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

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.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Tear
• Intervention / Treatment: Other: Traditional pre-habilitation; Other: Self-guided pre-habilitation exercise program

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • York, Pennsylvania, United States, 17403
      • WellSpan Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional Supervised Prehabilitation with a Physical Therapist	Other: Traditional pre-habilitation; Pre-habilitation exercise sessions under the direct supervision of a physical therapist.
Experimental: Self-guided Home-based Prehabilitation	Other: Self-guided pre-habilitation exercise program; 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

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

Collaborators and Investigators

• Sponsor: WellSpan Health

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: October 13, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Rupture; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: 1168599

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No