Back to resultsLaval University Rouge et or Post ACL Surgery Program Effectiveness
Primary Purpose
Anterior Cruciate Ligament Injuries, ACL
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Rouge et Or Program
CHU intervention guide
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Injuries focused on measuring Acl, Anterior cruciate ligament, Post surgery
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.
Sites / Locations
- Université LavalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rouge et Or program
CHU intervention guide
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Numerical Pain Rating Scale
Four questions related to pain that are graded from 0 to 10. The lower is the score, the better is the outcome.
Numerical Pain Rating Scale
Four questions related to pain that are graded from 0 to 10. The lower is the score, the better is the outcome.
Numerical Pain Rating Scale
Four questions related to pain that are graded from 0 to 10. The lower is the score, the better is the outcome.
Numerical Pain Rating Scale
Four questions related to pain that are graded from 0 to 10. The lower is the score, the better is the outcome.
Numerical Pain Rating Scale
Four questions related to pain that are graded from 0 to 10. The lower is the score, the better is the outcome.
Change in Anterior Cruciate Ligament Return to Sport Index
12 questions related to return to sport confidence graded from 0 to 10. All scores are summed together and expressed in percentage.The higher the score the better is the outcome.
Change in International knee documentation committee
International knee documentation committee is a 10 items questionnaire measuring knee functional limitation. All items are summed and the total score range from 18 to 105. From that score we subtract 18 and divide by 87 and bring the score back in percentage. The final score can range from 0 to 100% where a higher score represents a better outcome.
Muscle strength
Isometric flexion and extension strength is measured with a handheld dynamometer.
Muscle strength
Isometric flexion and extension strength is measured with a handheld dynamometer.
Muscle strength
Isometric flexion and extension strength is measured with a handheld dynamometer.
Muscle strength
Isometric flexion and extension strength is measured with a handheld dynamometer.
Muscle strength
Isometric flexion and extension strength is measured with a handheld dynamometer.
Muscle strength
Concentric isokinetic flexion and extension strength is measured with Biodex at speed 60 degree/sec.
Muscle strength
Concentric isokinetic flexion and extension strength is measured with Biodex at speed 60 degree/sec.
Single leg hop test.
The single-leg hop test is performed barefoot. The subjects are asked to jump as far as possible on one leg and to land keeping their balance. Measurement is made from the starting line to the place where the heel lands. The subjects must start behind the line. They perform one practice and three trials. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Single leg hop test.
The single-leg hop test is performed barefoot. The subjects are asked to jump as far as possible on one leg and to land keeping their balance. Measurement is made from the starting line to the place where the heel lands. The subjects must start behind the line. They perform one practice and three trials. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Single leg hop test.
The single-leg hop test is performed barefoot. The subjects are asked to jump as far as possible on one leg and to land keeping their balance. Measurement is made from the starting line to the place where the heel lands. The subjects must start behind the line. They perform one practice and three trials. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Single leg hop test.
The single-leg hop test is performed barefoot. The subjects are asked to jump as far as possible on one leg and to land keeping their balance. Measurement is made from the starting line to the place where the heel lands. The subjects must start behind the line. They perform one practice and three trials. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Single leg hop test.
The single-leg hop test is performed barefoot. The subjects are asked to jump as far as possible on one leg and to land keeping their balance. Measurement is made from the starting line to the place where the heel lands. The subjects must start behind the line. They perform one practice and three trials. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Triple hop test.
The Triple hop test is performed barefoot. The subjects are asked to jump on one leg three times in a row in one direction and to land the third jump in balance as far as possible. Measurement is made from the starting line to the place where the heel lands the third jump. The subjects must start behind the line. They perform one practice and three trial. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Triple hop test.
The Triple hop test is performed barefoot. The subjects are asked to jump on one leg three times in a row in one direction and to land the third jump in balance as far as possible. Measurement is made from the starting line to the place where the heel lands the third jump. The subjects must start behind the line. They perform one practice and three trial. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Triple hop test.
The Triple hop test is performed barefoot. The subjects are asked to jump on one leg three times in a row in one direction and to land the third jump in balance as far as possible. Measurement is made from the starting line to the place where the heel lands the third jump. The subjects must start behind the line. They perform one practice and three trial. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Triple hop test.
