- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06524869
Association Between Neuromuscular Parameters and Functional Assessment After ACL Reconstruction (KASTLAB)
Association of Strength and Proprioception Parameters With Qualitative Assessment of Functional Tasks After ACL Reconstruction
The anterior cruciate ligament (ACL) injury is common in athletes aged 18 to 35. ACL reconstruction (ACLR) aims to restore knee stability in the process of returning to sports. Post-surgical rehabilitation focuses on optimizing biomechanical parameters, with neuromuscular and functional tests assessing muscle strength, proprioception, and dynamic stability. Isokinetic allows the measurement of muscle strength symmetry and proprioception, while the single-leg hop and landing tasks assess functional stability and are predictive of sports resumption and injury prevention. Despite progress, concerns remain about neuromuscular factors impacting knee stability, especially during landings, which can increase the risk of secondary ACL injuries.
This study proposes examining knee strength and proprioception using isokinetic dynamometry, alongside biomechanical assessments from functional tests, to explore their relationship to biomechanical features during landings, at 6-to-12 months post-ACL reconstruction. The hypothesis is that better muscle strength and proprioception correlate with improved knee control during landing tasks.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
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Caen, France, 14000
- Recruiting
- CHU Caen Normandie
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Contact:
- Joffrey Drigny, MD MSC
- Phone Number: +33231064533
- Email: drigny-j@chu-caen.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients, aged 18-40, who have undergone a first ACL reconstruction more than 6 months ago and are being followed in a sports medicine care pathway
- Affiliated with a health insurance plan
- Information form: Non-objection to the use of data for research purposes
Exclusion Criteria:
- Previous ligament surgery of the lower limbs prior to ACL reconstruction
- Complex ligament injury (lateral ligaments, posterior cruciate ligament)
- Recent muscle injuries
- History of injury to the uninjured knee
- Pregnant woman
- Neurological history with residual effects or taking medication that affects balance/coordination
- Inability to perform a muscular assessment
- Postoperative complications (deep vein thrombosis, sepsis, stiffness/arthrofibrosis)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ACL reconstruction group
All sports patients who had a muscle evaluation at 6 to 12 months after ACLR since March 2024
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All sports patients who had a muscle evaluation in addition to functional testing at 6-12 months after ACLR since March 2024
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Passive proprioceptive evaluation
Time Frame: One measurement during the visit at 6 to 12 months after surgery
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Measurement of knee proprioception by the passive repositioning technique (JPS, in degrees) on isokinetic dynamometer.
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One measurement during the visit at 6 to 12 months after surgery
|
|
Strength
Time Frame: One measurement during the visit at 6 to 12 months after surgery
|
Measurement of knee extensors and flexors peak strength (in newton.meter,
Nm) on isokinetic dynamometer.
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One measurement during the visit at 6 to 12 months after surgery
|
|
Single Hop test
Time Frame: One measurement during the visit at 6 to 12 months after surgery
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Measurement of knee position during landing from a single leg hop task
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One measurement during the visit at 6 to 12 months after surgery
|
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Single-leg landing task
Time Frame: One measurement during the visit at 6 to 12 months after surgery
|
Measurement of knee position during landing from a 30-cm box
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One measurement during the visit at 6 to 12 months after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Single Hop for Distance
Time Frame: One measurement during the visit at 6 to 12 months after surgery
|
The total distance is recorded (in cm)
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One measurement during the visit at 6 to 12 months after surgery
|
|
ACL-RSI questionnaire (Anterior Cruciate Ligament-Return to Sport after Injury)
Time Frame: One measurement during the visit at 6 to 12 months after surgery
|
The ACL-RSI measures the patient's understanding of his knee.
It comprises 12 questions with a score of 1 to 10 for each
|
One measurement during the visit at 6 to 12 months after surgery
|
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Landing Error Scoring System (LESS)
Time Frame: One measurement during the visit at 6 to 12 months after surgery
|
The LESS (Landing Error Scoring System) scale is a 13-item tool used to assess landing technique during a hop task.
|
One measurement during the visit at 6 to 12 months after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KASTLAB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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