xml: <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/NCT06017154</url>
    </required_header>
    <id_info>
      <org_study_id>88851</org_study_id>
      <nct_id>NCT06017154</nct_id>
    </id_info>
    <brief_title>Acute Effect of Motor-Cognitive Training</brief_title>
    <official_title>The Acute Effects of Brain Activation and Functional Connectivity Following Motor-cognitive Training Using Functional MRI</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ke'La H Porter</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Kentucky</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Participants will complete a functional MRI to evaluate brain activation, functional&#xD;
        connectivity, and behavioral performance immediately before and after a training program&#xD;
        (approximately 30 minutes). The training program will comprise of integrate neuromuscular&#xD;
        (agility, dynamic postural stability, shuffling, rapid acceleration/deceleration,&#xD;
        plyometrics, lateral shuffle, and core stability) and cognitive (reaction time, processing&#xD;
        speed, task switching, decision-making, and working memory) challenges.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in brain activation</measure>
      <time_frame>2 hours, pre-training session and immediately post-training session</time_frame>
      <description>During the task-based functional MRI scan the participant will complete a task-switching cognitive task, where participants have to identify two possible shapes (circle or square), in one of two possible colors (red or blue). They will respond using a trigger under their left and right foot. The level of brain activation during the task will be captured and reported.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in functional connectivity</measure>
      <time_frame>2 hours, pre-training session and immediately post-training session</time_frame>
      <description>The participant will complete a resting-state functional MRI scan in which they will lay still in the scanner. No task is performed during this scan. Functional connectivity (functionally related regions of the brain that are co-activated) during the scan will be captured and reported.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in reaction time</measure>
      <time_frame>2 hours, pre-training session and immediately post-training session</time_frame>
      <description>During the task-based functional MRI scan the participant will complete a task-switching cognitive task, where participants have to identify two possible shapes (circle or square), in one of two possible colors (red or blue). They will respond using a trigger under their left and right foot. The reaction time in milliseconds will be captured. The change in reaction time from pre to post training session will be reported.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in accuracy</measure>
      <time_frame>2 hours, pre-training session and immediately post-training session</time_frame>
      <description>During the task-based functional MRI scan the participant will complete a task-switching cognitive task, where participants have to identify two possible shapes (circle or square), in one of two possible colors (red or blue). They will respond using a trigger under their left and right foot. The percent of correct responses (accuracy) will be captured. The change in accuracy from pre to post training session will be reported.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Demographic/Injury History Form</measure>
      <time_frame>Once, pre-training</time_frame>
      <description>The demographic and injury history form is designed to capture: 1) information about the participant including age, height, weight, race, ethnicity, 2) information related to sports participation, and 3) information related to past injuries or medical conditions which are relevant to the study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Defense Veterans Pain Rating Scale</measure>
      <time_frame>Once, pre-training</time_frame>
      <description>The Defense Veterans Pain Rating Scale is a valid 5-item scale to assess pain magnitude and pain interference. This scale ranges from 0 to 10, 0 indicating no pain/interference and 10 indicating as bas as it could be/complete interference.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified Disablement In Physically Active Scale</measure>
      <time_frame>Once, pre-training</time_frame>
      <description>16-item patient-reported outcome instrument that assesses physical and psychosocial status.This scale ranges from 0 to 4, 0 indicating no problem and 4 indicating severe.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>NASA Physical Activity Survey</measure>
      <time_frame>Once, pre-training</time_frame>
      <description>This survey asks individuals to self-report their general physical activity over the past week. This survey ranges from 0 to 10, 0 indicating sedentary and 10 indicating high physical activity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart rate</measure>
      <time_frame>35 minutes, during the training session</time_frame>
      <description>Heart rate will be monitored with a noninvasive heart rate monitor that will be worn by the participant around the chest at the level of the xiphoid process. Resting heart rate will be collected prior to the start intervention then monitored and recorded throughout the training session.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average reaction time during the intervention</measure>
      <time_frame>30 minutes, during the training session</time_frame>
      <description>Average reaction time in milliseconds will be captured during the exercises via light sensors.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Misses during the training session</measure>
      <time_frame>30 minutes, during the training session</time_frame>
      <description>The number of misses will be captured during the exercises via light sensors. A miss is considered when they deactivate the wrong sensor or don't deactivate the sensor quickly enough.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hits during the training session</measure>