The Triple hop test is performed barefoot. The subjects are asked to jump on one leg three times in a row in one direction and to land the third jump in balance as far as possible. Measurement is made from the starting line to the place where the heel lands the third jump. The subjects must start behind the line. They perform one practice and three trial. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Triple hop test.
The Triple hop test is performed barefoot. The subjects are asked to jump on one leg three times in a row in one direction and to land the third jump in balance as far as possible. Measurement is made from the starting line to the place where the heel lands the third jump. The subjects must start behind the line. They perform one practice and three trial. The best trial is kept. The healthy limb is tested first followed by the injured leg.
30 seconds side hop test
The 30 seconds side hop test is performed barefoot. The subjects are asked to jump side to side on one leg as many time as possible during 30 seconds over a 40 cm distance separated by two lines. Each time the foot of the subjet touch one line, the repetition is not recorded. The number of jumps is recorded. They perform two practice jumps and one 30 secondes trial. The healthy limb is tested first followed by the injured leg.
30 seconds side hop test
The 30 seconds side hop test is performed barefoot. The subjects are asked to jump side to side on one leg as many time as possible during 30 seconds over a 40 cm distance separated by two lines. Each time the foot of the subjet touch one line, the repetition is not recorded. The number of jumps is recorded. They perform two practice jumps and one 30 secondes trial. The healthy limb is tested first followed by the injured leg.
30 seconds side hop test
The 30 seconds side hop test is performed barefoot. The subjects are asked to jump side to side on one leg as many time as possible during 30 seconds over a 40 cm distance separated by two lines. Each time the foot of the subjet touch one line, the repetition is not recorded. The number of jumps is recorded. They perform two practice jumps and one 30 secondes trial. The healthy limb is tested first followed by the injured leg.
30 seconds side hop test
The 30 seconds side hop test is performed barefoot. The subjects are asked to jump side to side on one leg as many time as possible during 30 seconds over a 40 cm distance separated by two lines. Each time the foot of the subjet touch one line, the repetition is not recorded. The number of jumps is recorded. They perform two practice jumps and one 30 secondes trial. The healthy limb is tested first followed by the injured leg.
30 seconds side hop test
The 30 seconds side hop test is performed barefoot. The subjects are asked to jump side to side on one leg as many time as possible during 30 seconds over a 40 cm distance separated by two lines. Each time the foot of the subjet touch one line, the repetition is not recorded. The number of jumps is recorded. They perform two practice jumps and one 30 secondes trial. The healthy limb is tested first followed by the injured leg.
Global Rating Of Change
A 15 item scale to grade the change from the initial data collection.
Global Rating Of Change
A 15 item scale to grade the change from the initial data collection.
Global Rating Of Change
A 15 item scale to grade the change from the initial data collection.
Global Rating Of Change
A 15 item scale to grade the change from the initial data collection.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04137003
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 6, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laval University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries, ACL
Keywords
Acl, Anterior cruciate ligament, Post surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental research with pre-post repeated measures with a control group. It is a randomised control trial with a blinded assessor
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rouge et Or program
Arm Type
Experimental
Arm 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.
Arm Title
CHU intervention guide
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Rouge et Or Program
Other Intervention Name(s)
(Gr PRORO-UL), Programme du rouge et Or, Laval University Rouge et Or program
Intervention Description
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
Intervention Name(s)
CHU intervention guide
Other Intervention Name(s)
Programme du CHU, (Gr CHU-CP), CHU program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Knee Outcome Survey-Activity of Daily Living Scale
Description
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.
Time Frame
3, 4, 5, 6 and 9 months post-surgery
Secondary Outcome Measure Information:
Title
Numerical Pain Rating Scale
Description
Four questions related to pain that are graded from 0 to 10. The lower is the score, the better is the outcome.
Time Frame
3 months post surgery
Title
Numerical Pain Rating Scale
Description
Four questions related to pain that are graded from 0 to 10. The lower is the score, the better is the outcome.
Time Frame
4 months post-surgery
Title
Numerical Pain Rating Scale
Description
Four questions related to pain that are graded from 0 to 10. The lower is the score, the better is the outcome.
