MedDataX Logo

Early Treatment Based Neuroscience Education in Knee

NCT ID: NCT05440890

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Injuries

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

cross-education physiotherapy unilateral strength training fMRI anterior cruciate ligament

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial, with two parallel groups (control and intervention)
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Assessors are not aware of the allocation group of the participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

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

Group Type ACTIVE_COMPARATOR

Best current rehabilitation protocol

Intervention Type 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.

Cross-education group

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.

Group Type EXPERIMENTAL

Best current rehabilitation protocol

Intervention Type 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.

Cross-training protocol

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Malaga

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Antonio I Cuesta-Vargas

Director, Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 33175329 (View on PubMed)

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.

Reference Type RESULT
PMID: 35279020 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UMAESHPhD

Identifier Type: -

Identifier Source: org_study_id