About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 15 to 25 years
Athlete planning to return to sport after surgery
Undergoing primary ACL reconstruction with (BTB) Patellar tendon autograft
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Unbroken Comeback
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Psychological Readiness to Return to Sport Following ACL Reconstruction at 12 Months
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 outcomes
Patient-Reported Knee Function and Quality of Life Following ACL Reconstruction at 12 Months
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
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
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: