Anterior Cruciate Ligament RuptureETbNENCT05440890
Early Treatment Based Neuroscience Education in Knee
A study testing Best current rehabilitation protocol and Cross-training protocol in people with Anterior Cruciate Ligament Rupture and Anterior Cruciate Ligament Injuries, run by University of Malaga at 1 site in Spain.
Trial summary
Determine the effecttiveness of a cross-education strength training protocol in a group of subjects with an anterior cruciate ligament surgery. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Injuries
- What is being tested?
- Best current rehabilitation protocol and Cross-training protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Diagnosis of systematic disease, no injury or symptomatic in contralateral lower limb, pregnancy, current or prior neurologic condiction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Best current rehabilitation protocol, Cross-training protocol
- Keywords
- cross-education, physiotherapy, unilateral strength training, fMRI, anterior cruciate ligament
- 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.
Best current rehabilitation protocolOther
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 protocolOther
Beginning on 2º week after ACLR, 2 times per week during 10 weeks, based on isotonic exercise in leg extension and leg press.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Standard protocol rehabilitation programme for an anterior cruciate ligament repair based on VAN MELICK N, et al 2016. Receives: Other: Best current rehabilitation protocol |
| Cross-education group | Experimental | 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. Receives: Other: Best current rehabilitation protocol; Other: Cross-training protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in quadriceps strength.
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.
Measured: Pre-surgery and 12 week post-surgery
Structural changes in brain.
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.
Measured: Pre-surgery and 12 week post-surgery
Functional changes in brain
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.
Measured: Pre-surgery and 12 week post-surgery
Secondary outcomes (10)
Limb symmetry index (LSI).
Comparison of both quadriceps MVC. Measured in percentage.
Measured: Pre- surgery, 12 week post-surgery
Peak rate of force development (RFD).
Explosive strength as the speed which the muscle (quadriceps) can develop force. Measured in newtons per second.
Measured: Pre- surgery, 12 week post-surgery
Muscle activation
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.
Measured: Pre- surgery, 6 week post-surgery, 12 week post-surgery
Cross-sectional area of quadriceps
Sonography of quadriceps to determine the cross-sectional area of rectus femoris, vastus medialis and vastus laterlis. Measured in cm2.
Measured: Pre- surgery, 12 week post-surgery
The International Knee Documentation Committee (IKDC) questionnarie.
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.
Measured: Pre- surgery12 weeks post-surgery
The Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire.
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.
Measured: Pre-surgery, 2 week, 4 week, 6 week, 8 week, 10 week and 12 week post-surgery
Muscle thickness of quadriceps.
Measured in cm by ultrasonography in both quadriceps.
Measured: Pre- surgery, 12 week post-surgery
Single leg stand
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.
Measured: Pre-surgery, 6 week and 12 week post-surgery
Double leg squat assessment
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.
Measured: Pre-surgery, 6 week and 12 week post-surgery
The TSK-11 questionnaire
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.
Measured: Pre- surgery, 12 week post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start1 Apr 2025
- Primary completion1 May 2025
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament RuptureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial, with two parallel groups (control and intervention)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Antonio I Cuesta-Vargas, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440890
- Sponsor's protocol ID
- UMAESHPhD
- Acronym
- ETbNE
- Status last verified
- Apr 2026
- First submitted
- 21 Jun 2022
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Manca A, Hortobagyi T, Carroll TJ, Enoka RM, Farthing JP, Gandevia SC, Kidgell DJ, Taylor JL, Deriu F. Contralateral Effects of Unilateral Strength and Skill Training: Modified Delphi Consensus to Establish Key Aspects of Cross-Education. Sports Med. 2021 Jan;51(1):11-20. doi: 10.1007/s40279-020-01377-7.
PubMed 33175329Cuyul-Vasquez I, Alvarez E, Riquelme A, Zimmermann R, Araya-Quintanilla F. Effectiveness of Unilateral Training of the Uninjured Limb on Muscle Strength and Knee Function of Patients With Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-Analysis of Cross-Education. J Sport Rehabil. 2022 Mar 12;31(5):605-616. doi: 10.1123/jsr.2021-0204. Print 2022 Jul 1.
PubMed 35279020
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Treatment Based Neuroscience Education in Anterior Cruciate Ligament Repair Patients
- ClinicalTrials.gov ID
- NCT05440890
- Acronym / sponsor ID
- ETbNE / UMAESHPhD
- Keywords
- cross-education, physiotherapy, unilateral strength training, fMRI, anterior cruciate ligament
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 1 Jul 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial, with two parallel groups (control and intervention)
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Best current rehabilitation protocolStandard protocol rehabilitation programme for an anterior cruciate ligament repair based on VAN MELICK N, et al 2016. |
| Cross-education group | Experimental | Other: Best current rehabilitation protocol, Other: Cross-training protocolStandard protocol rehabilitation programme for an anterior cruciate ligament repair based on VAN MELICK N, et al 2016. Additionally a contralateral lower limb strength training. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Diagnosis of systematic disease, no injury or symptomatic in contralateral lower limb, pregnancy, current or prior neurologic condiction.
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 |
|---|---|---|
| Best current rehabilitation protocolInflamation 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 | Control group, Cross-education group |
| Cross-training protocolBeginning on 2º week after ACLR, 2 times per week during 10 weeks, based on isotonic exercise in leg extension and leg press. | Other | Cross-education group |
Primary outcome
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.
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.
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.
10 secondary outcomes
Limb symmetry index (LSI).
Time frame: Pre- surgery, 12 week post-surgery
Peak rate of force development (RFD).
Time frame: Pre- surgery, 12 week post-surgery
Muscle activation
Time frame: Pre- surgery, 6 week post-surgery, 12 week post-surgery
Cross-sectional area of quadriceps
Time frame: Pre- surgery, 12 week post-surgery
The International Knee Documentation Committee (IKDC) questionnarie.
Time frame: 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
Muscle thickness of quadriceps.
Time frame: Pre- surgery, 12 week post-surgery
Single leg stand
Time frame: Pre-surgery, 6 week and 12 week post-surgery
Double leg squat assessment
Time frame: Pre-surgery, 6 week and 12 week post-surgery
The TSK-11 questionnaire
Time frame: Pre- surgery, 12 week post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 33175329Manca A, Hortobagyi T, Carroll TJ, Enoka RM, Farthing JP, Gandevia SC, Kidgell DJ, Taylor JL, Deriu F. Contralateral Effects of Unilateral Strength and Skill Training: Modified Delphi Consensus to Establish Key Aspects of Cross-Education. Sports Med. 2021 Jan;51(1):11-20. doi: 10.1007/s40279-020-01377-7.
- Results publication: PubMed 35279020Cuyul-Vasquez I, Alvarez E, Riquelme A, Zimmermann R, Araya-Quintanilla F. Effectiveness of Unilateral Training of the Uninjured Limb on Muscle Strength and Knee Function of Patients With Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-Analysis of Cross-Education. J Sport Rehabil. 2022 Mar 12;31(5):605-616. doi: 10.1123/jsr.2021-0204. Print 2022 Jul 1.
Related trials for Anterior Cruciate Ligament Rupture
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best current rehabilitation protocol and Cross-training protocol in people with Anterior Cruciate Ligament Rupture and Anterior Cruciate Ligament Injuries, run by University of Malaga at 1 site in Spain.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 8 Apr 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in quadriceps strength. (time frame: Pre-surgery and 12 week post-surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05440890, which also lists 2 linked publications.
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 8 Apr 2026.