Time Frame
5 months post-surgery
Title
Numerical Pain Rating Scale
Description
Four questions related to pain that are graded from 0 to 10. The lower is the score, the better is the outcome.
Time Frame
6 months post-surgery
Title
Numerical Pain Rating Scale
Description
Four questions related to pain that are graded from 0 to 10. The lower is the score, the better is the outcome.
Time Frame
9 months post-surgery
Title
Change in Anterior Cruciate Ligament Return to Sport Index
Description
12 questions related to return to sport confidence graded from 0 to 10. All scores are summed together and expressed in percentage.The higher the score the better is the outcome.
Time Frame
3, 4, 5, 6 and 9 months post-surgery
Title
Change in International knee documentation committee
Description
International knee documentation committee is a 10 items questionnaire measuring knee functional limitation. All items are summed and the total score range from 18 to 105. From that score we subtract 18 and divide by 87 and bring the score back in percentage. The final score can range from 0 to 100% where a higher score represents a better outcome.
Time Frame
3, 4, 5, 6 and 9 months post-surgery
Title
Muscle strength
Description
Isometric flexion and extension strength is measured with a handheld dynamometer.
Time Frame
3 months post-surgery
Title
Muscle strength
Description
Isometric flexion and extension strength is measured with a handheld dynamometer.
Time Frame
4 months post-surgery
Title
Muscle strength
Description
Isometric flexion and extension strength is measured with a handheld dynamometer.
Time Frame
5 months post-surgery
Title
Muscle strength
Description
Isometric flexion and extension strength is measured with a handheld dynamometer.
Time Frame
6 months post-surgery
Title
Muscle strength
Description
Isometric flexion and extension strength is measured with a handheld dynamometer.
Time Frame
9 months post-surgery
Title
Muscle strength
Description
Concentric isokinetic flexion and extension strength is measured with Biodex at speed 60 degree/sec.
Time Frame
6 months post-surgery.
Title
Muscle strength
Description
Concentric isokinetic flexion and extension strength is measured with Biodex at speed 60 degree/sec.
Time Frame
9 months post-surgery.
Title
Single leg hop test.
Description
The single-leg hop test is performed barefoot. The subjects are asked to jump as far as possible on one leg and to land keeping their balance. Measurement is made from the starting line to the place where the heel lands. The subjects must start behind the line. They perform one practice and three trials. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Time Frame
3 months post-surgery
Title
Single leg hop test.
Description
The single-leg hop test is performed barefoot. The subjects are asked to jump as far as possible on one leg and to land keeping their balance. Measurement is made from the starting line to the place where the heel lands. The subjects must start behind the line. They perform one practice and three trials. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Time Frame
4 months post-surgery
Title
Single leg hop test.
Description
The single-leg hop test is performed barefoot. The subjects are asked to jump as far as possible on one leg and to land keeping their balance. Measurement is made from the starting line to the place where the heel lands. The subjects must start behind the line. They perform one practice and three trials. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Time Frame
5 months post-surgery
Title
Single leg hop test.
Description
The single-leg hop test is performed barefoot. The subjects are asked to jump as far as possible on one leg and to land keeping their balance. Measurement is made from the starting line to the place where the heel lands. The subjects must start behind the line. They perform one practice and three trials. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Time Frame
6 months post-surgery
Title
Single leg hop test.
Description
The single-leg hop test is performed barefoot. The subjects are asked to jump as far as possible on one leg and to land keeping their balance. Measurement is made from the starting line to the place where the heel lands. The subjects must start behind the line. They perform one practice and three trials. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Time Frame
9 months post-surgery
Title
Triple hop test.
Description
The Triple hop test is performed barefoot. The subjects are asked to jump on one leg three times in a row in one direction and to land the third jump in balance as far as possible. Measurement is made from the starting line to the place where the heel lands the third jump. The subjects must start behind the line. They perform one practice and three trial. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Time Frame
3 months post-surgery
Title
Triple hop test.
Description
The Triple hop test is performed barefoot. The subjects are asked to jump on one leg three times in a row in one direction and to land the third jump in balance as far as possible. Measurement is made from the starting line to the place where the heel lands the third jump. The subjects must start behind the line. They perform one practice and three trial. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Time Frame
4 months post-surgery
Title
Triple hop test.
