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

Not Applicable

Completed

• Conditions: Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Tear
• Interventions: Other: Self-guided pre-habilitation exercise program; Other: Traditional pre-habilitation

• Registration Number: NCT04593264
• Lead Sponsor: WellSpan Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-13
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-19
• Study Start: 2021-02-23
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-guided Home-based Prehabilitation	Self-guided pre-habilitation exercise program	-
Traditional Supervised Prehabilitation with a Physical Therapist	Traditional pre-habilitation	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

WellSpan Health; 🇺🇸 York, Pennsylvania, United States