- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04095260
Identification of Neuromusculoskeletal Variables Associated With Injury Risk and Performance in High School Athletes.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study involves a test - re-test design. Subjects will be tested in their physical performance. These measures include a general assessment of joint mobility, muscle strength, motor coordination, and performance assessment utilizing functional movement screens. The physical examination is similar to a physical examination performed clinically in sports performance testing and also in the practice of Physical Therapy. The initial baseline measure will provide objective scores that can be utilized to assess for change over time. Additional information to be gathered includes demographic information on the subject including age, previous injury history, and level of exposure to physical performance training. These variables are associated with injury risk and also impact the potential for change with physical performance training. In addition, information on mental factors including stress, fear of failure, and burnout will be collected. It is hypothesized that these variables also factor into athletic performance. It is not known how these variables impact injury risk. Information on training load will be gathered weekly during the training period. Training load has a direct impact on muscle performance, and is hypothesized to impact injury risk. The subjects will be re-tested at the end of the training period to measure changes in physical performance and injury risk.
Project Procedures
Study population: High school athletes, ages 14 to 18, who are participating in an organized sports training program. The target subject enrollment is 250 high school athletes.
Inclusion criteria will be athletes who have completed a pre-participation sports physical, are enrolled in a sports elective or a member of a sports team, and have volunteered to participate in the study providing both verbal and written consent.
Exclusion criteria for participation include athletes who have not submitted a pre-participation sports physical to the high school training staff, student athletes who are currently suffering from an acute neuromusculoskeletal injury with restrictions on athletic participation, an athlete who has undergone surgery within a 3 month period of the program start date, an athlete who presents with a cardiovascular condition that would exclude exercise participation (systolic BP > 180, diastolic BP > 100), or athletes who are currently pregnant.
Study Methodology
Participants will complete a self-report questionnaire collecting demographic data including age, gender, primary and secondary sport activity, and previous injury history. Participants will also complete the Perceived Stress Scale to measure self-appraised stress, the Sports Mental Training Questionnaire to measure mental preparation skills, and the Athlete Burnout Questionnaire to assess emotional/physical exhaustion at the beginning and end of the 8 week program to assess psychological stressors associated with sport participation that may impact motivation to participate and perceived internal training load.
The structured physical performance assessment will include functional movement testing, motor coordination testing, joint mobility screen, muscle strength testing, and agility performance testing. Video analysis will be included with the functional movement testing utilizing software to assess reliability of the neuromuscular impairment screen.
Research project specific measures:
Functional movement testing includes:
- Forward flexion/hinge
- Standing trunk rotation
- Bilateral squat
- Forward lunge
- Lateral lunge
- Lower extremity functional reach test
- Upper extremity movement pattern (shoulder mobility test)
- Quadruped trunk rotary stability test
Mobility testing includes:
- Ankle mobility testing (DF, PF, IV, EV, first ray extension)
- Hip mobility testing (flexion, extension, abduction, IR, ER)
- Cervical mobility testing (flexion, extension, side bending, rotation, flexion rotation
- Thoracic mobility testing (seated trunk rotation)
- Shoulder mobility testing (flexion with scapular mobility assessment, abduction with scapular mobility assessment, IR, ER)
- Elbow mobility testing (flexion, extension, supination, pronation)
- Wrist mobility (flexion, extension)
Muscle strength testing:
- Hip strength (flexion, extension, abduction, ER, IR)
- Knee strength (flexion, extension)
- Ankle strength (PF, IV, EV)
- Shoulder strength (IR, ER, AB)
- Scapular strength (middle trap, lower trap)
- Elbow strength (flexion, extension)
Performance testing:
- Jump testing (bilateral long jump, unilateral jump, drop box jump)
- Upper extremity closed chain reach testing
- Shuttle run
Intrinsic and Extrinsic training load will be recorded weekly for subjects participating in the research study. Data will be utilized to calculate the training load associated with the school based strength and conditioning training program.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Janna M McGaugh, ScD
- Phone Number: 409-772-3068
- Email: jamcgaug@utmb.edu
Study Locations
-
-
Texas
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League City, Texas, United States, 77573
- Clear Falls High School
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Contact:
- Janna M McGaugh, ScD
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- athletes who have completed a pre-participation sports physical
- are enrolled in a sports elective or a member of a sports team
- have volunteered to participate in the study providing both verbal and written consent.
