NCT07659561

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

1.1 years

First QC Date

June 15, 2026

Last Update Submit

June 15, 2026

Conditions

Keywords

ACL ruptureAMIelectromyographythigh

Outcome Measures

Primary Outcomes (1)

  • EMG activity

    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.

    Month 3

Study Arms (1)

ACL Arm

EXPERIMENTAL

Patient with ACL rupture

Behavioral: Electromyography

Interventions

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.

ACL Arm

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Privé Jean Mermoz

Lyon, 69008, France

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Central Study Contacts

Bertrand SONNERY-COTTET, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2026

First Posted

June 22, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

June 22, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations