Laval University Rouge et or Post ACL Surgery Program Effectiveness

NCT ID: NCT04137003

Last Updated: 2019-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-06

Study Completion Date

2020-09-01

Brief Summary

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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

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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.

Conditions

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Anterior Cruciate Ligament Injuries ACL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experimental research with pre-post repeated measures with a control group. It is a randomised control trial with a blinded assessor
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Rouge et Or Program

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

CHU intervention guide

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Other Intervention Names

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(Gr PRORO-UL) Programme du rouge et Or Laval University Rouge et Or program Programme du CHU (Gr CHU-CP) CHU program

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laval University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luc J. Hébert, PHD

Role: STUDY_DIRECTOR

Laval University

Locations

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Université Laval

Québec, , Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Luc J. Hébert, PHD

Role: CONTACT

418-529-9141 ext. 6579

Maxime Provencher, Maîtrise

Role: CONTACT

4189538818

Facility Contacts

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Maxime Provencher

Role: primary

418-656-5501

Other Identifiers

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ACL readaptation LavalU

Identifier Type: -

Identifier Source: org_study_id

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