Laval University Rouge et or Post ACL Surgery Program Effectiveness

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: Unknown
• Conditions: Anterior Cruciate Ligament Injuries; ACL
• Intervention / Treatment: Other: Rouge et Or Program; Other: CHU intervention guide

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: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luc J. Hébert, PHD; Phone Number: 6579 418-529-9141; Email: lucj.hebert@fmed.ulaval.ca
• Study Contact Backup: Name: Maxime Provencher, Maîtrise; Phone Number: 4189538818; Email: mprovencher@live.ca

Study Locations

• Canada
  • Québec, Canada, G1V 0A6
    • Recruiting
    • Universite Laval
    • Contact: Maxime Provencher; Phone Number: 418-656-5501; Email: mprovencher@live.ca

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in Knee Outcome Survey-Activity of Daily Living Scale	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

Outcome Measure	Measure Description	Time Frame
Numerical Pain Rating Scale	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	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	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	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	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	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	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	Isometric flexion and extension strength is measured with a handheld dynamometer.	3 months post-surgery
Muscle strength	Isometric flexion and extension strength is measured with a handheld dynamometer.	4 months post-surgery
Muscle strength	Isometric flexion and extension strength is measured with a handheld dynamometer.	5 months post-surgery
Muscle strength	Isometric flexion and extension strength is measured with a handheld dynamometer.	6 months post-surgery
Muscle strength	Isometric flexion and extension strength is measured with a handheld dynamometer.	9 months post-surgery
Muscle strength	Concentric isokinetic flexion and extension strength is measured with Biodex at speed 60 degree/sec.	6 months post-surgery.
Muscle strength	Concentric isokinetic flexion and extension strength is measured with Biodex at speed 60 degree/sec.	9 months post-surgery.
Single leg hop test.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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	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	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	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	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	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	A 15 item scale to grade the change from the initial data collection.	4 months post-surgery
Global Rating Of Change	A 15 item scale to grade the change from the initial data collection.	5 post-surgery
Global Rating Of Change	A 15 item scale to grade the change from the initial data collection.	6 post-surgery
Global Rating Of Change	A 15 item scale to grade the change from the initial data collection.	9 post-surgery

Collaborators and Investigators

• Sponsor: Laval University
• Investigators: Study Director: Luc J. Hébert, PHD, Laval University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 6, 2019
• Primary Completion (ANTICIPATED): September 1, 2020
• Study Completion (ANTICIPATED): September 1, 2020

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (ACTUAL): October 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2019
• Last Update Submitted That Met QC Criteria: October 25, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Anterior cruciate ligament; Acl; Post surgery
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID 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