Laval University Rouge et or Post ACL Surgery Program Effectiveness

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

Laval University Rouge et Or Post Anterior Cruciate Ligament Surgery Readaptation Program Effectiveness With Amateur Athletes: A Randomised Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04137003
• Other study ID #: ACL readaptation LavalU
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: October 2019
• Source: Laval University
• Contact: Luc J. Hébert, PHD
• Phone: 418-529-9141
• Email: lucj.hebert[@]fmed.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• ACL
• Anterior Cruciate Ligament Injuries

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Université Laval	Québec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	3 months post surgery
Secondary	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.	4 months post-surgery
Secondary	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.	5 months post-surgery
Secondary	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.	6 months post-surgery
Secondary	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.	9 months post-surgery
Secondary	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.	3, 4, 5, 6 and 9 months post-surgery
Secondary	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.	3, 4, 5, 6 and 9 months post-surgery
Secondary	Muscle strength	Isometric flexion and extension strength is measured with a handheld dynamometer.	3 months post-surgery
Secondary	Muscle strength	Isometric flexion and extension strength is measured with a handheld dynamometer.	4 months post-surgery
Secondary	Muscle strength	Isometric flexion and extension strength is measured with a handheld dynamometer.	5 months post-surgery
Secondary	Muscle strength	Isometric flexion and extension strength is measured with a handheld dynamometer.	6 months post-surgery
Secondary	Muscle strength	Isometric flexion and extension strength is measured with a handheld dynamometer.	9 months post-surgery
Secondary	Muscle strength	Concentric isokinetic flexion and extension strength is measured with Biodex at speed 60 degree/sec.	6 months post-surgery.
Secondary	Muscle strength	Concentric isokinetic flexion and extension strength is measured with Biodex at speed 60 degree/sec.	9 months post-surgery.
Secondary	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.	3 months post-surgery
Secondary	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.	4 months post-surgery
Secondary	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.	5 months post-surgery
Secondary	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.	6 months post-surgery
Secondary	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.	9 months post-surgery
Secondary	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.	3 months post-surgery
Secondary	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.	4 months post-surgery
Secondary	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.	5 months post-surgery
Secondary	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.	6 months post-surgery
Secondary	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.	9 months post-surgery
Secondary	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.	3 months post-surgery
Secondary	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.	4 months post-surgery
Secondary	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.	5 months post-surgery
Secondary	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.	6 months post-surgery
Secondary	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.	9 months post-surgery
Secondary	Global Rating Of Change	A 15 item scale to grade the change from the initial data collection.	4 months post-surgery
Secondary	Global Rating Of Change	A 15 item scale to grade the change from the initial data collection.	5 post-surgery
Secondary	Global Rating Of Change	A 15 item scale to grade the change from the initial data collection.	6 post-surgery
Secondary	Global Rating Of Change	A 15 item scale to grade the change from the initial data collection.	9 post-surgery