Description
The Triple hop test is performed barefoot. The subjects are asked to jump on one leg three times in a row in one direction and to land the third jump in balance as far as possible. Measurement is made from the starting line to the place where the heel lands the third jump. The subjects must start behind the line. They perform one practice and three trial. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Time Frame
5 months post-surgery
Title
Triple hop test.
Description
The Triple hop test is performed barefoot. The subjects are asked to jump on one leg three times in a row in one direction and to land the third jump in balance as far as possible. Measurement is made from the starting line to the place where the heel lands the third jump. The subjects must start behind the line. They perform one practice and three trial. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Time Frame
6 months post-surgery
Title
Triple hop test.
Description
The Triple hop test is performed barefoot. The subjects are asked to jump on one leg three times in a row in one direction and to land the third jump in balance as far as possible. Measurement is made from the starting line to the place where the heel lands the third jump. The subjects must start behind the line. They perform one practice and three trial. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Time Frame
9 months post-surgery
Title
30 seconds side hop test
Description
The 30 seconds side hop test is performed barefoot. The subjects are asked to jump side to side on one leg as many time as possible during 30 seconds over a 40 cm distance separated by two lines. Each time the foot of the subjet touch one line, the repetition is not recorded. The number of jumps is recorded. They perform two practice jumps and one 30 secondes trial. The healthy limb is tested first followed by the injured leg.
Time Frame
3 months post-surgery
Title
30 seconds side hop test
Description
The 30 seconds side hop test is performed barefoot. The subjects are asked to jump side to side on one leg as many time as possible during 30 seconds over a 40 cm distance separated by two lines. Each time the foot of the subjet touch one line, the repetition is not recorded. The number of jumps is recorded. They perform two practice jumps and one 30 secondes trial. The healthy limb is tested first followed by the injured leg.
Time Frame
4 months post-surgery
Title
30 seconds side hop test
Description
The 30 seconds side hop test is performed barefoot. The subjects are asked to jump side to side on one leg as many time as possible during 30 seconds over a 40 cm distance separated by two lines. Each time the foot of the subjet touch one line, the repetition is not recorded. The number of jumps is recorded. They perform two practice jumps and one 30 secondes trial. The healthy limb is tested first followed by the injured leg.
Time Frame
5 months post-surgery
Title
30 seconds side hop test
Description
The 30 seconds side hop test is performed barefoot. The subjects are asked to jump side to side on one leg as many time as possible during 30 seconds over a 40 cm distance separated by two lines. Each time the foot of the subjet touch one line, the repetition is not recorded. The number of jumps is recorded. They perform two practice jumps and one 30 secondes trial. The healthy limb is tested first followed by the injured leg.
Time Frame
6 months post-surgery
Title
30 seconds side hop test
Description
The 30 seconds side hop test is performed barefoot. The subjects are asked to jump side to side on one leg as many time as possible during 30 seconds over a 40 cm distance separated by two lines. Each time the foot of the subjet touch one line, the repetition is not recorded. The number of jumps is recorded. They perform two practice jumps and one 30 secondes trial. The healthy limb is tested first followed by the injured leg.
Time Frame
9 months post-surgery
Title
Global Rating Of Change
Description
A 15 item scale to grade the change from the initial data collection.
Time Frame
4 months post-surgery
Title
Global Rating Of Change
Description
A 15 item scale to grade the change from the initial data collection.
Time Frame
5 post-surgery
Title
Global Rating Of Change
Description
A 15 item scale to grade the change from the initial data collection.
Time Frame
6 post-surgery
Title
Global Rating Of Change
Description
A 15 item scale to grade the change from the initial data collection.
Time Frame
9 post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luc J. Hébert, PHD
Phone
418-529-9141
Ext
6579
Email
lucj.hebert@fmed.ulaval.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Maxime Provencher, Maîtrise
Phone
4189538818
Email
mprovencher@live.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc J. Hébert, PHD
Organizational Affiliation
Laval University
Official's Role
Study Director
Facility Information:
Facility Name
Université Laval
City
Québec
ZIP/Postal Code
G1V 0A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxime Provencher
Phone
418-656-5501
Email
mprovencher@live.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Laval University Rouge et or Post ACL Surgery Program Effectiveness
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