Hôpitaux Paris Est Val-de-Marne - Service de rééducation orthopédique et traumatologie
Saint-Maurice, Demande, 94410, France
NCT Number: NCT07792863
The NEURO-ACL-ISOEMG study is an observational, cross-sectional, exploratory study conducted in patients between 4 and 12 months after anterior cruciate ligament (ACL) reconstruction.
The primary objective is to describe the joint distribution of isokinetic muscle strength and surface electromyographic (sEMG) activation parameters of the quadriceps and hamstrings in order to explore different neuromuscular profiles under clinical conditions.
The study combines data from the routine functional assessment, including isokinetic strength measurements and a single-leg hop test, with surface electromyography and patient-reported questionnaires assessing knee self-efficacy, kinesiophobia, symptoms, and knee function.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Saint-Maurice, Demande, 94410, France
Persistent muscle strength deficits are frequently observed after anterior cruciate ligament (ACL) reconstruction and may be related to both peripheral muscular factors and alterations in neuromuscular activation. However, few studies have simultaneously assessed isokinetic strength and electromyographic activation of both agonist and antagonist muscles under analytical and functional conditions.
NEURO-ACL-ISOEMG is a monocentric, observational, cross-sectional, exploratory study designed to characterize neuromuscular profiles in patients evaluated between 4 and 12 months after ACL reconstruction.
The primary objective is to describe the joint distribution of isokinetic muscle strength and surface electromyographic activation parameters of the quadriceps and hamstrings. Isokinetic assessment includes quadriceps and hamstring peak torque and the Limb Symmetry Index (LSI). Surface electromyography is used to assess activation of the vastus medialis, vastus lateralis, semitendinosus, and biceps femoris during standardized isometric contractions.
Secondary objectives include describing electromyographic patterns during a single-leg functional task, exploring the concordance between electromyographic parameters obtained under analytical and functional conditions, describing the distribution of patients according to different combinations of isokinetic strength and electromyographic activation, and exploring associations between neuromuscular profiles, functional performance, and psychological factors. The study also assesses the completeness and usability of data obtained from the functional assessment in routine clinical practice.
Participants undergo a single study visit during their routine functional assessment after ACL reconstruction. Routine assessment includes isokinetic strength measurements and a single-leg hop test. For the purposes of the study, surface electromyography and three patient-reported questionnaires are added: the Knee Self-Efficacy Scale (K-SES), the Tampa Scale for Kinesiophobia (TSK), and the International Knee Documentation Committee (IKDC) questionnaire.
The study does not modify the participants' therapeutic management and is not intended to establish an individual diagnosis. Its purpose is to provide an exploratory characterization of the heterogeneity of neuromuscular recovery after ACL reconstruction and to generate hypotheses that may contribute to the interpretation of functional assessments and future rehabilitation strategies.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surface electromyography of the quadriceps and hamstrings is performed using surface electrodes. Participants also complete the Knee Self-Efficacy Scale (K-SES), Tampa Scale for Kinesiophobia (TSK), and International Knee Documentation Committee (IKDC) questionnaire. These assessments are performed during the same visit as the routine functional assessment.
Time frame: During the single study visit, between 4 and 12 months after ACL reconstruction
Participants will be classified into neuromuscular profiles based on the combined pattern of isokinetic strength and surface electromyographic activation of the quadriceps and hamstrings. The primary outcome will be the proportion of participants belonging to each identified neuromuscular profile, expressed as a percentage of the study population.
Time frame: During the single study visit, between 4 and 12 months after ACL reconstruction
Surface electromyographic activity of the vastus medialis, vastus lateralis, semitendinosus, and biceps femoris recorded during the Single Leg Hop for Distance.
Time frame: During the single study visit, between 4 and 12 months after ACL reconstruction
Proportion of participants belonging to each neuromuscular profile defined from the observed combinations of isokinetic strength deficit and level of surface electromyographic activation.
Time frame: During the single study visit, between 4 and 12 months after ACL reconstruction
Correlations between neuromuscular parameters and functional and patient-reported outcomes will be assessed using correlation coefficients. Functional performance will be assessed using the Single Leg Hop for Distance. Patient-reported outcomes will include scores from the Knee Self-Efficacy Scale (K-SES), Tampa Scale for Kinesiophobia (TSK), and International Knee Documentation Committee (IKDC) questionnaire. Correlation coefficients will range from -1 to +1, with values closer to -1 or +1 indicating stronger correlations and values closer to 0 indicating weaker correlations.
Time frame: During the single study visit, between 4 and 12 months after ACL reconstruction
Percentage of participants with complete data available for the planned analyses, including isokinetic strength, surface electromyography, Single Leg Hop for Distance, and patient-reported questionnaire data. Data completeness will be calculated as the number of participants with complete datasets divided by the total number of participants included in the study, multiplied by 100.
Contact information is provided by the study sponsor or research team.
Auriane AS SLAMA
CONTACT
Sylvain SB BELOT, MD
CONTACT
Hopitaux de Saint-Maurice
Other
Exploratory Study of Neuromuscular Profiles After Anterior Cruciate Ligament Reconstruction in Clinical Conditions: Combined Analysis of Isokinetic Strength and Surface Electromyography
Acronym: NEURO-ACL-ISOE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07733895
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Injury
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07762989
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Injury
Çankaya, Ankara, Turkey (Türkiye)
View Trial DetailsNCT07643480
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Injury
View Trial DetailsNCT07523178
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Injury
Liège, Belgium
View Trial Details