Activation Failure of Knee Extensors After Anterior Cruciate Ligament Rupture Depending on the Contraction Mode
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorLa Tour Hospital
About this trial
The primary objective of the study is to evaluate the impact of ACL injury and ACL reconstruction on voluntary activation during maximal voluntary contraction (measured by neurophysiological parameters) according to the contraction mode.
The goal is to provide elements of knowledge to clinicians about the mechanisms of the activation failure depending on contraction mode, but also the resulting adapted clinical recommendations for conducting rehabilitation, and particularly for the use of different contraction modes.
The main hypothesis is that activation failure is not equal according to the contraction mode during maximal voluntary contractions and neurophysiological parameters will be decreased in comparison with non-injured subjects.
Secondary objectives are:
* To analyze the evolution of neurophysiological parameters between sessions interspaced by several months according to the contraction mode. * To observe this time evolution depending on the treatment strategy chosen: rehabilitation or surgery plus rehabilitation.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age between 18 and 50 years
Free, informed consent signed by the participant and the investigator.
Session 1: Delay of 2 to 6 weeks after injury, with a quiet knee (range of motion 110- 0°, minimal effusion, maximal contraction pain ≤ 2/10)
Session 2: Duration of 36 to 42 weeks after injury, with a quiet knee (range of motion 110-0°, minimal effusion, maximal contraction pain ≤ 2/10)
Disqualifiers
1. Subjects fitted with an implanted electronic device such as a cardiac pacemaker 2. Professional athlete 3. Pregnant women 4. Subject with systemic pathology or treatment affecting the musculoskeletal system 5. Subject with a history of neurological pathology or traumatic pathology, or pathology that required orthopedic treatment and/or surgery of the knee, hip and/or lumbar spine 6. Contraindication to isokinetic testing: incapacitating pain, evolving pathological process, non- healed fracture, unbalanced cardiovascular pathology (angina pectoris, arterial hypertension) 7. Contralateral knee injury 8. Subject inability to follow procedures or insufficient knowledge of project language 9. Data acquisition issue or injury during testing
Trial population
The study population will comprise both male and female subjects, divided into three groups. The first group will consist of 20 subjects with isolated (only ACL rupture) or non-isolated ACL rupture (rupture associated with other knee lesion), treated with rehabilitation. The second group will include 20 subjects with ACL rupture, treated with surgery and rehabilitation. A third control group will also be included.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 3 trial groupsGroup A: Control
Group B: ACL - rehabilitation
Group C: ACL - surgery + rehabilitation
Trial outcomes
Primary outcomes
1
Voluntary Activation Level
Time frame
Between 2 and 6 weeks after ACL ruptureSecondary outcomes
1
Maximal voluntary torque
Time frame
between 2 to 6 weeks after ACL rupture2
EMG activity of vastus lateralis, vastus medialis and rectus femoris
Quantified with root mean square (RMS), normalized to the maximal M-wave
Time frame
between 2 to 6 weeks after ACL rupture3
Voluntary Activation Level
Time frame
Around 9 months after ACL rupture4
Maximal voluntary torque
Time frame
Around 9 months after ACL ruptureLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
La Tour Hospital
Lead sponsor
Toulouse NeuroImaging Center (ToNIC - UMR 1214 Inserm/UPS)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: