Skip to content

Andrews Return to Sport ACL Score

The Andrews Return to Sport ACL Score: A Developmental Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05578248
Enrollment
100
Registered
2022-10-13
Start date
2022-02-03
Completion date
2023-06-30
Last updated
2022-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACL Injury

Keywords

Cohort, return to sport

Brief summary

This project will develop a data-driven decision making model to assess a competitive athlete's readiness to return to sport after ACL injury and surgery safely.

Detailed description

One hundred pre-collegiate or collegiate athlete participants will be recruited for this study. The duration of the treatment plan will be 24 months. Each of the participants will be qualified for the study due to falling within all inclusion criterion and no exclusion criterion. The screening of the inclusion criterion will occur at visit one of the study. At this time, the AREF Research Team will review and collect informed consent from each participant. Visit two will occur three (3) months after each participant's ACL reconstruction surgery. At this time, an evaluation by the treating physician will occur along with functional movement assessment and MRI. Visit three will occur six (6) months after each participant's ACL reconstruction surgery. At this time, an evaluation by the treating physician will occur along with functional movement assessment and MRI. Visit four will occur nine (9) months after each participant's ACL reconstruction surgery. At this time, an medical evaluation by the treating leading physician will occur along with functional movement assessment and MRI. Visit five will occur twelve (12) months after each participant's ACL reconstruction surgery. At this time, an evaluation by the treating physician will occur along with functional movement assessment and MRI. Visit six will occur eighteen (18) months after each participant's ACL reconstruction surgery. At this time, an evaluation by the treating physician will occur along with functional movement assessment and MRI. Visit seven will occur twenty-four (24) months after each participant's ACL reconstruction surgery. At this time, an evaluation by the treating physician will occur along with functional movement assessment and MRI. At each time point, the treating physician or the therapist performing the functional movement assessment can choose to limit the functional movement assessment if there are concerns that the patient may not be ready for the expected load of one or more elements of the functional movement assessment. At each monthly time point after ACL reconstruction, patient reported outcomes will be collected by the research team to assist in assessing the overall health and confidence in return to sport for each athlete. The following patient reported outcomes will be collected in written or electronic format after informed consent has been obtained from each participant: Sports Participation, Reinjury, Tampa Kinesiophobia Scale, IKDC, PROMIS, SANE.

Interventions

DIAGNOSTIC_TESTMagnetic Resonance Imaging (MRI)

Non-invasive imaging technology that produces three-dimensional detailed anatomical images

PROCEDUREACL reconstruction

Surgical procedure to repair damaged or severed anterior cruciate ligament in the knee

Sponsors

Florida
CollaboratorOTHER
Andrews Research & Education Foundation
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to 24 Years
Healthy volunteers
No

Inclusion criteria

* Age 14-24 years * Require ACL reconstruction surgery * No other ligament injury which would require repair or reconstruction to lower extremity is present as assessed by treating physician * Exhibits desire to return to pre-injury competitive level * Assessed to be in good physical health condition by the treating physician

Exclusion criteria

* Requires more than one ACL reconstruction surgery at time of screening * Has comorbid lower extremity diagnoses which would impede return to sport as assessed by the treating physician * Does not desire to return to pre-injury competitive sport level

Design outcomes

Primary

MeasureTime frameDescription
Tampa Scale for KinesiophobiaThrough study completion, an average of 1 yearMeasurement to determine the physical and pyschological effects on the rehabilitation of an injured athlete; 17-question survey with a total score calculated after inversion of the individual scores of items 4, 8, 12, and 16 (all questions are scored on a scale of 1-4 points).
Sports Participation AssessmentThrough study completion, an average of 1 yearQuantifies the participant's participation in sports activity during the rehabilitation period
Reinjury AssessmentThrough study completion, an average of 1 yearMonthly questionnaire to assess the rate of reinjury during rehabilitation process
International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)Every month, up to 1 year; assessing for change19-question form that will contribute to comprehensive data set by evaluating confidence in perfomance
Patient Reported Outcomes Measurement Information Systems (PROMIS)Every month, up to 1 year; assessing for changeAssesses overall health functioning and rehabilitation levels of each participant; required to ensure that a comprehensive assessment of overall functioning is reviewed. Scores range from 20 to 80, with 50 representing the average for the general population, and increases in this number over 50 represent standard deviation, and thus represent slow recovery progress in this study
Single Assessment Numeric Evaluation (SANE)Every month, up to 1 year; assessing for changeSingle question PRO with a rating of 0-100 for each participant to score their current functioning in comparison to their pre-injury level of function

Countries

United States

Contacts

Primary ContactJessi Truett, MA, BCBA
jessica.truett@andrewsref.org(850) 916-8570
Backup ContactChandler Bridges, MS
chandler.bridges@andrewsref.org(850) 916-8584

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026