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

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04593264
• Other study ID #: 1168599
• Status: Completed
• Phase: N/A
• Start date: February 23, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: March 2023
• Source: WellSpan Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Rupture
• Anterior Cruciate Ligament Tear
• Rupture

Intervention

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

Locations

Country	Name	City	State
United States	WellSpan Health	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
WellSpan Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Thigh circumference	Difference in thigh circumference from baseline to final pre-operative check-in	Approximately 4 weeks following initiation of a pre-habilitation program