Acute Effect of Motor-Cognitive Training

April 11, 2024 updated by: Ke'La H Porter

The Acute Effects of Brain Activation and Functional Connectivity Following Motor-cognitive Training Using Functional MRI

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • University of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Physically active

Exclusion Criteria:

  • Injury to the muscle or bone (upper extremity, lower extremity, or back) within the past 3 months
  • Had musculoskeletal surgery or fracture (required open reduction internal fixation or within the last 12 months)
  • Had a concussion or mild head injury within the last year
  • Have been diagnosed with any kind of neurological, vestibular, or visual disturbance that impairs mobility
  • Currently taking medications that affect the central nervous system
  • Pregnant or suspicions of being pregnant
  • Have metal fragments, pins, plates, or clips, shrapnel, body piercings that cannot be removed, have surgical implants or orthodontics that cannot be removed
  • Have claustrophobia
  • Have a history of cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Physically active females
Healthy active females between 18 and 25
Other: Motor-Cognitive Training Program
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in brain activation
Time Frame: 2 hours, pre-training session and immediately post-training session
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.
2 hours, pre-training session and immediately post-training session
Change in functional connectivity
Time Frame: 2 hours, pre-training session and immediately post-training session
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.
2 hours, pre-training session and immediately post-training session
Change in reaction time
Time Frame: 2 hours, pre-training session and immediately post-training session
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.
2 hours, pre-training session and immediately post-training session
Change in accuracy
Time Frame: 2 hours, pre-training session and immediately post-training session
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.
2 hours, pre-training session and immediately post-training session

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Demographic/Injury History Form
Time Frame: Once, pre-training
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.
Once, pre-training
Defense Veterans Pain Rating Scale
Time Frame: Once, pre-training
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.
Once, pre-training
Modified Disablement In Physically Active Scale
Time Frame: Once, pre-training
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.
Once, pre-training
NASA Physical Activity Survey
Time Frame: Once, pre-training
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.
Once, pre-training
Heart rate
Time Frame: 35 minutes, during the training session
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.
35 minutes, during the training session
Average reaction time during the intervention
Time Frame: 30 minutes, during the training session
Average reaction time in milliseconds will be captured during the exercises via light sensors.
30 minutes, during the training session
Misses during the training session
Time Frame: 30 minutes, during the training session
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.
30 minutes, during the training session
Hits during the training session
Time Frame: 30 minutes, during the training session
The number of hits will be captured during the exercises via light sensors. A hit is considered when they deactivate the correct sensor.
30 minutes, during the training session
Number of errors during the training session
Time Frame: 30 minutes, during the training session
The number of errors will be captured during the exercises by visual observation. An error occurs when they do not complete they exercise correctly.
30 minutes, during the training session
Rate of perceived exertion
Time Frame: 30 minutes, during the training session
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
30 minutes, during the training session
Perceived cognitive difficulty
Time Frame: 30 minutes, during the training session
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
30 minutes, during the training session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ke'La H Porter

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ke'La H Porter, MS, University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 17, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 5, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 88851

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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