Athletic InjuriesNCT04095260
Identification of Neuromusculoskeletal Variables Associated With Injury Risk and Performance in High School Athletes.
An observational study of Athletic Injuries, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The purpose of this study is to complete a neuromuscular performance assessment of high school athletes who are participating in school based pre-season strength and performance training program. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletic Injuries
- What is being tested?
- Pre-season strength and conditioning program
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2028to 30 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Clear Falls High School
League City, Texas, 77573
Janna M McGaugh, ScD
About this study
The purpose of this study is to complete a neuromuscular performance assessment of high school athletes who are participating in school based pre-season strength and performance training program. The performance assessment will screen for existing muscle imbalances and strength deficits known to increase risk for sports injury, and provide a baseline performance measurement. Athletes will be measured before the start of the program and then again at the end of the pre-season training period to measure changes in motor coordination, muscle strength, and performance and injury risk category. Internal and external training load will be measured weekly during the training program to track intensity of the training program. In addition to the pre and post measurements, sports injury occurrence and time away from sports participation will be tracked throughout the sport season/school year to evaluate training program outcomes and accuracy of risk assessment.
Read the 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.
- Conditions
- Athletic Injuries
- Being tested
- Pre-season strength and conditioning program
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-season strength and conditioning programOther
Also called pre and post physical performance testing following a high school based strength and conditioning 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.
| Study group | Role | What they receive |
|---|---|---|
| high school athletes | High school athletes, ages 14 to 18, who are participating in an organized sports training program. Receives: Other: Pre-season strength and conditioning program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline movement quality as measured by the Selective Functional Movement Assessment (SFMA).
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)
Measured: 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.
Hand held dynamometer measures isometric force production in kilograms or pounds.
Measured: Pre (initial baseline) and after week 8 of preseason strength and condition training program
Change in baseline movement quality as measured by the Anterior reach of the Y Balance Test.
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.
Measured: 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.
Single leg hop test measures hop distance in centimeters. Distance hopped is compared between limbs, comparing strength and power symmetry between the two limbs.
Measured: Pre (initial baseline) and after week 8 of preseason strength and condition training program
Change in baseline in motor performance as measured by the Modified T-Test drill completion time (seconds).
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.
Measured: Pre (initial baseline) and after week 8 of preseason strength and condition training program
Secondary outcomes (2)
Number of participants who experience a musculoskeletal sports related injury.
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.
Measured: End of study (1 year)
Intrinsic training load as measured by perceived effort of the training session (Rate of Perceived Exertion Scale)
Rate of Perceived Exertion Scale is a 0 to 10 scale that measures the perceived difficulty of a training sessions.
Measured: Weekly, for 8 weeks during the strength and conditioning training program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Aug 2028 (estimated)
- Primary completion30 Aug 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletic InjuriesStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janna M McGaugh, ScD, Principal investigator, UTMB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095260
- Sponsor's protocol ID
- 19-0135
- Status last verified
- Feb 2026
- First submitted
- 16 Sep 2019
- Last updated
- 10 Feb 2026
- 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 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Neuromusculoskeletal Variables Associated With Injury Risk and Performance in High School Athletes.
- ClinicalTrials.gov ID
- NCT04095260
- Acronym / sponsor ID
- 19-0135
- Conditions
- Athletic Injuries
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 1 Aug 2028 (estimated)
- Primary completion
- 30 Aug 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 19 Sep 2019 (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.
The purpose of this study is to complete a neuromuscular performance assessment of high school athletes who are participating in school based pre-season strength and performance training program. The performance assessment will screen for existing muscle imbalances and strength deficits known to increase risk for sports injury, and provide a baseline performance measurement. Athletes will be measured before the start of the program and then again at the end of the pre-season training period to measure changes in motor coordination, muscle strength, and performance and injury risk category. Internal and external training load will be measured weekly during the training program to track intensity of the training program. In addition to the pre and post measurements, sports injury occurrence and time away from sports participation will be tracked throughout the sport season/school year to evaluate training program outcomes and accuracy of risk assessment.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| high school athletes | – | Other: Pre-season strength and conditioning programHigh school athletes, ages 14 to 18, who are participating in an organized sports training program. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Pre-season strength and conditioning programAlso: pre and post physical performance testing following a high school based strength and conditioning training programThe 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 | high school athletes |
Primary outcome
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)
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.
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.
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.
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.
2 secondary outcomes
Number of participants who experience a musculoskeletal sports related injury.
Time frame: End of study (1 year)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- 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.
Janna M McGaugh, ScD principal investigator
UTMB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Athletic Injuries, run by The University of Texas Medical Branch, Galveston 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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 10 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janna M McGaugh, ScD (409-772-3068, jamcgaug@utmb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 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 10 Feb 2026.