Predictive Factors for a Successful Return to Run After ACL-R

October 15, 2019 updated by: Jean-Sébastien Roy, Laval University

Predictive Factors for a Successful Return to Run After Anterior Cruciate Ligament Reconstruction and Underlying Bio-mechanical Factors

After anterior cruciate ligament (LCA) rupture, the recommended treatment for athletes is the surgical reconstruction of the ligament (ACL-R), followed by a long rehabilitation period. The results of this treatment are sub-optimal with a low rate of return to pre-injury level of sport, a high risk of reinjury and early knee osteoarthritis. To improve treatment outcomes, researchers and clinicians recommend optimizing rehabilitation protocols. They recommend individualizing rehabilitation progression based on objective criteria. However, current defined criteria relied on experts' opinions and not scientific validation.

Return to run after ACL reconstruction is an important rehabilitation milestone. It often means the beginning of the return to sport continuum. A successful return to run is therefore crucial for both the patient and clinician. In this study, the investigators aim to determine the predictive outcomes for a successful return to run after ACL-R.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Quebec City, Quebec, Canada
        • Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Experimental group

Inclusion Criteria:

  • ACL-R 3 to 4 months ago

Exclusion Criteria:

  • already returned to run
  • multiple ligament lesions

Control group

Inclusion Criteria:

- healthy person

Exclusion Criteria:

  • history of ACL lesion or reconstruction
  • history of knee injury
  • injured in the last year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: ACL-R
Other: Retrun to run protocol
Progressive return to run protocol for patients after ACL-R

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscular strength assessment
Time Frame: Day 0
Quadriceps, hamstring and gluteus strength assessment with handheld dynamometer (N)
Day 0
Modified Y-balance test
Time Frame: Day 0
Modified Y-balance test (m)
Day 0
step-down test
Time Frame: Day 0
endurance test, number of repetition
Day 0
Self-reported outcomes: ACL-RSI
Time Frame: Day 0
ACL-RSI: 0-100
Day 0
Self-reported outcomes: IKDC
Time Frame: Day 0
IKDC: 0-100
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Running kinematic
Time Frame: Day 0 and Day 14
knee kinematic (degree)
Day 0 and Day 14
Running kinetic
Time Frame: Day 0 and Day 14
kinetic (N)
Day 0 and Day 14
Knee joint contact force
Time Frame: Day 0 and Day 14
knee joint contact force (N)
Day 0 and Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

Ordre Professionnel de la Physiothérapie du Québec (OPPQ)

Investigators

  • Principal Investigator: Jean-Sébastien Roy, PhD, Laval University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2018

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

April 30, 2019

Study Registration Dates

First Submitted

October 11, 2019

First Submitted That Met QC Criteria

October 15, 2019

First Posted (Actual)

October 17, 2019

Study Record Updates

Last Update Posted (Actual)

October 17, 2019

Last Update Submitted That Met QC Criteria

October 15, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • ACLR/Running 2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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