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Early Treatment Based Neuroscience Education in Knee (ETbNE)

Primary Purpose

Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Injuries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Best current rehabilitation protocol
Cross-training protocol
Sponsored by
University of Malaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Rupture focused on measuring cross-education, physiotherapy, unilateral strength training, fMRI, anterior cruciate ligament

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control group

    Cross-education group

    Arm Description

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

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Limb symmetry index (LSI).
    Comparison of both quadriceps MVC. Measured in percentage.
    Peak rate of force development (RFD).
    Explosive strength as the speed which the muscle (quadriceps) can develop force. Measured in newtons per second.
    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.
    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.
    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.
    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.
    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.
    Muscle thickness of quadriceps.
    Measured in cm by ultrasonography in both quadriceps.
    Step length during gait
    Measured in cm of each limb with Optogait system.
    Contact time with the ground during gait
    Measured in seconds of each limb with Optogait system
    Cadence of the gait
    Measured in step per seconds with Optogait system

    Full Information

    First Posted
    June 21, 2022
    Last Updated
    June 27, 2022
    Sponsor
    University of Malaga
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05440890
    Brief Title
    Early Treatment Based Neuroscience Education in Knee
    Acronym
    ETbNE
    Official Title
    Early Treatment Based Neuroscience Education in Anterior Cruciate Ligament Repair Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    October 1, 2022 (Anticipated)
    Study Completion Date
    September 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Malaga

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Injuries
    Keywords
    cross-education, physiotherapy, unilateral strength training, fMRI, anterior cruciate ligament

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized controlled trial, with two parallel groups (control and intervention)
    Masking
    Outcomes Assessor
    Masking Description
    Assessors are not aware of the allocation group of the participants
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Standard protocol rehabilitation programme for an anterior cruciate ligament repair based on VAN MELICK N, et al 2016.
    Arm Title
    Cross-education group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Best current rehabilitation protocol
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Cross-training protocol
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Changes in quadriceps strength.
    Description
    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.
    Time Frame
    Baseline and 12 weeks post-surgery
    Title
    Changes in cortical adaptation.
    Description
    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.
    Time Frame
    Baseline and 10 weeks post-surgery
    Secondary Outcome Measure Information:
    Title
    Limb symmetry index (LSI).
    Description
    Comparison of both quadriceps MVC. Measured in percentage.
    Time Frame
    Pre- surgery, 12 weeks post-surgery
    Title
    Peak rate of force development (RFD).
    Description
    Explosive strength as the speed which the muscle (quadriceps) can develop force. Measured in newtons per second.
    Time Frame
    Pre- surgery, 12 weeks post-surgery
    Title
    Muscle activation.
    Description
    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.
    Time Frame
    Pre- surgery, 12 weeks post-surgery
    Title
    Cross-sectional area of quadriceps
    Description
    Sonography of quadriceps to determine the cross-sectional area of rectus femoris, vastus medialis and vastus laterlis. Measured in cm2.
    Time Frame
    Pre- surgery, 12 weeks post-surgery
    Title
    The International Knee Documentation Committee (IKDC) questionnarie.
    Description
    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.
    Time Frame
    12 weeks post-surgery
    Title
    The Lysholm questionnaire.
    Description
    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.
    Time Frame
    12 weeks post-surgery
    Title
    The Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire.
    Description
    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.
    Time Frame
    12 weeks post-surgery
    Title
    Muscle thickness of quadriceps.
    Description
    Measured in cm by ultrasonography in both quadriceps.
    Time Frame
    Pre- surgery, 12 weeks post-surgery
    Title
    Step length during gait
    Description
    Measured in cm of each limb with Optogait system.
    Time Frame
    12 weeks post-surgery
    Title
    Contact time with the ground during gait
    Description
    Measured in seconds of each limb with Optogait system
    Time Frame
    12 weeks post-surgery
    Title
    Cadence of the gait
    Description
    Measured in step per seconds with Optogait system
    Time Frame
    12 weeks post-surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33175329
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    35279020
    Citation
    Cuyul-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.
    Results Reference
    result

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    Early Treatment Based Neuroscience Education in Knee

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