Quantifying the Benefits of Supervised vs. Unsupervised Pre-habilitation for Patients With Acute … (NCT04593264) | Clinical Trial Compass
CompletedNot Applicable
Quantifying the Benefits of Supervised vs. Unsupervised Pre-habilitation for Patients With Acute ACL Tears
United States128 participantsStarted 2021-02-23
Plain-language summary
Although the success of physical therapy following surgery has been well-documented and validated in patients undergoing Anterior Cruciate Ligament Reconstruction (ACLR) procedures, more recent studies have demonstrated that patient outcomes are the most favorable when surgery is delayed approximately 4 weeks until after the patient has completed a preoperative physical therapy program, or "pre-habilitation." The ultimate goal of pre-habilitation is to regain full range of motion in the knee and reach approximately 80% of pre-injury quadricep strength. However, extra physical therapy can stress both time and resources. Thus, we propose a home-based, self-guided pre-habilitation program. We hypothesize that patients participating in self-guided pre-habilitation will experience the same benefits as patients in a traditional office-based physical therapy program.
Who can participate
Age range
13 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Skeletal maturity
* Acute ACL rupture occurring no longer than 4 weeks prior to presentation
* Ability to participate in a pre-habilitation program
* Nature of the injury allows adequate time for pre-habilitation
* Ability to speak, read, and understand English
* Willing and able to provide informed consent
Exclusion Criteria:
* Any injuries requiring immediate surgical intervention
* Ipsilateral meniscus tear that preventing participation in a pre-habilitation program
* Ipsilateral MCL tears grade III
* Ipsilateral PCL tears (any grade)
* Concomitant LCL injuries
* Concomitant posterolateral corner injuries
* Inflammatory arthritis
* Prior ACL rupture/reconstruction
* Anyone unable to participate in a stretching/strengthening program
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Ready for ACL repair surgery
Timeframe: Approximately 4 weeks following initiation of a pre-habilitation program