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
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
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
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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