Laval University Rouge et or Post ACL Surgery Program Effectiveness

Sponsor
Laval University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04137003
Collaborator
(none)
60
1
2
17.9
3.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Rouge et Or Program
  • Other: CHU intervention guide
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Experimental research with pre-post repeated measures with a control group. It is a randomised control trial with a blinded assessorExperimental research with pre-post repeated measures with a control group. It is a randomised control trial with a blinded assessor
Masking:
Single (Outcomes Assessor)
Masking Description:
Subjects are randomised to one of the two groups: Rouge et or program or Chu protocol. The assessor that perform the multiple assessments is blinded to the randomisation.
Primary Purpose:
Treatment
Official Title:
Laval University Rouge et Or Post Anterior Cruciate Ligament Surgery Readaptation Program Effectiveness With Amateur Athletes: A Randomised Clinical Trial
Actual Study Start Date :
Mar 6, 2019
Anticipated Primary Completion Date :
Sep 1, 2020
Anticipated Study Completion Date :
Sep 1, 2020

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Change in Knee Outcome Survey-Activity of Daily Living Scale [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.

    Secondary Outcome Measures

    1. Numerical Pain Rating Scale [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.

    2. Numerical Pain Rating Scale [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.

    3. Numerical Pain Rating Scale [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.

    4. Numerical Pain Rating Scale [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.

    5. Numerical Pain Rating Scale [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.

    6. Change in Anterior Cruciate Ligament Return to Sport Index [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.

    7. Change in International knee documentation committee [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.

    8. Muscle strength [3 months post-surgery]

      Isometric flexion and extension strength is measured with a handheld dynamometer.

    9. Muscle strength [4 months post-surgery]

      Isometric flexion and extension strength is measured with a handheld dynamometer.

    10. Muscle strength [5 months post-surgery]

      Isometric flexion and extension strength is measured with a handheld dynamometer.

    11. Muscle strength [6 months post-surgery]

      Isometric flexion and extension strength is measured with a handheld dynamometer.

    12. Muscle strength [9 months post-surgery]

      Isometric flexion and extension strength is measured with a handheld dynamometer.

    13. Muscle strength [6 months post-surgery.]

      Concentric isokinetic flexion and extension strength is measured with Biodex at speed 60 degree/sec.

    14. Muscle strength [9 months post-surgery.]

      Concentric isokinetic flexion and extension strength is measured with Biodex at speed 60 degree/sec.

    15. Single leg hop test. [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.

    16. Single leg hop test. [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.

    17. Single leg hop test. [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.

    18. Single leg hop test. [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.

    19. Single leg hop test. [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.

    20. Triple hop test. [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.

    21. Triple hop test. [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.

    22. Triple hop test. [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.

    23. Triple hop test. [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.

    24. Triple hop test. [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.

    25. 30 seconds side hop test [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.

    26. 30 seconds side hop test [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.

    27. 30 seconds side hop test [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.

    28. 30 seconds side hop test [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.

    29. 30 seconds side hop test [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.

    30. Global Rating Of Change [4 months post-surgery]

      A 15 item scale to grade the change from the initial data collection.

    31. Global Rating Of Change [5 post-surgery]

      A 15 item scale to grade the change from the initial data collection.

    32. Global Rating Of Change [6 post-surgery]

      A 15 item scale to grade the change from the initial data collection.

    33. Global Rating Of Change [9 post-surgery]

      A 15 item scale to grade the change from the initial data collection.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Université Laval Québec Canada G1V 0A6

    Sponsors and Collaborators

    • Laval University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Laval University
    ClinicalTrials.gov Identifier:
    NCT04137003
    Other Study ID Numbers:
    • ACL readaptation LavalU
    First Posted:
    Oct 23, 2019
    Last Update Posted:
    Oct 28, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Laval University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 28, 2019