Quantifying the Benefits of Supervised vs. Unsupervised Pre-habilitation for Patients With Acute ACL Tears

Study Overview
=================
Brief 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.

Official Title
-----------------
Quantifying the Benefits of Supervised vs. Unsupervised Pre-habilitation for Patients With Acute ACL Tears

Conditions
-----------------
Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear, Anterior Cruciate Ligament Injuries

Intervention / Treatment
-----------------
* Other: Self-guided pre-habilitation exercise program
* Other: Traditional pre-habilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional Supervised Prehabilitation with a Physical Therapist<br> | Other: Traditional pre-habilitation<br>* Pre-habilitation exercise sessions under the direct supervision of a physical therapist.<br>|
| Experimental: Self-guided Home-based Prehabilitation<br> | Other: Self-guided pre-habilitation exercise program<br>* A set of self-guided exercises developed by an athletic trainer to perform at home in order to optimize the knee for ACL repair surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Ready for ACL repair surgery | The surgeon will decide if the patient's knee is optimized and ready for surgery based on quadricep circumference and range of motion. | Approximately 4 weeks following initiation of a pre-habilitation program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Range of Motion | Difference in knee range of motion from baseline to final pre-operative check-in | Approximately 4 weeks following initiation of a pre-habilitation program | 
| Thigh circumference | Difference in thigh circumference from baseline to final pre-operative check-in | Approximately 4 weeks following initiation of a pre-habilitation program |