Back to resultsQuantifying the Benefits of Supervised vs. Unsupervised Pre-habilitation for Patients With Acute ACL Tears
Primary Purpose
Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear, Anterior Cruciate Ligament Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-guided pre-habilitation exercise program
Traditional pre-habilitation
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Rupture
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
Sites / Locations
- WellSpan Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Traditional Supervised Prehabilitation with a Physical Therapist
Self-guided Home-based Prehabilitation
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Knee Range of Motion
Difference in knee range of motion from baseline to final pre-operative check-in
Thigh circumference
Difference in thigh circumference from baseline to final pre-operative check-in
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04593264
Brief Title
Quantifying the Benefits of Supervised vs. Unsupervised Pre-habilitation for Patients With Acute ACL Tears
Official Title
Quantifying the Benefits of Supervised vs. Unsupervised Pre-habilitation for Patients With Acute ACL Tears
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 23, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
WellSpan Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear, Anterior Cruciate Ligament Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional Supervised Prehabilitation with a Physical Therapist
Arm Type
Active Comparator
Arm Title
Self-guided Home-based Prehabilitation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Self-guided pre-habilitation exercise program
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Traditional pre-habilitation
Intervention Description
Pre-habilitation exercise sessions under the direct supervision of a physical therapist.
Primary Outcome Measure Information:
Title
Number of Participants Ready for ACL repair surgery
Description
The surgeon will decide if the patient's knee is optimized and ready for surgery based on quadricep circumference and range of motion.
Time Frame
Approximately 4 weeks following initiation of a pre-habilitation program
Secondary Outcome Measure Information:
Title
Knee Range of Motion
Description
Difference in knee range of motion from baseline to final pre-operative check-in
Time Frame
Approximately 4 weeks following initiation of a pre-habilitation program
Title
Thigh circumference
Description
Difference in thigh circumference from baseline to final pre-operative check-in
Time Frame
Approximately 4 weeks following initiation of a pre-habilitation program
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
WellSpan Health
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Quantifying the Benefits of Supervised vs. Unsupervised Pre-habilitation for Patients With Acute ACL Tears
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