NCT07792863

Brief 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. 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 Health

63
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Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
4mo left

Started Sep 2026

Shorter than P25 for all trials

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

August 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

August 21, 2026

Last Update Submit

August 25, 2026

Conditions

Keywords

Anterior Cruciate Ligament ReconstructionNeuromuscular RecoveryIsokinetic StrengthSurface ElectromyographyQuadricepsHamstringsMuscle ActivationFunctional Assessment

Outcome Measures

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.

    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

    During the single study visit, between 4 and 12 months after ACL reconstruction

  • Distribution of Participants Across Neuromuscular Profile

    During the single study visit, between 4 and 12 months after ACL reconstruction

  • Correlation Between Neuromuscular Parameters and Functional and Patient-Reported Outcomes

    During the single study visit, between 4 and 12 months after ACL reconstruction

  • Completeness of Neuromuscular and Functional Assessment Data

    During the single study visit, between 4 and 12 months after ACL reconstruction

Study Arms (1)

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.

Other: Neuromuscular and Patient-Reported Assessmen

Interventions

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.

Patients After ACL Reconstruction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Paris Est Val-de-Marne - Service de rééducation orthopédique et traumatologie

Saint-Maurice, Demande, 94410, France

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Sylvain BS BELOT, md

    Hopitaux Paris Est Val-de-Marne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvain SB BELOT, MD

CONTACT

Auriane AS SLAMA

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2026

First Posted

August 28, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 28, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations