Early Treatment Based Neuroscience Education in Knee

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

Detailed Description
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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 8 weeks to check the possible benefits of the transfer in a sample of ACL repair.

Official Title
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Early Treatment Based Neuroscience Education in Anterior Cruciate Ligament Repair Patients

Conditions
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Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Injuries

Intervention / Treatment
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* Other: Best current rehabilitation protocol
* Other: Cross-training protocol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial, with two parallel groups (control and intervention)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Standard protocol rehabilitation programme for an anterior cruciate ligament repair based on VAN MELICK N, et al 2016. | Other: Best current rehabilitation protocol<br>* 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.<br>|
| Experimental: Cross-education group<br>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<br>* 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.<br>Other: Cross-training protocol<br>* Beginning on 2º week after ACLR, 3 times per week during 8 weeks, based on isotonic exercise at least to 80% of 1RM in leg extension. 5 sets o 6 repetions with 1,5 - 2 minutes between series.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in quadriceps strength. | Isometric Maximal voluntary contraction in 60º/90º of knee flexion. 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. | Baseline and 12 weeks post-surgery | 
| Changes in cortical adaptation. | Functional magnetic resonance including tractography, blood oxygen level dependent (BOLD) and resting-state study to measure how and where the cortical activation is meanwhile the subjects perform a 50% of the MVIC of knee extension with the injuried leg. Special focus on primery motor cortex and supplementary motor area. | Baseline and 10 weeks post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limb symmetry index (LSI). | Comparison of both quadriceps MVC. Measured in percentage. | Pre- surgery, 12 weeks 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. | Pre- surgery, 12 weeks post-surgery | 
| Muscle activation. | Surface eletromyography in the main muscles of lower limb (rectus femoris, vastus medialis, vasto lateralis, biceps femoris) during the MVC test and functional task such as active straigth leg raise, gait, bilateral/unilateral squat, bilateral/unilateral rumanian deadlift, lunges and single and normal countermovement jump. | Pre- surgery, 12 weeks 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. | Pre- surgery, 12 weeks 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. | 12 weeks post-surgery | 
| The Lysholm questionnaire. | Total score of 100 points including the following variables: crutch support, knee locking, knee instability, pain, swelling and knee function. Score range 0 to 100 with high scores indicating better and positive knee outcomes. | 12 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. | 12 weeks post-surgery | 
| Muscle thickness of quadriceps. | Measured in cm by ultrasonography in both quadriceps. | Pre- surgery, 12 weeks post-surgery | 
| Step length during gait | Measured in cm of each limb with Optogait system. | 12 weeks post-surgery | 
| Contact time with the ground during gait | Measured in seconds of each limb with Optogait system | 12 weeks post-surgery | 
| Cadence of the gait | Measured in step per seconds with Optogait system | 12 weeks post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cross-education, physiotherapy, unilateral strength training, fMRI, anterior cruciate ligament