Early Treatment Based Neuroscience Education in Knee

Anterior Cruciate Ligament Injuries Clinical Trial

— ETbNE  

Official title:

Early Treatment Based Neuroscience Education in Anterior Cruciate Ligament Repair Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05440890
• Other study ID #: UMAESHPhD
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2025
• Est. completion date: September 1, 2025

Study information

• Verified date: June 2023
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: September 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Rupture
• Rupture

Intervention

Other:
• Best 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.
• Cross-training protocol
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaga

References & Publications (2)

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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Limb symmetry index (LSI).	Comparison of both quadriceps MVC. Measured in percentage.	Pre- surgery, 12 weeks post-surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Muscle thickness of quadriceps.	Measured in cm by ultrasonography in both quadriceps.	Pre- surgery, 12 weeks post-surgery
Secondary	Step length during gait	Measured in cm of each limb with Optogait system.	12 weeks post-surgery
Secondary	Contact time with the ground during gait	Measured in seconds of each limb with Optogait system	12 weeks post-surgery
Secondary	Cadence of the gait	Measured in step per seconds with Optogait system	12 weeks post-surgery