Local research. Human connections. WCR Miami Lakes (786) 483-7856
Back to study searchNCT07851298
By invitationNCT07851298ClinicalTrials.gov record

Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program

Anterior Cruciate Ligament Reconstruction · Anterior Cruciate Ligament Injuries · Anterior Cruciate Ligament Injury · Anterior Cruciate Ligament Tear

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
15 years - 25 years
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
30 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

The goal of this clinical trial is to learn whether an online mental and emotional support program called ACL Unbroken can help people recovering from ACL reconstruction surgery feel more confident and ready to return to sports when used alongside standard physical therapy.

The main questions this study aims to answer are:

  • Does the ACL Unbroken program help people feel more mentally prepared and confident to return to sports after ACL surgery?
  • Does the ACL Unbroken program improve recovery outcomes, such as physical performance, return to sports participation, satisfaction with recovery, and reducing the risk of another ACL injury?

Participants in the study will:

  • Continue to receive their usual physical therapy and medical care prescribed by their healthcare providers.
  • Complete surveys and assessments about their recovery, confidence, readiness to return to sports, and overall recovery experience.
  • Be assigned to one of two groups by chance.
  • If assigned to the intervention group, receive access to the ACL Unbroken online program, which includes educational lessons and activities focused on goal setting, confidence building, coping with fear of re-injury, stress management, motivation, mindfulness, meditation, visualization, and resilience during recovery.
  • If assigned to the comparison group, not receive access to the ACL Unbroken program during the study period.

If there is a comparison group, researchers will compare participants who receive the ACL Unbroken program with participants who receive standard care alone to see whether the program improves psychological readiness, recovery outcomes, and return-to-sport success after ACL reconstruction surgery.

Read the full description

This study evaluates the ACL Unbroken Program, an online psychological support program, in athletes aged 15 to 25 years who are recovering from primary anterior cruciate ligament (ACL) reconstruction with a bone-patellar tendon-bone autograft. The primary objective is to assess whether adding the ACL Unbroken Program to standard postoperative rehabilitation improves psychological readiness to return to sport and patient-reported outcomes following ACL reconstruction. Secondary objectives include evaluating physical performance outcomes, return-to-sport rates, reinjury incidence, participant satisfaction with recovery, and the feasibility and adherence associated with the program.

This is a single-site, prospective, randomized controlled pilot trial enrolling approximately 30 participants. Participants will be randomized in a 1:1 ratio to receive either standard rehabilitation alone or standard rehabilitation plus access to the ACL Unbroken Program. The study uses an open-label design due to the nature of the intervention, while outcome assessors will be blinded to group assignment when feasible. Participants will be followed for up to 24 months after enrollment.

The ACL Unbroken Program is a commercially available, web-based psychological readiness platform designed to support athletes throughout ACL rehabilitation. The program provides educational content and psychological skills training focused on confidence building, fear of reinjury, resilience, emotional regulation, recovery mindset, goal setting, and return-to-sport readiness. 15 participants, randomly assigned to the intervention group will have access to the ACL Unbroken Program in addition to receiving all standard clinical care and physical therapy prescribed by their healthcare providers.

Key assessments include validated patient-reported outcome measures evaluating psychological readiness, knee function, perceived social support, resilience, and recovery experience, as well as objective physical performance assessments such as quadriceps strength testing, hop testing, agility testing, change-of-direction testing, and movement biomechanics. Long-term follow-up assessments will also evaluate return-to-sport participation, reinjury occurrence, and participant satisfaction with recovery.

Psychological readiness has emerged as a critical factor influencing successful return to sport after ACL reconstruction, yet psychological support is not routinely incorporated into many rehabilitation programs. This study aims to provide preliminary evidence regarding the effectiveness and feasibility of integrating a structured psychological readiness program into standard ACL rehabilitation. Findings from this pilot trial will help inform the design of larger future studies and may contribute to improving recovery outcomes for athletes following ACL reconstruction.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria

  • Age 15 to 25 years
  • Athlete planning to return to sport after surgery
  • Undergoing primary ACL reconstruction with (BTB) Patellar tendon autograft

Exclusion Criteria

  • Undergoing primary ACL Reconstruction with a graft source other than (BTB) Patellar tendon autograft
  • Multi-ligamentous knee injury requiring repair or reconstruction
  • Previous ACL Reconstruction on affected or non-affected lower extremity
  • Concomitant articular cartilage procedures
  • Patients not planning to return to sport(s) after surgery
  • Unable to consistently access wifi or a device to complete the Unbroken Athlete online modular program
  • Undergoing 1-1 coaching with a behavioral psychotherapist
Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Random assignment
Masking
No masking
Standard of Care

Subjects in this arm will be randomized. They will not receive the Unbroken Athlete Program. Subjects will follow the standard of care treatment from their care team.

ACL Unbroken Athlete Program

Subjects in this arm will be randomized. They will receive the Unbroken Athlete Program. Subjects will follow the standard of care treatment from their care team and complete scheduled online modules as part of the intervention.

Other: Unbroken Comeback

Unbroken Comeback OTHER

The Unbroken Comeback is an online modular recovery program designed for athletes recovering from injury or surgery that focuses on the mental and emotional aspects of rehabilitation, not just the physical recovery. The program aims to help athletes rebuild confidence, resilience, and mindset so they can return to sport or activity stronger and more prepared.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Psychological Readiness to Return to Sport Following ACL Reconstruction at 12 Months

Time frame: 1 Year

Psychological readiness will be assessed using the Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) Scale. The ACL-RSI is a 12-item patient-reported outcome measure evaluating emotions, confidence, and risk appraisal related to returning to sport after ACL reconstruction. Scores range from 0 to 100, with higher scores indicating greater psychological readiness to return to sport. The mean ACL-RSI score at 12 months post-operatively will be reported.

Secondary measures

Patient-Reported Knee Function and Quality of Life Following ACL Reconstruction at 12 Months

Time frame: 1 year

Patient-reported knee function and quality of life will be assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS). The KOOS consists of five subscales: Pain, Symptoms, Activities of Daily Living, Sport and Recreation Function, and Knee-Related Quality of Life. Scores for each subscale range from 0 to 100, with higher scores indicating better knee health, function, and quality of life. Mean KOOS subscale scores at 12 months post-operatively will be reported.

Return to Pre-Injury Level of Sport Participation at 12 Months Following ACL Reconstruction

Time frame: 1 Year

Return to sport will be assessed as the proportion of participants who have returned to their pre-injury sport at the same or higher level of participation by 12 months following ACL reconstruction. Return-to-sport status will be determined through participant self-report and clinical follow-up assessments. Results will be reported as the percentage of participants meeting the return-to-sport criterion

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Inova Health System: Orthopedic, Sports MedicineFairfax, Virginia, United StatesStatus unknown

Study team and timeline

Lead sponsor
Inova Health Care Services
Study start
Nov 4, 2026 Actual
Primary completion
Nov 30, 2028 Estimated
Study completion
Dec 31, 2028 Estimated
First posted
Oct 1, 2026 Actual
Last updated
Nov 9, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

Evaluating A Comprehensive Psychological Readiness Program To Support Return To Sport After ACL Reconstruction: A Randomized Controlled Pilot Study

A HUMAN NEXT STEP

Ask Wellness Clinical Research

Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.

Please do not include medical records, diagnoses, medications, insurance numbers or other sensitive details. This form is for general questions, not urgent care.

Sending a question does not enroll you in a trial.

Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 9, 2026