      <time_frame>30 minutes, during the training session</time_frame>
      <description>The number of hits will be captured during the exercises via light sensors. A hit is considered when they deactivate the correct sensor.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of errors during the training session</measure>
      <time_frame>30 minutes, during the training session</time_frame>
      <description>The number of errors will be captured during the exercises by visual observation. An error occurs when they do not complete they exercise correctly.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of perceived exertion</measure>
      <time_frame>30 minutes, during the training session</time_frame>
      <description>After each exercise the participant will be asked to rate their perceived exertion on a scale from 6 to 20, 6 indicating low perceived exertion and 20 indicating high perceived exertion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived cognitive difficulty</measure>
      <time_frame>30 minutes, during the training session</time_frame>
      <description>After each exercise the participant will be asked to rate their perceived cognitive difficulty on a scale from 1 to 10, 1 indicating low cognitive challenge and 10 indicating high cognitive challenge</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Injury;Sports</condition>
    <arm_group>
      <arm_group_label>Physically active females</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Healthy active females between 18 and 25</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Motor-Cognitive Training Program</intervention_name>
      <description>The training will incorporate cognitive tasks which focus on reaction time, processing speed, working memory, cognitive flexibility, and inhibitory control using visual stimuli on a screen or through sensors which illuminate using LED lights. These cognitive tasks will be performed while also executing physical performance tasks that challenge static and dynamic postural stability, lateral movement, agility, and other movement patterns. The training session will last approximately 30 minutes and participants will complete up to 5 exercises</description>
      <arm_group_label>Physically active females</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Physically active&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Injury to the muscle or bone (upper extremity, lower extremity, or back) within the&#xD;
               past 3 months&#xD;
  &#xD;
            -  Had musculoskeletal surgery or fracture (required open reduction internal fixation or&#xD;
               within the last 12 months)&#xD;
  &#xD;
            -  Had a concussion or mild head injury within the last year&#xD;
  &#xD;
            -  Have been diagnosed with any kind of neurological, vestibular, or visual disturbance&#xD;
               that impairs mobility&#xD;
  &#xD;
            -  Currently taking medications that affect the central nervous system&#xD;
  &#xD;
            -  Pregnant or suspicions of being pregnant&#xD;
  &#xD;
            -  Have metal fragments, pins, plates, or clips, shrapnel, body piercings that cannot be&#xD;
               removed, have surgical implants or orthodontics that cannot be removed&#xD;
  &#xD;
            -  Have claustrophobia&#xD;
  &#xD;
            -  Have a history of cognitive impairment&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ke'La H Porter, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Kentucky</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ke'La H Porter, MS</last_name>
      <phone>859-323-9850</phone>
      <email>kela.porter@uky.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Matthew C Hoch, PhD</last_name>
      <email>matt.hoch@uky.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Kentucky</name>
        <address>
          <city>Lexington</city>
          <state>Kentucky</state>
          <zip>40506</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Ke'La Porter, MS</last_name>
        <phone>859-323-9850</phone>
        <email>kela.porter@uky.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Kentucky</investigator_affiliation>
      <investigator_full_name>Ke'La H Porter</investigator_full_name>
      <investigator_title>Research Analyst Principal</investigator_title>
    </responsible_party>
    <keyword>injury prevention</keyword>
    <keyword>cognition</keyword>
    <keyword>physical performance</keyword>
    <keyword>athletic training</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Athletic Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06017154
  org study id: 88851
  nct id: NCT06017154
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Participants will complete a functional MRI to evaluate brain activation, functional
        connectivity, and behavioral performance immediately before and after a training program
        (approximately 30 minutes). The training program will comprise of integrate neuromuscular
        (agility, dynamic postural stability, shuffling, rapid acceleration/deceleration,
        plyometrics, lateral shuffle, and core stability) and cognitive (reaction time, processing
        speed, task switching, decision-making, and working memory) challenges.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Change in brain activation
  time frame: 2 hours, pre-training session and immediately post-training session
  description: During the task-based functional MRI scan the participant will complete a task-switching cognitive task, where participants have to identify two possible shapes (circle or square), in one of two possible colors (red or blue). They will respond using a trigger under their left and right foot. The level of brain activation during the task will be captured and reported.
  measure: Change in functional connectivity
  time frame: 2 hours, pre-training session and immediately post-training session
  description: The participant will complete a resting-state functional MRI scan in which they will lay still in the scanner. No task is performed during this scan. Functional connectivity (functionally related regions of the brain that are co-activated) during the scan will be captured and reported.
