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

NCT ID: NCT04593264

Last Updated: 2023-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-23
• Study Completion Date: 2022-06-30

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.

Conditions

Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Tear; Anterior Cruciate Ligament Injuries

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Traditional Supervised Prehabilitation with a Physical Therapist

Group Type: ACTIVE_COMPARATOR

Traditional pre-habilitation

Intervention Type: OTHER

Pre-habilitation exercise sessions under the direct supervision of a physical therapist.

Self-guided Home-based Prehabilitation

Group Type: EXPERIMENTAL

Self-guided pre-habilitation exercise program

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Traditional pre-habilitation

Pre-habilitation exercise sessions under the direct supervision of a physical therapist.

Intervention Type: OTHER

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

WellSpan Health

OTHER

Sponsor Role: lead

Responsible Party

John Deitch

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

WellSpan Health

York, Pennsylvania, United States

Countries

United States

Other Identifiers

1168599

Identifier Type: -

Identifier Source: org_study_id