NCT04593264

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

February 23, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

1.3 years

First QC Date

October 13, 2020

Last Update Submit

March 23, 2023

Conditions

Anterior Cruciate Ligament RuptureAnterior Cruciate Ligament TearAnterior Cruciate Ligament Injuries

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

Traditional Supervised Prehabilitation with a Physical Therapist

ACTIVE COMPARATOR
Other: Traditional pre-habilitation

Self-guided Home-based Prehabilitation

EXPERIMENTAL
Other: Self-guided pre-habilitation exercise program

Interventions

Self-guided pre-habilitation exercise programOTHER

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

Self-guided Home-based Prehabilitation
Traditional pre-habilitationOTHER

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

Traditional Supervised Prehabilitation with a Physical Therapist

Eligibility Criteria

Age13 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WellSpan Health

York, Pennsylvania, 17403, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 13, 2020

First Posted

October 19, 2020

Study Start

February 23, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

March 27, 2023

Record last verified: 2023-03

Locations

US(1)