- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05459363
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
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
Interventional
Enrollment (Actual)
10
Phase
- 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 Locations
-
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Kentucky
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Lexington, Kentucky, United States, 40506
- Sports Medicine Research Institute
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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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Varsity Athletes
Healthy adults recruited from the University of Kentucky varsity tennis programs.
|
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
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)
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Single task static postural stability will be assessed with an Accusway Plus force plate.
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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.
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6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
|
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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.
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6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
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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.
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6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
|
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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.
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6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
|
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Change in reactive agility
Time Frame: 6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
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Reactive agility will be assessed with the 4x4 box drill.
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6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
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Change in lower extremity reaction time
Time Frame: 6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
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Lower extremity reaction time will be assessed with the lower extremity reaction test, deactivating sensors as quickly as possible with their foot.
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6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
|
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Change in HBMS
Time Frame: 6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
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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.
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6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
|
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Participant engagement
Time Frame: at 6 weeks
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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.
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at 6 weeks
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Compliance
Time Frame: 6 weeks
|
Compliance will be based on the percentage of sessions attended by participants.
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6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
August 23, 2022
Primary Completion (Actual)
October 15, 2022
Study Completion (Actual)
October 15, 2022
Study Registration Dates
First Submitted
July 12, 2022
First Submitted That Met QC Criteria
July 12, 2022
First Posted (Actual)
July 15, 2022
Study Record Updates
Last Update Posted (Estimated)
June 4, 2024
Last Update Submitted That Met QC Criteria
June 3, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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