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Laval University Rouge et or Post ACL Surgery Program Effectiveness

L

Laval University

Status

Unknown

Conditions

ACL
Anterior Cruciate Ligament Injuries

Treatments

Other: Rouge et Or Program
Other: CHU intervention guide

Study type

Interventional

Funder types

Other

Identifiers

NCT04137003
ACL readaptation LavalU

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Rouge et Or program
Experimental group
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.
Treatment:
Other: Rouge et Or Program
CHU intervention guide
Active Comparator group
Description:
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.
Treatment:
Other: CHU intervention guide

Trial contacts and locations

1

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Central trial contact

Luc J. Hébert, PHD; Maxime Provencher, Maîtrise

Data sourced from clinicaltrials.gov

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