedStroke | HemiplegiaKorea, Republic of
-
Green International UniversityCompletedComplex Regional Pain Syndrome (CRPS) | Shoulder Hand SyndromePakistan
-
Universidad Autonoma de MadridCentro Universitario La SalleUnknown