NCT05459363

Brief 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 prevention program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

August 23, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2022

Completed
Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

July 12, 2022

Last Update Submit

June 3, 2024

Conditions

Keywords

injury preventioncognitionphysical performancepostural stabilityneuromuscular

Outcome Measures

Primary Outcomes (10)

  • Change in single task static postural stability

    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

    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

    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

    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)

    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

    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

    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

    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

    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

    Compliance will be based on the percentage of sessions attended by participants.

    6 weeks

Study Arms (1)

Varsity Athletes

EXPERIMENTAL

Healthy adults recruited from the University of Kentucky varsity tennis programs.

Other: I-THINC

Interventions

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.

Varsity Athletes

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy adults from the University of Kentucky varsity tennis programs

You may not qualify if:

  • not medically cleared for participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sports Medicine Research Institute

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Athletic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Ke'La Porter, MS, ATC,CSCS

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

July 12, 2022

First Posted

July 15, 2022

Study Start

August 23, 2022

Primary Completion

October 15, 2022

Study Completion

October 15, 2022

Last Updated

June 4, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations