Clinical trial NCT04137003: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
ACL
Keywords: Acl
Anterior cruciate ligament
Post surgery
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental research with pre-post repeated measures with a control group. It is a randomised control trial with a blinded assessor
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Knee Outcome Survey-Activity of Daily Living Scale
timeFrame: 3, 4, 5, 6 and 9 months post-surgery
Secondary outcomes:
measure: Numerical Pain Rating Scale
timeFrame: 3 months post surgery
measure: Numerical Pain Rating Scale
timeFrame: 4 months post-surgery
measure: Numerical Pain Rating Scale
timeFrame: 5 months post-surgery
measure: Numerical Pain Rating Scale
timeFrame: 6 months post-surgery
measure: Numerical Pain Rating Scale
timeFrame: 9 months post-surgery
measure: Change in Anterior Cruciate Ligament Return to Sport Index
timeFrame: 3, 4, 5, 6 and 9 months post-surgery
measure: Change in International knee documentation committee
timeFrame: 3, 4, 5, 6 and 9 months post-surgery
measure: Muscle strength
timeFrame: 3 months post-surgery
measure: Muscle strength
timeFrame: 4 months post-surgery
measure: Muscle strength
timeFrame: 5 months post-surgery
measure: Muscle strength
timeFrame: 6 months post-surgery
measure: Muscle strength
timeFrame: 9 months post-surgery
measure: Muscle strength
timeFrame: 6 months post-surgery.
measure: Muscle strength
timeFrame: 9 months post-surgery.
measure: Single leg hop test.
timeFrame: 3 months post-surgery
measure: Single leg hop test.
timeFrame: 4 months post-surgery
measure: Single leg hop test.
timeFrame: 5 months post-surgery
measure: Single leg hop test.
timeFrame: 6 months post-surgery
measure: Single leg hop test.
timeFrame: 9 months post-surgery
measure: Triple hop test.
timeFrame: 3 months post-surgery
measure: Triple hop test.
timeFrame: 4 months post-surgery
measure: Triple hop test.
timeFrame: 5 months post-surgery
measure: Triple hop test.
timeFrame: 6 months post-surgery
measure: Triple hop test.
timeFrame: 9 months post-surgery
measure: 30 seconds side hop test
timeFrame: 3 months post-surgery
measure: 30 seconds side hop test
timeFrame: 4 months post-surgery
measure: 30 seconds side hop test
timeFrame: 5 months post-surgery
measure: 30 seconds side hop test
timeFrame: 6 months post-surgery
measure: 30 seconds side hop test
timeFrame: 9 months post-surgery
measure: Global Rating Of Change
timeFrame: 4 months post-surgery
measure: Global Rating Of Change
timeFrame: 5 post-surgery
measure: Global Rating Of Change
timeFrame: 6 post-surgery
measure: Global Rating Of Change
timeFrame: 9 post-surgery
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Université Laval
Study officials:
affiliation: Laval University
name: Luc J. Hébert, PHD
role: STUDY_DIRECTOR
References: