NCT05343052

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
699

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

April 25, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2025

Completed
Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

3.1 years

First QC Date

April 15, 2022

Last Update Submit

June 5, 2025

Conditions

Keywords

footballathlete

Outcome Measures

Primary Outcomes (2)

  • Aim 1: Initial Hamstring Strain Injury (HSI)

    The outcome will be occurrence of an index HSI, measured at the athlete level. Athlete characteristics will be used to develop the quantitative HAMIR index to predict those at greatest risk of HSI. This aim will also identify potential future targets for injury risk mitigation and prophylactic strategies. HSI defined as an acute injury to the posterior thigh that limits full, unrestricted sports participation and includes two or more of the following symptoms: palpable pain along the hamstring muscles, posterior thigh pain without radicular symptoms, weakness and/or pain with resisted knee flexion, and pain with running.

    up to 3 years

  • Aim 2: Recurrent Hamstring Strain Injury (HSI)

    The outcome will be the occurrence of a recurrent, or secondary, HSI measured at the athlete level. The investigators will use quantification of injury metrics (e.g., volume of initial edema and volume, shape and location of long-term scar) and incorporate these 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. Re-injury will be defined as an acute HSI that occurs to either limb within 6 months of an index HSI.

    up to 3 years

Other Outcomes (8)

  • Change in inertial measurement units (IMU)-based sprinting biomechanics

    baseline and within 7 days of RTS (variable time points during training and within season)

  • Change in eccentric strength

    baseline and within 7 days of RTS (variable time points during training and within season)

  • Change in Hamstring Outcome Score (HaOS)

    baseline

  • +5 more other outcomes

Study Arms (1)

Student Athlete

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

Other: Patient Reported Outcomes SurveysOther: Clinical AssessmentsOther: Biomechanical and Neuromuscular AssessmentsDevice: Conventional MRI

Interventions

* Oslo Sports Trauma Research Center Hamstring Injury Screening Questionnaire (HaOS) at baseline * Functional Assessment Scale for Acute Hamstring Injuries (FASH) within 7 days of injury and within 7 days of return to sport (RTS)

Also known as: HaOS, FASH
Student Athlete

* Injury History at baseline, within 7 days of injury, within 7 days of RTS * Pain and Function Assessments within 7 days of injury, within 7 days of RTS

Student Athlete

* Eccentric Strength measure at baseline and within 7 days of RTS * Sprinting Biomechanics at baseline and within 7 days of RTS

Student Athlete

at baseline, within 7 days of injury, and within 7 days of RTS

Also known as: Magnetic Resonance Imaging (MRI)
Student Athlete

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • History of malignant disease
  • Contraindication to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Indiana University

Bloomington, Indiana, 47405, United States

Location

Notre Dame University

Notre Dame, Indiana, 46556, United States

Location

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Brigham Young University

Provo, Utah, 84602, United States

Location

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Bryan Heiderscheit, PT, PhD, FAPTA

    UW School of Medicine and Public Health

    PRINCIPAL INVESTIGATOR
  • David Opar, PhD

    Australian Catholic University

    PRINCIPAL INVESTIGATOR
  • Silvia Blemker, PhD

    Springbok Analytics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2022

First Posted

April 25, 2022

Study Start

April 25, 2022

Primary Completion

June 5, 2025

Study Completion

June 5, 2025

Last Updated

June 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations