- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07659561
Assessment of Electromyographic Activity in the Quadriceps and Hamstrings of the Operated Limb Versus the Unaffected Limb in Patients Who Have Undergone ACL Surgery, With and Without Post-operative AMI - an Exploratory Study (AMIMYO)
Traumatic injuries to the knee joint, such as an anterior cruciate ligament tear, can compromise the ability of the muscle at the front of your thigh-known as the quadriceps-to contract voluntarily, despite the anatomical integrity of the nerve and muscle structures responsible for contraction. This phenomenon, commonly known as 'arthrogenic motor inhibition' (AMI), is a major limiting factor for recovery and rehabilitation following an anterior cruciate ligament tear, as well as a potential cause of functional disability if left undiagnosed and untreated. Indeed, motor inhibition that persists during the early months of rehabilitation could lead to under-activation of the quadriceps and over-activation of the hamstrings (the muscles at the back of your thigh).
It is of interest to assess, during the rehabilitation phase, the contraction capacity of the various quadriceps and hamstring muscles in the operated limb compared with the unaffected limb in patients who have undergone anterior cruciate ligament surgery and who experience post-operative motor inhibition, and in patients who have undergone anterior cruciate ligament surgery but do not experience post-operative motor inhibition. This is why this study has been initiated.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
An ACL tear and reconstruction can lead to a neurophysiological dysfunction commonly known as 'arthrogenic muscle inhibition' (AMI). This phenomenon impairs the ability to voluntarily activate the quadriceps, despite the anatomical integrity of the nerve and muscle structures responsible for contraction.
AMI is responsible for the quadriceps deficits observed following an ACL rupture and thus appears to be a major limiting factor in the patient's rehabilitation and functional recovery. Consequently, its diagnosis and treatment are imperative. The diagnosis of AMI (post-rupture and post-operative) is based on a classification system that categorises AMI diagnoses according to the identification of a deficit in activation of the vastus medialis (VM) alone (grade 1) or in combination with an extension deficit due to a grade 2 hamstring contracture (grade 2) (Sonnery-Cottet et al, 2022).
During the clinical examination, normal VM contraction (during relaxation) can be achieved without the recruitment of all motor units (minimal VM activation), and full knee extension (i.e. without reflex contraction of the hamstrings) can be restored without a return to adequate hamstring activation for the required task. Deficits in activation (inadequate activation) of the quadriceps and over-activation of the hamstrings (Hamstrings) during movements involving greater forces could be the consequences of an AMI still present in the early months of rehabilitation. This AMI could then disrupt the electromyographic (EMG) activation patterns of the quadriceps and hamstrings and contribute to long-term quadriceps deficits.
In this context, it is of interest to assess, during the rehabilitation phase, the EMG activity of the different muscle heads of the quadriceps and hamstrings in the operated limb versus the healthy limb in patients who have undergone ACL surgery and experienced post-operative IMA, and in patients who have undergone ACL surgery without post-operative IMA.
No studies have been published on this topic. This is why this research has been initiated.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bertrand SONNERY-COTTET, MD
- Phone Number: + 33 4 37 53 00 22
- Email: sonnerycottet@aol.com
Study Locations
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Lyon, France, 69008
- Hopital Prive Jean Mermoz
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Contact:
- Bertrand SONNERY-COTTET, MD
- Phone Number: + 33 4 37 53 00 22
- Email: sonnerycottet@aol.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient who has undergone ACL surgery at least 3 weeks ago
- Patient with no severe knee inflammation: stroke test ≤ 1+ and pain ≤ 3/10 (EN) at rest
- Patient with a Tegner score ≥ 5
- Patient with a Marx score ≥ 8
- Patient with or without a diagnosis of subjective AMI (Sonnery-Cottet et al. classification)
- French-speaking patients who do not object to the use of their data
Exclusion Criteria:
- Patient with a previous injury or surgery to the same or opposite knee
- Patient with a multi-ligament injury
- Patient with an AMI > grade 2b (Sonnery-Cottet et al. classification)
- Patient with a BMI > 30
- Pregnant or breastfeeding woman
- Patient with previous or current neurological and cardiovascular disorders or diseases
- Patient under legal protection: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: ACL Arm
Patient with ACL rupture
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Surface EMG of the quadriceps (vastus medialis, vastus lateralis and vastus longus) and the semimembranosus and biceps femoris muscles of the hamstrings on both the affected and unaffected sides, to objectively assess quadriceps inhibition.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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EMG activity
Time Frame: Month 3
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The average amplitude of EMG activity in the VM (Vastus Medialis) is assessed using the Root Mean Square (RMS) value, which is expressed in millivolts (mV).
The RMS is recorded using surface electrodes placed on the vastus medialis.
The primary outcome measure (activation deficit) is the absolute difference in RMS between the operated leg and the unaffected leg.
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Month 3
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-A00008-43
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
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