Recruiting

ACL Surgery Program

Sponsor:

Laval University

Code:

NCT04137003

Conditions

Anterior Cruciate Ligament Injuries

ACL

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

Interventions

Rouge et Or Program

CHU intervention guide

Study Details

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.

Conditions

Anterior Cruciate Ligament Injuries

ACL

Study ID

NCT04137003

Start date

Mar 6, 2019

Status verified date

Oct, 2019

Completion date

Sep 1, 2020

Anticipated

Primary completion date

Sep 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Change in Knee Outcome Survey-Activity of Daily Living Scale [ Time Frame: 3, 4, 5, 6 and 9 months post-surgery ]

Central Contacts and Locations

Central contacts

Luc J. Hébert, PHD

418-529-9141lucj.hebert@fmed.ulaval.ca

Maxime Provencher, Maîtrise

4189538818mprovencher@live.ca

Locations

Université Laval

Recruiting

Québec, Canada, G1V 0A6

Contacts

Maxime Provencher

418-656-5501mprovencher@live.ca

More Information

Sponsor

Laval University

Last update posted

Oct 28, 2019

Last verified

Oct, 2019

Keywords

  • Acl
  • Anterior cruciate ligament
  • Post surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2019-10-28.