Psychological Readiness Program for ACL Reconstruction

(UnbrokenACL Trial)

PS
EC
Overseen ByEdward Chang, MD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Inova Health Care Services
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether an online support program called ACL Unbroken can boost athletes' confidence and readiness to return to sports after ACL surgery. The study compares recovery outcomes, such as physical performance and satisfaction, between participants who use the program and those who do not. All participants will continue their usual physical therapy, with some also using the ACL Unbroken program, which includes lessons on goal setting, confidence, and stress management. Athletes aged 15 to 25 planning to return to sports after ACL surgery with a BTB Patellar tendon autograft may be well-suited for this trial.

As an unphased trial, this study provides athletes with a unique opportunity to enhance their recovery journey with additional support and resources.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. You will continue to receive your usual physical therapy and medical care as prescribed by your healthcare providers.

What prior data suggests that the ACL Unbroken program is safe for use in ACL recovery?

Research has shown that the ACL Unbroken program is safe for participants. This online tool provides psychological support for individuals recovering from ACL (anterior cruciate ligament) surgery. Studies have found that it boosts mental readiness and confidence for returning to sports.

The program includes lessons and activities focused on setting goals, building confidence, managing stress, and practicing mindfulness. Its online and non-invasive nature means there are no reported physical side effects. Participants continue their regular physical therapy and medical care, enhancing the program's safety.

Overall, the ACL Unbroken program receives positive feedback. No reports of negative effects have emerged from using this online support, and participants generally find it a helpful part of their recovery.12345

Why are researchers excited about this trial?

Researchers are excited about the ACL Unbroken Athlete Program because it offers a new approach to preparing for ACL reconstruction surgery by focusing on psychological readiness. Unlike standard care, which typically involves physical therapy and surgical preparation, this program integrates online modules designed to boost mental resilience and readiness, potentially enhancing recovery outcomes. By addressing both the mental and physical aspects of recovery, the program aims to improve overall patient outcomes, which could revolutionize how we approach ACL injuries.

What evidence suggests that the ACL Unbroken program is effective for improving recovery after ACL surgery?

Research has shown that mental and emotional support can significantly enhance recovery after surgery. For those recovering from ACL reconstruction, mental readiness is crucial for a successful return to sports. In this trial, participants will be randomized into two groups: one receiving the ACL Unbroken Athlete Program and the other following standard care without the program. Early findings suggest that programs like ACL Unbroken, which emphasize mental preparation, can boost confidence and reduce the fear of reinjury. These programs employ techniques such as goal setting and stress management to improve overall satisfaction with recovery and physical performance. Although direct data on ACL Unbroken is limited, similar programs have improved recovery experiences.678910

Who Is on the Research Team?

ES

Edward S Chang, MD

Principal Investigator

Inova Health Care Services

Are You a Good Fit for This Trial?

This trial is for people who have had ACL reconstruction surgery and are recovering, aiming to return to sports. Participants should be receiving standard physical therapy and medical care as part of their recovery.

Inclusion Criteria

I plan to return to my sport after surgery.
I am between 15 and 25 years old.
I am having my ACL repaired using my own patellar tendon.

Exclusion Criteria

I am having my ACL reconstructed using a graft that is not from my patellar tendon.
I do not plan to return to sports after my surgery.
I have had ACL reconstruction surgery on one or both legs.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard rehabilitation with or without the ACL Unbroken Program

12 months
Regular physical therapy sessions and online module completion

Follow-up

Participants are monitored for psychological readiness, knee function, and return-to-sport outcomes

12 months
Long-term follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

  • ACL Unbroken program

Trial Overview

The study tests whether an online mental support program called ACL Unbroken, used alongside regular physical therapy, helps boost confidence and readiness to return to sports after ACL surgery. Participants are randomly assigned to either use the program or continue with usual care only.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: ACL Unbroken Athlete ProgramExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Inova Health Care Services

Lead Sponsor

Trials
80
Recruited
22,700+

Citations

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