Anterior Cruciate Ligament InjuryNEURO-ACL-ISOENCT07792863
Neuromuscular Profiles After Anterior Cruciate Ligament Reconstruction
An observational study of Anterior Cruciate Ligament Injury, run by Hopitaux de Saint-Maurice at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- Neuromuscular and Patient-Reported Assessmen
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 21 Aug 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
- Ability to understand the study information and to express non-opposition to participation.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Paris Est Val-de-Marne - Service de rééducation orthopédique et traumatologie
Saint-Maurice, Demande, 94410
Auriane AS SLAMA, +33143967556, auriane.slama@hpevm.fr
About this study
Official title: Exploratory Study of Neuromuscular Profiles After Anterior Cruciate Ligament Reconstruction in Clinical Conditions: Combined Analysis of Isokinetic Strength and Surface Electromyography
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.
Read the detailed description
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.
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- Neuromuscular and Patient-Reported Assessmen
- Keywords
- Anterior Cruciate Ligament Reconstruction, Neuromuscular Recovery, Isokinetic Strength, Surface Electromyography, Quadriceps, Hamstrings, Muscle Activation, Functional Assessment
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular and Patient-Reported AssessmenOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients After ACL Reconstruction | Adults evaluated between 4 and 12 months after anterior cruciate ligament (ACL) reconstruction as part of their routine functional assessment. Participants undergo isokinetic strength assessment and a single-leg hop test as part of routine care, complemented for the study by surface electromyography and patient-reported questionnaires assessing knee self-efficacy, kinesiophobia, symptoms, and knee function. Receives: Other: Neuromuscular and Patient-Reported Assessmen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the single study visit, between 4 and 12 months after ACL reconstruction
Secondary outcomes (4)
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.
Measured: During the single study visit, between 4 and 12 months after ACL reconstruction
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.
Measured: During the single study visit, between 4 and 12 months after ACL reconstruction
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.
Measured: During the single study visit, between 4 and 12 months after ACL reconstruction
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.
Measured: During the single study visit, between 4 and 12 months after ACL reconstruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start21 Aug 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopitaux de Saint-Maurice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain BS BELOT, md, Principal investigator, Hopitaux Paris Est Val-de-Marne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792863
- Sponsor's protocol ID
- NEURO-ACL-ISOEMG
- Other IDs
- 2026-A01124-47
- Acronym
- NEURO-ACL-ISOE
- Status last verified
- Sep 2026
- First submitted
- 21 Aug 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Neuromuscular Profiles After Anterior Cruciate Ligament Reconstruction in Clinical Conditions: Combined Analysis of Isokinetic Strength and Surface Electromyography
- ClinicalTrials.gov ID
- NCT07792863
- Acronym / sponsor ID
- NEURO-ACL-ISOE / NEURO-ACL-ISOEMG
- Conditions
- Anterior Cruciate Ligament Injury
- Keywords
- Anterior Cruciate Ligament Reconstruction, Neuromuscular Recovery, Isokinetic Strength, Surface Electromyography, Quadriceps, Hamstrings, Muscle Activation, Functional Assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hopitaux de Saint-MauriceUniversity, hospital or other
- Study start
- 21 Aug 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients After ACL Reconstruction | – | Other: Neuromuscular and Patient-Reported AssessmenAdults evaluated between 4 and 12 months after anterior cruciate ligament (ACL) reconstruction as part of their routine functional assessment. Participants undergo isokinetic strength assessment and a single-leg hop test as part of routine care, complemented for the study by surface electromyography and patient-reported questionnaires assessing knee self-efficacy, kinesiophobia, symptoms, and knee function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (5 listed)
- 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.
- Ability to understand the study information and to express non-opposition to participation.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular and Patient-Reported AssessmenSurface 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. | Other | Patients After ACL Reconstruction |
Primary outcome
Distribution of Neuromuscular Profiles
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.
4 secondary outcomes
Surface Electromyographic Activity During the Single Leg Hop for Distance
Time frame: During the single study visit, between 4 and 12 months after ACL reconstruction
Distribution of Participants Across Neuromuscular Profile
Time frame: During the single study visit, between 4 and 12 months after ACL reconstruction
Correlation Between Neuromuscular Parameters and Functional and Patient-Reported Outcomes
Time frame: During the single study visit, between 4 and 12 months after ACL reconstruction
Completeness of Neuromuscular and Functional Assessment Data
Time frame: During the single study visit, between 4 and 12 months after ACL reconstruction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sylvain BS BELOT, md principal investigator
Hopitaux Paris Est Val-de-Marne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Injury, run by Hopitaux de Saint-Maurice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvain SB BELOT, MD (+33143966383, sylvain.belot@hpevm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of Neuromuscular Profiles (time frame: During the single study visit, between 4 and 12 months after ACL reconstruction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.