Injury;SportsNCT06017154
Acute Effect of Motor-Cognitive Training
A study testing Motor-Cognitive Training Program in people with Injury;Sports, run by Ke'La H Porter at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Injury;Sports
- What is being tested?
- Motor-Cognitive Training Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2023to 5 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physically active
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Injury;Sports
- Being tested
- Motor-Cognitive Training Program
- Keywords
- injury prevention, cognition, physical performance, athletic training
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor-Cognitive Training ProgramOther
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
| Study group | Role | What they receive |
|---|---|---|
| Physically active females | Experimental | Healthy active females between 18 and 25 Receives: Other: Motor-Cognitive Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours, pre-training session and immediately post-training session
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.
Measured: 2 hours, pre-training session and immediately post-training session
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.
Measured: 2 hours, pre-training session and immediately post-training session
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.
Measured: 2 hours, pre-training session and immediately post-training session
Secondary outcomes (11)
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.
Measured: Once, pre-training
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.
Measured: Once, pre-training
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.
Measured: Once, pre-training
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.
Measured: Once, pre-training
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.
Measured: 35 minutes, during the training session
Average reaction time during the intervention
Average reaction time in milliseconds will be captured during the exercises via light sensors.
Measured: 30 minutes, during the training session
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.
Measured: 30 minutes, during the training session
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.
Measured: 30 minutes, during the training session
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.
Measured: 30 minutes, during the training session
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
Measured: 30 minutes, during the training session
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
Measured: 30 minutes, during the training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start17 Sep 2023
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury;SportsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ke'La H Porter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ke'La H Porter, University of Kentucky
- Investigators
- Ke'La H Porter, MS, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017154
- Sponsor's protocol ID
- 88851
- Status last verified
- Apr 2024
- First submitted
- 18 Aug 2023
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Brain Activation and Functional Connectivity Following Motor-cognitive Training Using Functional MRI
- ClinicalTrials.gov ID
- NCT06017154
- Acronym / sponsor ID
- 88851
- Conditions
- Injury;Sports
- Keywords
- injury prevention, cognition, physical performance, athletic training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ke'La H PorterUniversity, hospital or other
- Study start
- 17 Sep 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physically active females | Experimental | Other: Motor-Cognitive Training ProgramHealthy active females between 18 and 25 |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Physically active
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor-Cognitive Training ProgramThe 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 | Other | Physically active females |
Primary outcome
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.
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.
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.
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.
11 secondary outcomes
Demographic/Injury History Form
Time frame: Once, pre-training
Defense Veterans Pain Rating Scale
Time frame: Once, pre-training
Modified Disablement In Physically Active Scale
Time frame: Once, pre-training
NASA Physical Activity Survey
Time frame: Once, pre-training
Heart rate
Time frame: 35 minutes, during the training session
Average reaction time during the intervention
Time frame: 30 minutes, during the training session
Misses during the training session
Time frame: 30 minutes, during the training session
Hits during the training session
Time frame: 30 minutes, during the training session
Number of errors during the training session
Time frame: 30 minutes, during the training session
Rate of perceived exertion
Time frame: 30 minutes, during the training session
Perceived cognitive difficulty
Time frame: 30 minutes, during the training session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ke'La H Porter, MS principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor-Cognitive Training Program in people with Injury;Sports, run by Ke'La H Porter at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in brain activation (time frame: 2 hours, pre-training session and immediately post-training session). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.