Neuromuscular Cognitive Training (I-THINC)

June 3, 2024 updated by: Ke'La H Porter

Improved Training Happens With Integrated Neuromuscular and Cognitive Challenge

This project will utilize a quasi-experimental, multiple baseline pretest-posttest design where participants will complete postural stability assessments, physical performance assessments, and questionnaires to evaluate perceptions toward injury prevention before and after completing a 6-week neuromuscular-cognitive prevention program.

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.

Detailed Description

The I-THINC program will address aspects of cognition (i.e., reaction time/processing speed, working memory, cognitive flexibility, inhibitory control, attention, and dual-tasking) while completing common movement patterns utilized in tennis (i.e., lateral shuffle, rapid acceleration/deceleration, and postural stability). The proposed program will take place in the participants training facility. The program will be implemented twice per week for six weeks (12 sessions) with each session lasting 20 minutes. To add variety, there will be two complementary programs (A and B) comprising of four exercises increasing in complexity every two weeks. Each week participants will complete Program A during the first session and Program B during the second session.Exercises will progressively challenge cognitive and physical demand. Exercises were designed to address the most common injuries in tennis.

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.
10

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 Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • Sports Medicine Research Institute

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

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • healthy adults from the University of Kentucky varsity tennis programs

Exclusion Criteria:

  • not medically cleared for participation

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: Varsity Athletes
Healthy adults recruited from the University of Kentucky varsity tennis programs.
Other: I-THINC
Improved Training Happens with Integrated Neuromuscular and Cognitive Challenge (I-THINC) is an injury prevention program. It will be used to integrate cognitive tasks with traditional sports injury prevention approaches that focus on balance, agility, and neuromuscular control.

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 single task static postural stability
Time Frame: 6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
Single task static postural stability will be assessed with an Accusway Plus force plate.
6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
Change in dual task postural stability
Time Frame: 6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
Dual task static postural stability will be assessed with an Accusway Plus force plate while completeing an upper extremity reaction time on the Dynavision D2.
6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
Change in dynamic postural control
Time Frame: 6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
Dynamic postural control will be assessed with the single leg hop.
6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
Change in dual task dynamic postural control
Time Frame: 6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
Dynamic postural control will be assessed with the single leg hop. An additional cognitive task - responding to LED color cues - will be added.
6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
Change in speed, power and agility (single measure)
Time Frame: 6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
Speed, power and agility will be measured using the Run Decide Test.
6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
Change in reactive agility
Time Frame: 6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
Reactive agility will be assessed with the 4x4 box drill.
6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
Change in lower extremity reaction time
Time Frame: 6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
Lower extremity reaction time will be assessed with the lower extremity reaction test, deactivating sensors as quickly as possible with their foot.
6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
Change in HBMS
Time Frame: 6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
Health Belief Model Scale (HBMS) is used to assess behavioral determinants of exercise related injury prevention programs and is comprised of six subscales: susceptibility, severity, benefits, barriers, cues to action, and self-efficacy. Participants rate how strongly they agree or disagree with the statements on a Likert scale ranging from 3 to -3, with a 3 indicating strongly agree and -3 indicating strongly disagree. Positive responses indicate a positive perception towards injury prevention programs, except the barrier subscale where positive responses indicate a negative perception towards injury prevention programs.
6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
Participant engagement
Time Frame: at 6 weeks
The participant engagement survey will contain Likert Scale (1-5) questions to provide a quantitative analysis of satisfaction with the program. A 1 indicates strongly disagree and a 5 indicates strongly agree. The range is 7-35, and higher scores indicate increased engagement.
at 6 weeks
Compliance
Time Frame: 6 weeks
Compliance will be based on the percentage of sessions attended by participants.
6 weeks

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 Porter, MS, ATC,CSCS, 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.
August 23, 2022

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.
October 15, 2022

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.
October 15, 2022

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).
July 12, 2022

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.
July 12, 2022

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.
July 15, 2022

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.
June 4, 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.
June 3, 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.
June 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.
  • 76666

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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