Laval University Rouge et or Post ACL Surgery Program Effectiveness

NCT04137003 | Unknown

• 1 other identifier: ACL readaptation LavalU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Acl; Anterior cruciate ligament; Post surgery

Outcome Measures

Primary Outcomes (1)

• Change in Knee Outcome Survey-Activity of Daily Living Scale

  Questionnaire ranging from 0 to 70 over 70 where 70 means no limitation in activity of daily living. There is 14 questions with each graded answer providing 0 to 5 points that are summed together and expressed in percentage. The higher is the score, the better is the outcome.

  3, 4, 5, 6 and 9 months post-surgery

Secondary Outcomes (33)

• Numerical Pain Rating Scale

  3 months post surgery

• Numerical Pain Rating Scale

  4 months post-surgery

• Numerical Pain Rating Scale

  5 months post-surgery

• Numerical Pain Rating Scale

  6 months post-surgery

• Numerical Pain Rating Scale

  9 months post-surgery

Study Arms (2)

Rouge et Or program

EXPERIMENTAL

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.

Other: Rouge et Or Program

CHU intervention guide

ACTIVE COMPARATOR

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.

Other: CHU intervention guide

Interventions

Rouge et Or Program OTHER

It is a detailed, structured and precise training program. It is used from the third-month post ACL surgery to the sixth month.

Also known as: (Gr PRORO-UL), Programme du rouge et Or, Laval University Rouge et Or program

Rouge et Or program

CHU intervention guide OTHER

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.

Also known as: Programme du CHU, (Gr CHU-CP), CHU program

CHU intervention guide

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Université Laval

Québec, G1V 0A6, Canada

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Luc J. Hébert, PHD

  Laval University

  STUDY DIRECTOR

Central Study Contacts

Luc J. Hébert, PHD

CONTACT

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

Maxime Provencher, Maîtrise

CONTACT

4189538818; mprovencher@live.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Subjects are randomised to one of the two groups: Rouge et or program or Chu protocol. The assessor that perform the multiple assessments is blinded to the randomisation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental research with pre-post repeated measures with a control group. It is a randomised control trial with a blinded assessor

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: October 23, 2019
• Study Start: March 6, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 28, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)