<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/NCT03769974</url>
  </required_header>
  <id_info>
    <org_study_id>4</org_study_id>
    <nct_id>NCT03769974</nct_id>
  </id_info>
  <brief_title>Evaluation of Motor Learning on a Sequence of Manual Motor Gestures of Increasing Complexity Through the Mental Practise</brief_title>
  <official_title>Evaluation of Motor Learning on a Sequence of Manual Motor Gestures of Increasing Complexity Through the Action Observation Training and Motor Imagery: a Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Autonoma de Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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 research is to evaluate and quantify successes and errors, as well&#xD;
      as execution time, in a sequence of manual motor gestures of increasing complexity through&#xD;
      mental practice training (observation of actions and motor imagery).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The motor programs stored in the procedural memory systems allow the generation of motor&#xD;
      mental images without the need for an external stimulus, although it has been demonstrated&#xD;
      that providing visual information, prior to a task of imagination, facilitates it and causes&#xD;
      a greater neurophysiological activity than if it were done in an isolated manner. Some&#xD;
      studies have shown that in the short term, in complex motor tasks of foot and hand in a&#xD;
      coordinated manner, the action observation training provokes a greater motor learning&#xD;
      compared to the motor imagery strategy.&#xD;
&#xD;
      However, these studies have only assessed short-term memory immediately after the&#xD;
      intervention. No study has so far evaluated these improvements in motor learning through&#xD;
      action observation training and motor imagery on consecutive days, nor has it been evaluated&#xD;
      with short to medium-term follow-up.&#xD;
&#xD;
      It is therefore that there is a lack in the current scientific literature regarding which&#xD;
      isolated method, without physical practice, of mental practice on motor learning is the most&#xD;
      effective when exposed both on consecutive days, as well as to short-medium-term follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 6, 2018</start_date>
  <completion_date type="Anticipated">August 10, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 10, 2019</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>Double (Participant, Investigator)</masking>
    <masking_description>An independent blind assessor will perform the measurements and recorded the data. Finally, the participants will also be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of successes in finger positions</measure>
    <time_frame>changes in the success rates at the end of the intervention, 7 days, 1 month and 4 months after the end of the intervention</time_frame>
    <description>During the measurements, the percentage of hits and errors achieved in each hand position in each of the manual engine sequences will be evaluated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Execution time</measure>
    <time_frame>changes in the success rates at the end of the intervention, 7 days, 1 month and 4 months after the end of the intervention</time_frame>
    <description>During each measurement, the time required for each participant to place their hands will be recorded.</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>
  <secondary_outcome>
    <measure>Laterality task</measure>
    <time_frame>Pre-intervention</time_frame>
    <description>With the task of recognition of the hand's laterality, two aspects will be evaluated: first, the precision (percentage of correct answers) of the discrimination of the laterality which is the capacity to recognize if a part of the body belongs to the right or left hemicorpse and second, the response time that the participants use in the task of discrimination or cognitive judgment. The app designed and developed by the NOI group will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Memory Operation Questionnaire</measure>
    <time_frame>Pre-intervention</time_frame>
    <description>The allows a cognitive evaluation of everyday memory failures. The questionnaire contains four subscales: daily memory, text recall, past memories and mnemonic strategies. The memory functioning questionnaire has adequate psychometric properties of validity and reliability obtained. An acceptable internal consistency was obtained, with a Cronbach alpha coefficient of the total scale of 0.818 memory operation questionnaire</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Motor Activity</condition>
  <arm_group>
    <arm_group_label>Motor imagery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A group of healthy subjects who meet the inclusion and exclusion criteria established for the study to which a first-person kinesthetic motor imagery training will be conducted on a sequence of manual motor gestures of increasing complexity for four consecutive days. The tasks of motor imagery will be 2 series of 30 seconds for each of the 12 manual positions to remember</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Action observation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A group of healthy subjects who meet the inclusion and exclusion criteria established for the study to which a first-personaction observation training will be conducted on a sequence of manual motor gestures of increasing complexity for four consecutive days. The tasks of action observation will be 2 series of 30 seconds for each of the 12 manual positions to remember in video format.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A group of healthy subjects who meet the inclusion and exclusion criteria established for the study to which an imagery training and placebo observation, inspired by a rural landscape, will be given for four consecutive days. This group will carry out the observation and imagination of a landscape during 2 series of 30 seconds for each manual motor sequence to remember.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motor imagery</intervention_name>
    <description>Two series of 30 seconds training of motor imagery in each manual engine gesture</description>
    <arm_group_label>Motor imagery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Action observation</intervention_name>
    <description>Two series of 30 seconds training of action observation training in video format in each manual engine gesture</description>
    <arm_group_label>Action observation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Placebo intervention</intervention_name>
    <description>Two series of 30 seconds of observation and imagination of a landscape during for each manual motor sequence</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 60&#xD;
&#xD;
          -  Healthy and with no pain subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any cognitive impairment that hindered viewing of audiovisual material. Difficulty&#xD;
             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;
      </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>
  <overall_contact>
    <last_name>Roy La Touche, PhD</last_name>
    <phone>917401980</phone>
    <phone_ext>313</phone_ext>
    <email>roylatouche@lasallecampus.es</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ferran Cuenca-Martínez, MSc</last_name>
    <phone>628936505</phone>
    <email>fecuen2@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CSEU La Salle</name>
      <address>
        <city>Madrid</city>
        <zip>28023</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roy La Touche, physiotherapist</last_name>
      <phone>917401980</phone>
      <phone_ext>313</phone_ext>
      <email>roylatouche@lasallecampus.es</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>March 27, 2019</last_update_submitted>
  <last_update_submitted_qc>March 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2019</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>motor learning</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/NCT03769974
org study id: 4
nct id: NCT03769974
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The main objective of this research is to evaluate and quantify successes and errors, as well
      as execution time, in a sequence of manual motor gestures of increasing complexity through
      mental practice training (observation of actions and motor imagery).
