Laval University Rouge et or Post ACL Surgery Program Effectiveness

October 25, 2019 updated by: Laval University

Laval University Rouge et Or Post Anterior Cruciate Ligament Surgery Readaptation Program Effectiveness With Amateur Athletes: A Randomised Clinical Trial

The main objective is to compare the effectiveness of two readaptation programs post anterior cruciate ligament surgery. Laval University Rouge et or program is to be compared with the intervention guide from the CHU. Amateur athletes are recruited 3 months post ACL surgery. The level of confidence, symptoms, functional recovery level and muscle strength are assessed and compared between the two groups at 3, 4, 5, 6 and 9-month post surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

It is experimental research with pre-post repeated measure with a control group. The subjects are randomised either in the intervention group (Gr PRORO-UL) or the control group (Gr CHU-CP). The assessor is blinded to the randomisation. Both groups receive their program at the first assessment at three months post-ACL-surgery. They are strongly encouraged to continue their follow-up in physiotherapy to ensure the program is suitable to their individual progression. The participants are assessed again at 4, 5, 6 and 9 months post surgery to measure their progression. A weekly journal sent by e-mail is to be filled to ensure the subjects train according to their program attribution. It is a randomised control trial with a blinded assessor.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
      • Québec, Canada, G1V 0A6
        • Recruiting
        • Université Laval
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Amateur athlete aged from 18 to 35 years old doing sports at least 3 times a week
  • Having suffered from an Anterior Cruciate Ligament rupture
  • Having undergone Anterior Cruciate Ligament surgery either with an anterior approach (with the patellar tendon) or a posterior approach (with the semitendinosus tendon)
  • Having a functional deficit (score 85% or under at Knee Outcome Survey - Activity of Daily Living Scale questionnaire and/or score 80% or under at International Knee Documentation Committee questionnaire)
  • Being available for follow up and actively follow the programme attributed.

Exclusion Criteria:

  • Having suffered from multiple surgery for other ligaments in the same knee.
  • Having undergone total meniscus removal
  • Having suffered form Posterior Cruciate Ligament rupture.
  • Having other injuries that could affect the functional performance and prevent from training.

