Clinical trial NCT05343052: Hamstring Injury (HAMIR) Index
Official title: Hamstring Injury (HAMIR) Index: A Framework for Injury Mitigations Strategies Through Innovative Imaging, Biomechanics, and Data Analytics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hamstring Injury
Keywords: football
athlete
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Football League
First posted: 2022-04-25
Enrollment: 699
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Student-athlete rostered on the varsity football team of participating institutions between 5/1/2022-6/30/2025 (study period)

Brief summary: The investigators will combine state-of-the-art quantitative imaging, on-field biomechanics, and computational analytics into the largest-of-its-kind study to assess hamstring strain injury (HSI) risk and recovery in elite collegiate football players. The study will take place over 3 years and enroll up to 560 student athletes from Division I (D1) teams: University of Wisconsin-Madison, Brigham Young University and the University of North Carolina-Chapel Hill.

Detailed description: The current approach to assess hamstring strain injury (HSI) risk and recovery is suboptimal. Many player-games are lost in American Football due to the lack of a clear understanding of the risk factors for HSI and the absence of effective methods to minimize re-injury.

The investigators propose that the key issues are: 1) every athlete is unique; therefore, a "one-size-fits-all" approach to HSI risk assessment will not work; 2) clinicians have limited relevant information on the potential injury risk for a specific athlete; 3) current methods to assess the extent of injury in a specific athlete are largely qualitative, limiting the ability to determine re-injury risk; and 4) current use of biologic injections is common, yet studies to quantify their effects are lacking. In this study, the investigators will address these four critical barriers by combining state-of-the-art quantitative imaging, on-field biomechanics, and computational analytics into the largest-of-its-kind study of elite collegiate football players.

The study will be conducted in 4 Division I collegiate men's football teams over a 3-year period. All student-athletes enrolled in this study will complete preseason hamstring strength testing, inertial measurement units (IMU)-based sprinting biomechanics, and undergo baseline magnetic resonance imaging (MRI). Student-athletes will be monitored by athletic trainers throughout the school year, who will record injuries and participation (e.g., time in practice, game).

Student-athletes who sustain an HSI will undergo a clinical assessment at the time of injury along with an MRI examination. Following completion of a rehabilitation program, hamstring strength will be re-evaluated and imaging will be repeated, along with performance measurements.

This study will provide the most detailed understanding of the physiological causes and effects of HSI, advancing our understanding of the processes affecting muscle function and improving our ability to evaluate, treat, and prevent HSI. This study represents what will be the largest, most quantitative prospective cohort study ever into HSI. Data gathered as part of this study will be used to develop a quantitative Hamstring Injury (HAMIR) index such that the medical and scientific communities can identify an individual athlete's propensity for HSI, and, more importantly, identify targets for injury mitigation, thereby reducing the global burden of HSI.

Aim 1. Develop a risk prediction model for HSI based on morphological, architectural, biomechanical and clinical factors in National Collegiate Athletic Association (NCAA) D1 college football players. The goal is to test the predictive capacity of innovative measures of risk for initial HSI in the largest prospective cohort study ever conducted in HSI. The outcome will be the establishment of a quantitative HAMIR index that is based on multiple athlete-specific measures. This aim will also identify potential future targets for injury risk mitigation and prophylactic strategies.

Aim 2. Develop a risk prediction model for recurrent HSI based on morphological, architectural, biomechanical and clinical factors (identified in Aim 1) in NCAA D1 college football players by completing the largest ever analysis of re-injury data. The investigators will track players who sustain an HSI, both immediately after injury and longitudinally. Quantification of injury metrics (e.g., volume of initial edema and volume, shape and location of long-term scar) will be incorporated into the analytics framework to develop a new "re-injury" HAMIR index. Similar to Aim 1, this aim will identify potential future targets for re-injury risk mitigation and prophylactic approaches.

Eligibility criteria: Inclusion Criteria:

* Student-athlete rostered on the varsity football team of participating institutions between 5/1/2022-6/30/2025 (study period)

Exclusion Criteria:

* History of malignant disease
* Contraindication to MRI

Primary outcomes:
measure: Aim 1: Initial Hamstring Strain Injury (HSI)
timeFrame: up to 3 years
measure: Aim 2: Recurrent Hamstring Strain Injury (HSI)
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
measure: Change in inertial measurement units (IMU)-based sprinting biomechanics
timeFrame: baseline and within 7 days of RTS (variable time points during training and within season)
measure: Change in eccentric strength
timeFrame: baseline and within 7 days of RTS (variable time points during training and within season)
measure: Change in Hamstring Outcome Score (HaOS)
timeFrame: baseline
measure: Change in Conventional MRI
timeFrame: baseline, within 7 days of injury, within 7 days of RTS (variable time points during training and within season)
measure: Change in Functional Assessment Scale for Acute Hamstring Injuries (FASH) Score
timeFrame: within 7 days of injury, within 7 days of RTS (variable time points during training and within season)
measure: Number of practice and competition exposures for each athlete
timeFrame: up to 3 years
measure: Clinical Assessment of Pain
timeFrame: time of injury, within 7 days of RTS
measure: Functional Assessment: Range of Motion
timeFrame: time of injury, within 7 days of RTS
Locations:
city: Bloomington
country: United States
facility: Indiana University
state: Indiana
city: Notre Dame
country: United States
facility: Notre Dame University
state: Indiana
city: Chapel Hill
country: United States
facility: University of North Carolina - Chapel Hill
state: North Carolina
city: Provo
country: United States
facility: Brigham Young University
state: Utah
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: UW School of Medicine and Public Health
name: Bryan Heiderscheit, PT, PhD, FAPTA
role: PRINCIPAL_INVESTIGATOR
affiliation: Australian Catholic University
name: David Opar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Springbok Analytics
name: Silvia Blemker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heiderscheit BC, Blemker SS, Opar D, Stiffler-Joachim MR, Bedi A, Hart J, Mortensen B, Kliethermes SA; HAMIR Study Group. The development of a HAMstring InjuRy (HAMIR) index to mitigate injury risk through innovative imaging, biomechanics, and data analytics: protocol for an observational cohort study. BMC Sports Sci Med Rehabil. 2022 Jul 15;14(1):128. doi: 10.1186/s13102-022-00520-3.