NCT04050319

Brief Summary

To use existing standard-of-care documentation in a sports medicine electronic medical record (EMR) to evaluate patient characteristics, interventions delivered, utilization management, and clinical outcomes in routine sports medicine care, in order to generate evidence to improve clinical effectiveness and quality of care.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
550,000

participants targeted

Target at P75+ for all trials

Timeline
36mo left

Started Apr 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress1%
Apr 2026Apr 2029

First Submitted

Initial submission to the registry

August 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2019

Completed
6.7 years until next milestone

Study Start

First participant enrolled

April 23, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2029

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

August 5, 2019

Last Update Submit

April 28, 2026

Conditions

Keywords

concussionsFracturesInstabilitySprainsStrains

Outcome Measures

Primary Outcomes (2)

  • Numerical Rating Scale (NRS)

    Subjective; Patients rate pain on a scale from 0 (no pain) to 10 (worst pain imaginable).

    Baseline (Day 1 at Evaluation), throughout patient's episode of care asked each visit, on average up to 12 weeks

  • Single Assessment Numeric Evaluation (SANE)

    Subjective, Patient-perceived overall function or pain related to a specific condition compared to pre-injury. 0% (least possible) to 100% (most possible/normal)

    Administered at initial evaluation, and every 4th visit for the patient's episode of care (on average 12 weeks).

Interventions

Athletic Training and Physical Therapy

Also known as: athletic training

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals receiving medical and/or preventative services when part of an organized sports team.

You may qualify if:

  • Care setting and timeframe: Received sports medicine services at ATI Physical Therapy, with documentation available in the ATI Sports Medicine EMR, on or after January 1, 2018, through the date of data extraction.
  • Age range: Sports participants including middle school, high school and collegiate aged including adolescents through young adults that have been documented in the EMR.
  • Record availability: Have an EMR record that includes the minimum data elements necessary to address the study objectives (e.g., episode identifiers/dates sufficient to define an episode of care, diagnosis/body region, utilization variables, and at least one routinely collected outcome measure when applicable to the specific analysis).
  • Standard-of-care data: Data were collected as part of routine clinical care/documentation prior to and independent of this research study.

You may not qualify if:

  • The record is outside the eligible timeframe or does not reflect sports medicine care at ATI.
  • The record is a duplicate or cannot be reliably linked within the data source to a single episode/patient for analysis.
  • The record lacks the minimum necessary variables required for the specific analysis (e.g., missing episode dates needed to define utilization metrics; missing baseline/discharge outcome for analyses requiring change scores).
  • The data are corrupted, internally inconsistent (e.g., impossible dates), or otherwise unsuitable for analysis after standard data cleaning.
  • The record cannot be adequately coded/de-identified for analysis and reporting under the study's privacy/confidentiality procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ATI

Downers Grove, Illinois, 60515, United States

Location

Related Publications (6)

  • Herring SA. The team physician and return-to-play issues: a consensus statement. Medicine & Science in Sports & Exercise. 2002;34(7):1212-1214.

    BACKGROUND
  • Martin CL, Greene J, David RB, Kliethermes S, Naylor J, Kucera K. Athletic Trainers as Outpatient Rehabilitation Providers: An Analysis of Role, Value, and Insurance Reimbursement in a Large Academic Healthcare System. Journal of Athletic Training. 2025;1(aop)

    BACKGROUND
  • Patel DR, Yamasaki A, Brown K. Epidemiology of sports-related musculoskeletal injuries in young athletes in United States. Translational pediatrics. 2017;6(3):160.

    BACKGROUND
  • Brenner JS, Watson A. Overuse injuries, overtraining, and burnout in young athletes. Pediatrics. 2024;153(2):e2023065129.

    BACKGROUND
  • Coronado VG, Haileyesus T, Cheng TA, et al. Trends in sports-and recreation-related traumatic brain injuries treated in US emergency departments: the National Electronic Injury Surveillance System-All Injury Program (NEISS-AIP) 2001-2012. The Journal of head trauma rehabilitation. 2015;30(3):185-197.

    BACKGROUND
  • Rui P, Ashman JJ, Akinseye A. Emergency department visits for injuries sustained during sports and recreational activities by patients aged 5-24 years, 2010-2016. 2019

    BACKGROUND

MeSH Terms

Conditions

Fractures, BoneSprains and Strains

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Chris Stout, PsyD

    ATI

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
3 Years
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research

Study Record Dates

First Submitted

August 5, 2019

First Posted

August 8, 2019

Study Start

April 23, 2026

Primary Completion (Estimated)

April 23, 2029

Study Completion (Estimated)

April 23, 2029

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations