Neuromuscular Profiles After Anterior Cruciate Ligament Reconstruction
ConditionAnterior Cruciate Ligament Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHopitaux de Saint-Maurice
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Anterior cruciate ligament (ACL) reconstruction.
Postoperative period between 4 and 12 months.
Age 18 years or older.
Affiliation with or beneficiary of a social security scheme.
Disqualifiers
Persons under guardianship, curatorship, or another legal protection measure.
Any condition preventing safe performance of isokinetic testing, including significant pain, significant joint effusion, substantial limitation of joint range of motion, clinical knee instability, or an ongoing postoperative complication.
Opposition to participation in the study.
Trial population
Adults who underwent anterior cruciate ligament (ACL) reconstruction and are evaluated between 4 and 12 months postoperatively during a routine functional assessment at the study site.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Neuromuscular and Patient-Reported Assessmen
Other interventionSurface 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Patients After ACL Reconstruction1 intervention
Trial outcomes
Primary outcomes
1
Distribution of Neuromuscular Profiles
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 reconstructionSecondary outcomes
1
Surface Electromyographic Activity During the Single Leg Hop for Distance
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 reconstruction2
Distribution of Participants Across Neuromuscular Profile
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 reconstruction3
Correlation Between Neuromuscular Parameters and Functional and Patient-Reported Outcomes
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 reconstruction4
Completeness of Neuromuscular and Functional Assessment Data
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.
Time frame
During the single study visit, between 4 and 12 months after ACL reconstructionSponsors and contacts
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Source ClinicalTrials.gov