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Early Treatment Based Neuroscience Education in Knee

Early Treatment Based Neuroscience Education in Anterior Cruciate Ligament Repair Patients

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05440890
Acronym
ETbNE
Enrollment
29
Registered
2022-07-01
Start date
2025-04-01
Completion date
2026-02-01
Last updated
2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture

Keywords

cross-education, physiotherapy, unilateral strength training, fMRI, anterior cruciate ligament

Brief summary

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

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.

Interventions

OTHERBest 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.

OTHERCross-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.

Sponsors

University of Malaga
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Assessors are not aware of the allocation group of the participants

Intervention model description

Randomized controlled trial, with two parallel groups (control and intervention)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in quadriceps strength.Pre-surgery and 12 week post-surgeryIsometric 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.
Structural changes in brain.Pre-surgery and 12 week post-surgeryFractional 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.
Functional changes in brainPre-surgery and 12 week post-surgeryFunctional 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

MeasureTime frameDescription
Limb symmetry index (LSI).Pre- surgery, 12 week post-surgeryComparison of both quadriceps MVC. Measured in percentage.
Peak rate of force development (RFD).Pre- surgery, 12 week post-surgeryExplosive strength as the speed which the muscle (quadriceps) can develop force. Measured in newtons per second.
Muscle activationPre- surgery, 6 week post-surgery, 12 week post-surgerySurface 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.
Cross-sectional area of quadricepsPre- surgery, 12 week post-surgerySonography of quadriceps to determine the cross-sectional area of rectus femoris, vastus medialis and vastus laterlis. Measured in cm2.
The International Knee Documentation Committee (IKDC) questionnarie.Pre- surgery12 weeks post-surgeryIKDC 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.
The Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire.Pre-surgery, 2 week, 4 week, 6 week, 8 week, 10 week and 12 week post-surgeryThe 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.
Muscle thickness of quadriceps.Pre- surgery, 12 week post-surgeryMeasured in cm by ultrasonography in both quadriceps.
Single leg standPre-surgery, 6 week and 12 week post-surgeryChanges 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.
Double leg squat assessmentPre-surgery, 6 week and 12 week post-surgeryPatients 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.
The TSK-11 questionnairePre- surgery, 12 week post-surgeryThe 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026