Early Treatment Based Neuroscience Education in Knee (ETbNE)

April 2, 2026 updated by: Dr. Antonio I Cuesta-Vargas, University of Malaga

Early Treatment Based Neuroscience Education in Anterior Cruciate Ligament Repair Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Málaga, Spain
        • Antonio Cuesta Vargas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Standard protocol rehabilitation programme for an anterior cruciate ligament repair based on VAN MELICK N, et al 2016.
Other: Best current rehabilitation protocol
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.
Experimental: Cross-education group

Standard protocol rehabilitation programme for an anterior cruciate ligament repair based on VAN MELICK N, et al 2016.

Additionally a contralateral lower limb strength training.
Other: Best current rehabilitation protocol
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.
Other: Cross-training protocol
Beginning on 2º week after ACLR, 2 times per week during 10 weeks, based on isotonic exercise in leg extension and leg press.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-surgery and 12 week post-surgery
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.
Pre-surgery and 12 week post-surgery
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.
Pre-surgery and 12 week post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Limb symmetry index (LSI).
Time Frame: Pre- surgery, 12 week post-surgery
Comparison of both quadriceps MVC. Measured in percentage.
Pre- surgery, 12 week post-surgery
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.
Pre- surgery, 12 week post-surgery
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.
Pre- surgery, 6 week post-surgery, 12 week post-surgery
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.
Pre- surgery, 12 week post-surgery
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.
Pre- surgery12 weeks post-surgery
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.
Pre-surgery, 2 week, 4 week, 6 week, 8 week, 10 week and 12 week post-surgery
Muscle thickness of quadriceps.
Time Frame: Pre- surgery, 12 week post-surgery
Measured in cm by ultrasonography in both quadriceps.
Pre- surgery, 12 week post-surgery
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.
Pre-surgery, 6 week and 12 week post-surgery
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.
Pre-surgery, 6 week and 12 week post-surgery
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.
Pre- surgery, 12 week post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaga

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Actual)

May 1, 2025

Study Completion (Actual)

February 1, 2026

Study Registration Dates

First Submitted

June 21, 2022

First Submitted That Met QC Criteria

June 27, 2022

First Posted (Actual)

July 1, 2022

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMAESHPhD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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