  measure: Change in reaction time
  time frame: 2 hours, pre-training session and immediately post-training session
  description: During the task-based functional MRI scan the participant will complete a task-switching cognitive task, where participants have to identify two possible shapes (circle or square), in one of two possible colors (red or blue). They will respond using a trigger under their left and right foot. The reaction time in milliseconds will be captured. The change in reaction time from pre to post training session will be reported.
  measure: Change in accuracy
  time frame: 2 hours, pre-training session and immediately post-training session
  description: During the task-based functional MRI scan the participant will complete a task-switching cognitive task, where participants have to identify two possible shapes (circle or square), in one of two possible colors (red or blue). They will respond using a trigger under their left and right foot. The percent of correct responses (accuracy) will be captured. The change in accuracy from pre to post training session will be reported.
  measure: Demographic/Injury History Form
  time frame: Once, pre-training
  description: The demographic and injury history form is designed to capture: 1) information about the participant including age, height, weight, race, ethnicity, 2) information related to sports participation, and 3) information related to past injuries or medical conditions which are relevant to the study.
  measure: Defense Veterans Pain Rating Scale
  time frame: Once, pre-training
  description: The Defense Veterans Pain Rating Scale is a valid 5-item scale to assess pain magnitude and pain interference. This scale ranges from 0 to 10, 0 indicating no pain/interference and 10 indicating as bas as it could be/complete interference.
  measure: Modified Disablement In Physically Active Scale
  time frame: Once, pre-training
  description: 16-item patient-reported outcome instrument that assesses physical and psychosocial status.This scale ranges from 0 to 4, 0 indicating no problem and 4 indicating severe.
  measure: NASA Physical Activity Survey
  time frame: Once, pre-training
  description: This survey asks individuals to self-report their general physical activity over the past week. This survey ranges from 0 to 10, 0 indicating sedentary and 10 indicating high physical activity.
  measure: Heart rate
  time frame: 35 minutes, during the training session
  description: Heart rate will be monitored with a noninvasive heart rate monitor that will be worn by the participant around the chest at the level of the xiphoid process. Resting heart rate will be collected prior to the start intervention then monitored and recorded throughout the training session.
  measure: Average reaction time during the intervention
  time frame: 30 minutes, during the training session
  description: Average reaction time in milliseconds will be captured during the exercises via light sensors.
  measure: Misses during the training session
  time frame: 30 minutes, during the training session
  description: The number of misses will be captured during the exercises via light sensors. A miss is considered when they deactivate the wrong sensor or don't deactivate the sensor quickly enough.
  measure: Hits during the training session
  time frame: 30 minutes, during the training session
  description: The number of hits will be captured during the exercises via light sensors. A hit is considered when they deactivate the correct sensor.
  measure: Number of errors during the training session
  time frame: 30 minutes, during the training session
  description: The number of errors will be captured during the exercises by visual observation. An error occurs when they do not complete they exercise correctly.
  measure: Rate of perceived exertion
  time frame: 30 minutes, during the training session
  description: After each exercise the participant will be asked to rate their perceived exertion on a scale from 6 to 20, 6 indicating low perceived exertion and 20 indicating high perceived exertion
  measure: Perceived cognitive difficulty
  time frame: 30 minutes, during the training session
  description: After each exercise the participant will be asked to rate their perceived cognitive difficulty on a scale from 1 to 10, 1 indicating low cognitive challenge and 10 indicating high cognitive challenge
  arm group label: Physically active females
  arm group type: Experimental
  description: Healthy active females between 18 and 25
  intervention type: Other
  intervention name: Motor-Cognitive Training Program
  description: The training will incorporate cognitive tasks which focus on reaction time, processing speed, working memory, cognitive flexibility, and inhibitory control using visual stimuli on a screen or through sensors which illuminate using LED lights. These cognitive tasks will be performed while also executing physical performance tasks that challenge static and dynamic postural stability, lateral movement, agility, and other movement patterns. The training session will last approximately 30 minutes and participants will complete up to 5 exercises
  arm group label: Physically active females
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 25 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ke'La H Porter, MS
  role: Principal Investigator
  affiliation: University of Kentucky
  last name: Ke'La H Porter, MS
  phone: 859-323-9850
  email: kela.porter@uky.edu
  last name: Matthew C Hoch, PhD
  email: matt.hoch@uky.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Kentucky
  investigator full name: Ke'La H Porter
  investigator title: Research Analyst Principal
  mesh term: Athletic Injuries
  sharing ipd: No