Skip to main content
Clinical Trials/NCT04593264
NCT04593264
Completed
Not Applicable

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

WellSpan Health1 site in 1 country128 target enrollmentFebruary 23, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anterior Cruciate Ligament Rupture
Sponsor
WellSpan Health
Enrollment
128
Locations
1
Primary Endpoint
Number of Participants Ready for ACL repair surgery
Status
Completed
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
February 23, 2021
End Date
June 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

John Deitch

Principal Investigator

WellSpan Health

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

Outcomes

Primary Outcomes

Number of Participants Ready for ACL repair surgery

Time Frame: 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 Outcomes

  • Thigh circumference(Approximately 4 weeks following initiation of a pre-habilitation program)
  • Knee Range of Motion(Approximately 4 weeks following initiation of a pre-habilitation program)

Study Sites (1)

Loading locations...

Similar Trials