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Rouge et Or program
Rouge et Or program group follow a detailed program that they do on their own. It is made of three cycles of four weeks each. Every cycle contains 3 training sessions by week with a minimum of 24 hours between sessions. The training volume is modulated for every cycle and every week. Each training sessions is made of 6 warm-up exercises followed by 6 training exercises. The exercises are a mix of strengthening, endurance, plyometric, neuromuscular control and dynamic stability. The exercises change every month with a progressively increasing difficulty towards the end to mimic return to sport demands.
Other: Rouge et Or Program
It is a detailed, structured and precise training program. It is used from the third-month post ACL surgery to the sixth month.
Other Names:
  • (Gr PRORO-UL)
  • Programme du rouge et Or
  • Laval University Rouge et Or program
ACTIVE_COMPARATOR: CHU intervention guide
CHU intervention guide group follow the standard CHU protocol. At three months post-surgery, the protocol suggests progressing the exercises without precisely suggesting exercise, parameter or frequency.
Other: CHU intervention guide
From the third month to the sixth month, it outlines the progression to have in the training without precise information on exercises, parameter or frequency.
Other Names:
  • Programme du CHU
  • (Gr CHU-CP)
  • CHU program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Knee Outcome Survey-Activity of Daily Living Scale
Time Frame: 3, 4, 5, 6 and 9 months post-surgery
Questionnaire ranging from 0 to 70 over 70 where 70 means no limitation in activity of daily living. There is 14 questions with each graded answer providing 0 to 5 points that are summed together and expressed in percentage. The higher is the score, the better is the outcome.
3, 4, 5, 6 and 9 months post-surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Numerical Pain Rating Scale
Time Frame: 3 months post surgery
Four questions related to pain that are graded from 0 to 10. The lower is the score, the better is the outcome.
3 months post surgery
Numerical Pain Rating Scale
Time Frame: 4 months post-surgery
Four questions related to pain that are graded from 0 to 10. The lower is the score, the better is the outcome.
4 months post-surgery
Numerical Pain Rating Scale
Time Frame: 5 months post-surgery
Four questions related to pain that are graded from 0 to 10. The lower is the score, the better is the outcome.
5 months post-surgery
Numerical Pain Rating Scale
Time Frame: 6 months post-surgery
Four questions related to pain that are graded from 0 to 10. The lower is the score, the better is the outcome.
6 months post-surgery
Numerical Pain Rating Scale
Time Frame: 9 months post-surgery
Four questions related to pain that are graded from 0 to 10. The lower is the score, the better is the outcome.
9 months post-surgery
Change in Anterior Cruciate Ligament Return to Sport Index
Time Frame: 3, 4, 5, 6 and 9 months post-surgery
12 questions related to return to sport confidence graded from 0 to 10. All scores are summed together and expressed in percentage.The higher the score the better is the outcome.
3, 4, 5, 6 and 9 months post-surgery
Change in International knee documentation committee
Time Frame: 3, 4, 5, 6 and 9 months post-surgery
International knee documentation committee is a 10 items questionnaire measuring knee functional limitation. All items are summed and the total score range from 18 to 105. From that score we subtract 18 and divide by 87 and bring the score back in percentage. The final score can range from 0 to 100% where a higher score represents a better outcome.
3, 4, 5, 6 and 9 months post-surgery
Muscle strength
Time Frame: 3 months post-surgery
Isometric flexion and extension strength is measured with a handheld dynamometer.
3 months post-surgery
Muscle strength
Time Frame: 4 months post-surgery
Isometric flexion and extension strength is measured with a handheld dynamometer.
4 months post-surgery
Muscle strength
Time Frame: 5 months post-surgery
Isometric flexion and extension strength is measured with a handheld dynamometer.
5 months post-surgery
Muscle strength
Time Frame: 6 months post-surgery
Isometric flexion and extension strength is measured with a handheld dynamometer.
6 months post-surgery
Muscle strength
Time Frame: 9 months post-surgery
Isometric flexion and extension strength is measured with a handheld dynamometer.
9 months post-surgery
Muscle strength
Time Frame: 6 months post-surgery.
Concentric isokinetic flexion and extension strength is measured with Biodex at speed 60 degree/sec.
6 months post-surgery.
Muscle strength
Time Frame: 9 months post-surgery.
Concentric isokinetic flexion and extension strength is measured with Biodex at speed 60 degree/sec.
9 months post-surgery.
Single leg hop test.
Time Frame: 3 months post-surgery
The single-leg hop test is performed barefoot. The subjects are asked to jump as far as possible on one leg and to land keeping their balance. Measurement is made from the starting line to the place where the heel lands. The subjects must start behind the line. They perform one practice and three trials. The best trial is kept. The healthy limb is tested first followed by the injured leg.
3 months post-surgery
Single leg hop test.
Time Frame: 4 months post-surgery
The single-leg hop test is performed barefoot. The subjects are asked to jump as far as possible on one leg and to land keeping their balance. Measurement is made from the starting line to the place where the heel lands. The subjects must start behind the line. They perform one practice and three trials. The best trial is kept. The healthy limb is tested first followed by the injured leg.
4 months post-surgery
Single leg hop test.
Time Frame: 5 months post-surgery
The single-leg hop test is performed barefoot. The subjects are asked to jump as far as possible on one leg and to land keeping their balance. Measurement is made from the starting line to the place where the heel lands. The subjects must start behind the line. They perform one practice and three trials. The best trial is kept. The healthy limb is tested first followed by the injured leg.
5 months post-surgery
Single leg hop test.
Time Frame: 6 months post-surgery
The single-leg hop test is performed barefoot. The subjects are asked to jump as far as possible on one leg and to land keeping their balance. Measurement is made from the starting line to the place where the heel lands. The subjects must start behind the line. They perform one practice and three trials. The best trial is kept. The healthy limb is tested first followed by the injured leg.
