Early Treatment Based Neuroscience Education in Knee

NCT05440890 | Completed DMC

• 1 other identifier: UMAESHPhD
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Injuries

Keywords

cross-education; physiotherapy; unilateral strength training; fMRI; anterior cruciate ligament

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Pre-surgery and 12 week post-surgery

Secondary Outcomes (10)

• Limb symmetry index (LSI).

  Pre- surgery, 12 week post-surgery

• Peak rate of force development (RFD).

  Pre- surgery, 12 week post-surgery

• Muscle activation

  Pre- surgery, 6 week post-surgery, 12 week post-surgery

• Cross-sectional area of quadriceps

  Pre- surgery, 12 week post-surgery

• The International Knee Documentation Committee (IKDC) questionnarie.

  Pre- surgery12 weeks post-surgery

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

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.

Other: Best current rehabilitation protocol; Other: Cross-training protocol

Interventions

Best current rehabilitation protocol OTHER

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.

Control group; Cross-education group

Cross-training protocol OTHER

Beginning on 2º week after ACLR, 2 times per week during 10 weeks, based on isotonic exercise in leg extension and leg press.

Cross-education group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Diagnosis of systematic disease, no injury or symptomatic in contralateral lower limb, pregnancy, current or prior neurologic condiction.

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

Antonio Cuesta Vargas

Málaga, Spain

Location

Related Publications (2)

• 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.

  PMID: 33175329 BACKGROUND

• 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.

  PMID: 35279020 RESULT

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors are not aware of the allocation group of the participants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Research

Model Details: Randomized controlled trial, with two parallel groups (control and intervention)

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 1, 2022
• Study Start: April 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: February 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

ES (1)