Exclusion Criteria:
- athletes who have not submitted a pre-participation sports physical to the high school training staff
- student athletes who are currently suffering from an acute neuromusculoskeletal injury with restrictions on athletic participation
- an athlete who has undergone surgery within a 3 month period of the program start date
- an athlete who presents with a cardiovascular condition that would exclude exercise participation (systolic BP > 180, diastolic BP > 100)
- an athletes who are currently pregnant.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
high school athletes
High school athletes, ages 14 to 18, who are participating in an organized sports training program.
|
The structured physical performance assessment will include functional movement testing, motor coordination testing, joint mobility screen, muscle strength testing, and agility performance testing.
These measures will assess the effectiveness of pre-season strength and conditioning program to reduce musculoskeletal impairments and increase resistance to injury.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in baseline movement quality as measured by the Selective Functional Movement Assessment (SFMA).
Time Frame: Pre (initial baseline), and after week 8 of preseason strength and condition training program
|
The Selective Functional Movement Assessment is an assessment to score movement quality on 7 functional movements.
The movement is categorically scored as: Functional and not painful (FN); Functional and painful (FP); Dysfunctional and not painful (DN); Dysfunctional and painful (DP)
|
Pre (initial baseline), and after week 8 of preseason strength and condition training program
|
Change in muscle strength testing as measured by hand held dynamometer.
Time Frame: Pre (initial baseline) and after week 8 of preseason strength and condition training program
|
Hand held dynamometer measures isometric force production in kilograms or pounds.
|
Pre (initial baseline) and after week 8 of preseason strength and condition training program
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Change in baseline movement quality as measured by the Anterior reach of the Y Balance Test.
Time Frame: Pre (initial baseline) and after week 8 of preseason strength and condition training program
|
The Anterior reach of the Y Balance Test measures distance of limb reach in centimeters.
Distance is compared from one side to the other to assess for symmetry.
A difference of > 4cm is a positive risk factor for lower extremity injury.
|
Pre (initial baseline) and after week 8 of preseason strength and condition training program
|
Change in baseline in motor performance as measured by the Single Leg Hop jump distance.
Time Frame: Pre (initial baseline) and after week 8 of preseason strength and condition training program
|
Single leg hop test measures hop distance in centimeters.
Distance hopped is compared between limbs, comparing strength and power symmetry between the two limbs.
|
Pre (initial baseline) and after week 8 of preseason strength and condition training program
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Change in baseline in motor performance as measured by the Modified T-Test drill completion time (seconds).
Time Frame: Pre (initial baseline) and after week 8 of preseason strength and condition training program
|
The Modified T-Test is an agility test that incorporates quick direction changes in a defined pattern.
The test is measured in seconds.
A reduction in the time to complete the drill represents improved motor performance and power.
|
Pre (initial baseline) and after week 8 of preseason strength and condition training program
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants who experience a musculoskeletal sports related injury.
Time Frame: End of study (1 year)
|
Measuring occurrence of musculoskeletal injury that is reported by the athlete and/or impacts participation practice or playing time during the training and competition season.
Number of missed days of practice and or sports competition will be recorded.
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End of study (1 year)
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Intrinsic training load as measured by perceived effort of the training session (Rate of Perceived Exertion Scale)
Time Frame: Weekly, for 8 weeks during the strength and conditioning training program
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Rate of Perceived Exertion Scale is a 0 to 10 scale that measures the perceived difficulty of a training sessions.
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Weekly, for 8 weeks during the strength and conditioning training program
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Collaborators and Investigators
Investigators
- Principal Investigator: Janna M McGaugh, ScD, UTMB
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-0135
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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