The motor programs stored in the procedural memory systems allow the generation of motor
      mental images without the need for an external stimulus, although it has been demonstrated
      that providing visual information, prior to a task of imagination, facilitates it and causes
      a greater neurophysiological activity than if it were done in an isolated manner. Some
      studies have shown that in the short term, in complex motor tasks of foot and hand in a
      coordinated manner, the action observation training provokes a greater motor learning
      compared to the motor imagery strategy.

      However, these studies have only assessed short-term memory immediately after the
      intervention. No study has so far evaluated these improvements in motor learning through
      action observation training and motor imagery on consecutive days, nor has it been evaluated
      with short to medium-term follow-up.

      It is therefore that there is a lack in the current scientific literature regarding which
      isolated method, without physical practice, of mental practice on motor learning is the most
      effective when exposed both on consecutive days, as well as to short-medium-term follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
masking description: An independent blind assessor will perform the measurements and recorded the data. Finally, the participants will also be blinded.
measure: Percentage of successes in finger positions
time frame: changes in the success rates at the end of the intervention, 7 days, 1 month and 4 months after the end of the intervention
description: During the measurements, the percentage of hits and errors achieved in each hand position in each of the manual engine sequences will be evaluated.
measure: Execution time
time frame: changes in the success rates at the end of the intervention, 7 days, 1 month and 4 months after the end of the intervention
description: During each measurement, the time required for each participant to place their hands will be recorded.
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
measure: Laterality task
time frame: Pre-intervention
description: With the task of recognition of the hand's laterality, two aspects will be evaluated: first, the precision (percentage of correct answers) of the discrimination of the laterality which is the capacity to recognize if a part of the body belongs to the right or left hemicorpse and second, the response time that the participants use in the task of discrimination or cognitive judgment. The app designed and developed by the NOI group will be used.
measure: Memory Operation Questionnaire
time frame: Pre-intervention
description: The allows a cognitive evaluation of everyday memory failures. The questionnaire contains four subscales: daily memory, text recall, past memories and mnemonic strategies. The memory functioning questionnaire has adequate psychometric properties of validity and reliability obtained. An acceptable internal consistency was obtained, with a Cronbach alpha coefficient of the total scale of 0.818 memory operation questionnaire
arm group label: Motor imagery
arm group type: Experimental
description: A group of healthy subjects who meet the inclusion and exclusion criteria established for the study to which a first-person kinesthetic motor imagery training will be conducted on a sequence of manual motor gestures of increasing complexity for four consecutive days. The tasks of motor imagery will be 2 series of 30 seconds for each of the 12 manual positions to remember
arm group label: Action observation
arm group type: Experimental
description: A group of healthy subjects who meet the inclusion and exclusion criteria established for the study to which a first-personaction observation training will be conducted on a sequence of manual motor gestures of increasing complexity for four consecutive days. The tasks of action observation will be 2 series of 30 seconds for each of the 12 manual positions to remember in video format.
arm group label: Placebo group
arm group type: Placebo Comparator
description: A group of healthy subjects who meet the inclusion and exclusion criteria established for the study to which an imagery training and placebo observation, inspired by a rural landscape, will be given for four consecutive days. This group will carry out the observation and imagination of a landscape during 2 series of 30 seconds for each manual motor sequence to remember.
intervention type: Behavioral
intervention name: Motor imagery
description: Two series of 30 seconds training of motor imagery in each manual engine gesture
arm group label: Motor imagery
intervention type: Behavioral
intervention name: Action observation
description: Two series of 30 seconds training of action observation training in video format in each manual engine gesture
arm group label: Action observation
intervention type: Behavioral
intervention name: Placebo intervention
description: Two series of 30 seconds of observation and imagination of a landscape during for each manual motor sequence
arm group label: Placebo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Roy La Touche, PhD
phone: 917401980
phone ext: 313
email: roylatouche@lasallecampus.es
last name: Ferran Cuenca-Martínez, MSc
phone: 628936505
email: fecuen2@gmail.com
facility: 
status: Recruiting
contact: 
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