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Clinical Trials/NCT04593264
NCT04593264CompletedNot Applicable

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

WellSpan Health1 site in 1 country128 target enrollmentStarted: February 23, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
128
Locations
1
Primary Endpoint
Number of Participants Ready for ACL repair surgery

Study 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
13 Years to 50 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Traditional Supervised Prehabilitation with a Physical Therapist

Active Comparator

Intervention: Traditional pre-habilitation (Other)

Self-guided Home-based Prehabilitation

Experimental

Intervention: Self-guided pre-habilitation exercise program (Other)

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

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

John Deitch

Principal Investigator

WellSpan Health

Study Sites (1)

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