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