6 months post-surgery
Single leg hop test.
Time Frame: 9 months post-surgery
The single-leg hop test is performed barefoot. The subjects are asked to jump as far as possible on one leg and to land keeping their balance. Measurement is made from the starting line to the place where the heel lands. The subjects must start behind the line. They perform one practice and three trials. The best trial is kept. The healthy limb is tested first followed by the injured leg.
9 months post-surgery
Triple hop test.
Time Frame: 3 months post-surgery
The Triple hop test is performed barefoot. The subjects are asked to jump on one leg three times in a row in one direction and to land the third jump in balance as far as possible. Measurement is made from the starting line to the place where the heel lands the third jump. The subjects must start behind the line. They perform one practice and three trial. The best trial is kept. The healthy limb is tested first followed by the injured leg.
3 months post-surgery
Triple hop test.
Time Frame: 4 months post-surgery
The Triple hop test is performed barefoot. The subjects are asked to jump on one leg three times in a row in one direction and to land the third jump in balance as far as possible. Measurement is made from the starting line to the place where the heel lands the third jump. The subjects must start behind the line. They perform one practice and three trial. The best trial is kept. The healthy limb is tested first followed by the injured leg.
4 months post-surgery
Triple hop test.
Time Frame: 5 months post-surgery
The Triple hop test is performed barefoot. The subjects are asked to jump on one leg three times in a row in one direction and to land the third jump in balance as far as possible. Measurement is made from the starting line to the place where the heel lands the third jump. The subjects must start behind the line. They perform one practice and three trial. The best trial is kept. The healthy limb is tested first followed by the injured leg.
5 months post-surgery
Triple hop test.
Time Frame: 6 months post-surgery
The Triple hop test is performed barefoot. The subjects are asked to jump on one leg three times in a row in one direction and to land the third jump in balance as far as possible. Measurement is made from the starting line to the place where the heel lands the third jump. The subjects must start behind the line. They perform one practice and three trial. The best trial is kept. The healthy limb is tested first followed by the injured leg.
6 months post-surgery
Triple hop test.
Time Frame: 9 months post-surgery
The Triple hop test is performed barefoot. The subjects are asked to jump on one leg three times in a row in one direction and to land the third jump in balance as far as possible. Measurement is made from the starting line to the place where the heel lands the third jump. The subjects must start behind the line. They perform one practice and three trial. The best trial is kept. The healthy limb is tested first followed by the injured leg.
9 months post-surgery
30 seconds side hop test
Time Frame: 3 months post-surgery
The 30 seconds side hop test is performed barefoot. The subjects are asked to jump side to side on one leg as many time as possible during 30 seconds over a 40 cm distance separated by two lines. Each time the foot of the subjet touch one line, the repetition is not recorded. The number of jumps is recorded. They perform two practice jumps and one 30 secondes trial. The healthy limb is tested first followed by the injured leg.
3 months post-surgery
30 seconds side hop test
Time Frame: 4 months post-surgery
The 30 seconds side hop test is performed barefoot. The subjects are asked to jump side to side on one leg as many time as possible during 30 seconds over a 40 cm distance separated by two lines. Each time the foot of the subjet touch one line, the repetition is not recorded. The number of jumps is recorded. They perform two practice jumps and one 30 secondes trial. The healthy limb is tested first followed by the injured leg.
4 months post-surgery
30 seconds side hop test
Time Frame: 5 months post-surgery
The 30 seconds side hop test is performed barefoot. The subjects are asked to jump side to side on one leg as many time as possible during 30 seconds over a 40 cm distance separated by two lines. Each time the foot of the subjet touch one line, the repetition is not recorded. The number of jumps is recorded. They perform two practice jumps and one 30 secondes trial. The healthy limb is tested first followed by the injured leg.
5 months post-surgery
30 seconds side hop test
Time Frame: 6 months post-surgery
The 30 seconds side hop test is performed barefoot. The subjects are asked to jump side to side on one leg as many time as possible during 30 seconds over a 40 cm distance separated by two lines. Each time the foot of the subjet touch one line, the repetition is not recorded. The number of jumps is recorded. They perform two practice jumps and one 30 secondes trial. The healthy limb is tested first followed by the injured leg.
6 months post-surgery
30 seconds side hop test
Time Frame: 9 months post-surgery
The 30 seconds side hop test is performed barefoot. The subjects are asked to jump side to side on one leg as many time as possible during 30 seconds over a 40 cm distance separated by two lines. Each time the foot of the subjet touch one line, the repetition is not recorded. The number of jumps is recorded. They perform two practice jumps and one 30 secondes trial. The healthy limb is tested first followed by the injured leg.
9 months post-surgery
Global Rating Of Change
Time Frame: 4 months post-surgery
A 15 item scale to grade the change from the initial data collection.
4 months post-surgery
Global Rating Of Change
Time Frame: 5 post-surgery
A 15 item scale to grade the change from the initial data collection.
5 post-surgery
Global Rating Of Change
Time Frame: 6 post-surgery
A 15 item scale to grade the change from the initial data collection.
6 post-surgery
Global Rating Of Change
Time Frame: 9 post-surgery
A 15 item scale to grade the change from the initial data collection.
9 post-surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laval University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Luc J. Hébert, 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACL readaptation LavalU

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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