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OpenTrials
Completed

NCT Number: NCT04593264

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

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.

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Key information

Conditions

Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament Tear Knee Injuries Leg Injuries Wounds and Injuries

Age range

13 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

WellSpan Health

York, Pennsylvania, 17403, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-guided pre-habilitation exercise program

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

Traditional pre-habilitation

Other

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

Primary outcomes

  1. 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

  1. Knee Range of Motion

    Time frame: Approximately 4 weeks following initiation of a pre-habilitation program

    Difference in knee range of motion from baseline to final pre-operative check-in

  2. Thigh circumference

    Time frame: Approximately 4 weeks following initiation of a pre-habilitation program

    Difference in thigh circumference from baseline to final pre-operative check-in

Sponsors and collaborators

Lead sponsor

WellSpan Health

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 19, 2020
Registry last updated
Mar 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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