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Completed

NCT Number: NCT05440890

Early Treatment Based Neuroscience Education in Knee

Determine the effecttiveness of a cross-education strength training protocol in a group of subjects with an anterior cruciate ligament surgery.

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Key information

Conditions

Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antonio Cuesta Vargas

Málaga, Spain

About this study

The cross-education (CE) phenomenon has been studied in recent years as a form of gain muscle strength not only in healthy subjects but also in acute injuries such as musculoskeletal disorders and immovilitations. Unilateral training of the not injured limb has been suggested as an option to produce cross-edutation in terms of strength and skills. In addition, functional magnetic resonance imaging have been postulated as a promising tool to study the mechanisms of transfer.

In the context of our study, arthrogenic muscle inhibition (AMI) of knee extensors is a common consequence after ACL repair in which a CE strength training can lead to reduce quadriceps atrophy and its implications in long terms achievements. Thus, an unilateral strength protocol of the uninjuried limb, according to the last Delphi Consensus, will be run for 10 weeks to check the possible benefits of the transfer in a sample of ACL repair.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • People between 18 and 40 years whith MRI diagnosis of ACL rupture.
  • Autograft, allograft or artificail graft of any source.
  • With/without any meniscal resection/repair.

Exclusion criteria

  • Diagnosis of systematic disease, no injury or symptomatic in contralateral lower limb, pregnancy, current or prior neurologic condiction.

Treatment and study plan

Best current rehabilitation protocol

Other

Inflamation control and edema with physical agents, recover full pasive and active range of motion, normalize gait pattern, lower limb strengthening (specially quadriceps and hamstrings), neuromuscular control training, cycling, landings and running.

Cross-training protocol

Other

Beginning on 2º week after ACLR, 2 times per week during 10 weeks, based on isotonic exercise in leg extension and leg press.

Primary outcomes

  1. Changes in quadriceps strength.

    Time frame: Pre-surgery and 12 week post-surgery

    Isometric Maximal voluntary contraction in 60º/90º of knee extension. Both legs. Patients performed two familiarization trials at 50% of their estimated MVC. Then 3 test of maximal contraction will be done. Measured in newtons.

  2. Structural changes in brain.

    Time frame: Pre-surgery and 12 week post-surgery

    Fractional anisotropy (FA) and mean diffusivity (MD) will be used for measure white matter microstructure and corticospinal tracts with diffusion tensor imaging (DTI). Voxel-based morphometry (VBM) will be used to measure volumen, thickness and size of white matter in with T1-weighted images.

  3. Functional changes in brain

    Time frame: Pre-surgery and 12 week post-surgery

    Functional magnetic resonance imaging (fMRI) with active and resting blocks of knee extensions in both legs, and resting-state imaging. Blood-oxygen level dependent (BOLD) will be used for measure functional connectivity in resting and during motor task.

Secondary outcomes

  1. Limb symmetry index (LSI).

    Time frame: Pre- surgery, 12 week post-surgery

    Comparison of both quadriceps MVC. Measured in percentage.

  2. Peak rate of force development (RFD).

    Time frame: Pre- surgery, 12 week post-surgery

    Explosive strength as the speed which the muscle (quadriceps) can develop force. Measured in newtons per second.

  3. Muscle activation

    Time frame: Pre- surgery, 6 week post-surgery, 12 week post-surgery

    Surface eletromyography in the main muscles of quadriceps (rectus femoris, vastus medialis, vasto lateralis) during the MVIC test and double leg squat. Peaks in root-mean-square value (RMS) will be taken for each muscle in each test.

  4. Cross-sectional area of quadriceps

    Time frame: Pre- surgery, 12 week post-surgery

    Sonography of quadriceps to determine the cross-sectional area of rectus femoris, vastus medialis and vastus laterlis. Measured in cm2.

  5. The International Knee Documentation Committee (IKDC) questionnarie.

    Time frame: Pre- surgery12 weeks post-surgery

    IKDC is a reliable and valid measure for ACLR. It consists on 10 items related to knee symptons, knee function and sports activities. Score range from 0 to 100 with higher scores determine less disfunction.

  6. The Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire.

    Time frame: Pre-surgery, 2 week, 4 week, 6 week, 8 week, 10 week and 12 week post-surgery

    The KOOS is a self-administered questionnaire with variables related to symptons, pain, quality of life, daily tasks and function and sport activities. Score range 0 to 100 with high scores indicating better and positive knee outcomes.

  7. Muscle thickness of quadriceps.

    Time frame: Pre- surgery, 12 week post-surgery

    Measured in cm by ultrasonography in both quadriceps.

  8. Single leg stand

    Time frame: Pre-surgery, 6 week and 12 week post-surgery

    Changes in medial-lateral and anterior-posterior center of pressure (mm) and mean velocity changes (mm/s) will be analyzed during single leg stand in both legs with force platforms.

  9. Double leg squat assessment

    Time frame: Pre-surgery, 6 week and 12 week post-surgery

    Patients will be asked to perform squat in two ways: as deep as the can and also limited to 90º of knee flexion. 3 set of 5 repetitions. Assymmetry in concenctric and eccentric mean force (%) between left and right limb and maximum negative displacement (cm) will be used to measure differences in each limb performance.

  10. The TSK-11 questionnaire

    Time frame: Pre- surgery, 12 week post-surgery

    The Tampa Scale for Kinesiophobia is a self-administered questionnaire to evaluate fear to movement, pain and re-injury. Score range 0 to 11, indicating better results with higher score.

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Registry information

Official study title

Early Treatment Based Neuroscience Education in Anterior Cruciate Ligament Repair Patients

Acronym: ETbNE

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 1, 2022
Registry last updated
Apr 8, 2026

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.

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