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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06017154
Other study ID # 88851
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 17, 2023
Est. completion date February 5, 2024

Study information

Verified date April 2024
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date February 5, 2024
Est. primary completion date February 5, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Kentucky Lexington Kentucky

Sponsors (1)

Lead Sponsor Collaborator
Ke'La H Porter

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in brain activation 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
Primary Change in functional connectivity 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
Primary Change in reaction time 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
Primary Change in accuracy 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 Demographic/Injury History Form 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
Secondary Defense Veterans Pain Rating Scale 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
Secondary Modified Disablement In Physically Active Scale 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
Secondary NASA Physical Activity Survey 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
Secondary Heart rate 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
Secondary Average reaction time during the intervention Average reaction time in milliseconds will be captured during the exercises via light sensors. 30 minutes, during the training session
Secondary Misses 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
Secondary Hits 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
Secondary Number of errors 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
Secondary Rate of perceived exertion 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
Secondary Perceived cognitive difficulty 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
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