Laval University Rouge et or Post ACL Surgery Program Effectiveness

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Brief Title

Laval University Rouge et or Post ACL Surgery Program Effectiveness

Official Title

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

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.
    

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


Primary Outcome

Change in Knee Outcome Survey-Activity of Daily Living Scale

Secondary Outcome

 Numerical Pain Rating Scale

Condition

Anterior Cruciate Ligament Injuries

Intervention

Rouge et Or Program

Study Arms / Comparison Groups

 Rouge et Or program
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

60

Start Date

March 6, 2019

Completion Date

September 1, 2020

Primary Completion Date

September 1, 2020

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 35 Years

Accepts Healthy Volunteers

No

Contacts

Luc J. Hébert, PHD, 418-529-9141, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT04137003

Organization ID

ACL readaptation LavalU


Responsible Party

Sponsor

Study Sponsor

Laval University


Study Sponsor

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


Verification Date

October 2019