- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06829849
Validity of the SHD-LESS Scale After ACL Reconstruction (ACL-LESS)
Validity of the SHD-LESS Scale in Detecting Landing Asymmetry and Its Association With Functional Status After ACL Reconstruction.
After anterior cruciate ligament reconstruction (ACL-R), Single Hop for Distance (SHD) performance aids in decision-making, particularly for return-to-sport assessments. However, asymmetrical landing kinematics are common after ACL-R, even with symmetrical performances, and increase the risk of re-injury. To support clinical practice, several qualitative scales have been developed as valid and reliable tools for assessing landing quality. In 2022, Measson et al. adapted the Landing Error Scoring System for use during an SHD task (SHD-LESS scale) and demonstrated its reliability among healthy individuals.
The aim of this study is to test the validity of this scale after ACL-R by evaluating its ability to identify asymmetrical landing and characterize differences between the operated and uninjured limb. The second objective is to assess its association with knee muscle strength, functional status and psychological readiness.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Caen, France
- Service de Médecine du sport, CHU Caen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
- Inability to perform a muscular assessment
- Postoperative complications (deep vein thrombosis, sepsis, stiffness/arthrofibrosis)
- Neurological history with residual effects or taking medication that affects balance/coordination
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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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Participants will perform a 2D-camera-recorded SHD task, with the SHD-LESS scored by two sports medicine physicians.
Additional tests include isokinetic muscle testing, as well as functional and psychological status assessments, following standard clinical practice.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Single Hop for Distance, Landing Error Scoring System (SHD-LESS) scale
Time Frame: One measurement during the visit at 6 to 12 months after surgery
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The LESS (Landing Error Scoring System) scale is a 13-item tool used to assess landing technique during a hop task.
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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 |
|---|---|---|
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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
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The ACL-RSI measures the patient's understanding of his knee.
It comprises 12 questions with a score of 1 to 10 for each
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One measurement during the visit at 6 to 12 months after surgery
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Strength
Time Frame: One measurement during the visit at 6 to 12 months after surgery
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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
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International Knee Documentation Committee (IKDC) score
Time Frame: One measurement during the visit at 6 to 12 months after surgery
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Knee level of function based on patient-reported measures from symptoms to daily activities.
The IKDC score includes sections on knee symptoms (7 items), function (2 items), and sports activities (2 items), with scores ranging from 0 (lowest function, highest symptoms) to 100 (highest function, lowest symptoms).
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One measurement during the visit at 6 to 12 months after surgery
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Measson MV, Ithurburn MP, Rambaud AJ. Intra-rater Reliability of a Qualitative Landing Scale for the Single-Hop Test: A Pilot Study. Int J Sports Phys Ther. 2022 Apr 1;17(3):493-500. doi: 10.26603/001c.33066. eCollection 2022.
- Welling W, Benjaminse A, Seil R, Lemmink K, Gokeler A. Altered movement during single leg hop test after ACL reconstruction: implications to incorporate 2-D video movement analysis for hop tests. Knee Surg Sports Traumatol Arthrosc. 2018 Oct;26(10):3012-3019. doi: 10.1007/s00167-018-4893-7. Epub 2018 Mar 16.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- ACL-LESS
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
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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