Injury;SportsI-THINCNCT05459363
Neuromuscular Cognitive Training
A study testing I-THINC in people with Injury;Sports, run by Ke'La H Porter at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Injury;Sports
- What is being tested?
- I-THINC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2022to 15 Oct 2022
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy adults from the University of Kentucky varsity tennis programs
Who cannot join
- not medically cleared for participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Sports Medicine Research Institute
Lexington, Kentucky, 40506
About this study
Official title: 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.
Read the 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.
- Conditions
- Injury;Sports
- Being tested
- I-THINC
- Keywords
- injury prevention, cognition, physical performance, postural stability, neuromuscular
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-THINCOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Varsity Athletes | Experimental | Healthy adults recruited from the University of Kentucky varsity tennis programs. Receives: Other: I-THINC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in single task static postural stability
Single task static postural stability will be assessed with an Accusway Plus force plate.
Measured: 6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
Change in dual task postural stability
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.
Measured: 6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
Change in dynamic postural control
Dynamic postural control will be assessed with the single leg hop.
Measured: 6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
Change in dual task dynamic postural control
Dynamic postural control will be assessed with the single leg hop. An additional cognitive task - responding to LED color cues - will be added.
Measured: 6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
Change in speed, power and agility (single measure)
Speed, power and agility will be measured using the Run Decide Test.
Measured: 6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
Change in reactive agility
Reactive agility will be assessed with the 4x4 box drill.
Measured: 6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
Change in lower extremity reaction time
Lower extremity reaction time will be assessed with the lower extremity reaction test, deactivating sensors as quickly as possible with their foot.
Measured: 6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
Change in HBMS
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.
Measured: 6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)
Participant engagement
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.
Measured: at 6 weeks
Compliance
Compliance will be based on the percentage of sessions attended by participants.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start23 Aug 2022
- Primary completion15 Oct 2022
- Study completion15 Oct 2022
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
- 10 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 Porter, MS, ATC,CSCS, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459363
- Sponsor's protocol ID
- 76666
- Acronym
- I-THINC
- Status last verified
- Jun 2024
- First submitted
- 12 Jul 2022
- Last updated
- 4 Jun 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 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Training Happens With Integrated Neuromuscular and Cognitive Challenge
- ClinicalTrials.gov ID
- NCT05459363
- Acronym / sponsor ID
- I-THINC / 76666
- Conditions
- Injury;Sports
- Keywords
- injury prevention, cognition, physical performance, postural stability, neuromuscular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ke'La H PorterUniversity, hospital or other
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 15 Jul 2022 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Varsity Athletes | Experimental | Other: I-THINCHealthy adults recruited from the University of Kentucky varsity tennis programs. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy adults from the University of Kentucky varsity tennis programs
Key exclusion criteria (1 listed)
- not medically cleared for participation
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 |
|---|---|---|
| I-THINCImproved 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. | Other | Varsity Athletes |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
Compliance
Time frame: 6 weeks
Compliance will be based on the percentage of sessions attended by participants.
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 4 Jun 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 Porter, MS, ATC,CSCS 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 I-THINC 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 1 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 4 Jun 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 single task static postural stability (time frame: 6 weeks (baseline, one week after baseline, and immediately following the 6 week intervention)). The study lists 10 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 4 Jun 2024.