Functional Connectivity After Anterior Cruciate Ligament Reconstruction

NCT ID: NCT05487768

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-23
• Study Completion Date: 2024-07-31

Brief Summary

Background:

Despite surgical reconstruction and rehabilitation, individuals after a primary anterior cruciate ligament injury have a significantly increased risk of relapse. The mechanisms for this increased risk may go beyond mere physiological and biomechanical changes of the reconstructed anterior cruciate ligament. The loss of ligamentous mechanoreceptors can affect sensory feedback and consequently result in a disrupted afferent input to the central nervous system. However, research on the neuroplasticity of the central nervous system after anterior cruciate ligament injury and more specifically on the cooperation between different brain areas (=functional connectivity) in motor execution and performance is limited.

Research purpose:

To investigate the changes in terms of functional connectivity in the brain after sustaining an anterior cruciate ligament injury and associated reconstruction?

Population:

• Patients after anterior cruciate ligament reconstruction
• Healthy controls

Protocol:

First, all participants are required to complete several questionnaires regarding the level of anxiety and the functioning of the knee in daily activities and sports. In addition, during the baseline testing, participants will be required to perform an experiment while electrical brain activity is recorded by means of an electroencephalography (EEG) measurement. During this experiment, the participants will have to successively perform the following exercises: 10x knee extension from sitting (left and right), 10x bipodal squat from standing, 5x 30 seconds unipodal standing (left and right).

The above protocol will be administered to the patient group for the first time 8 weeks after the anterior cruciate ligament reconstruction. When the patients do not need further rehabilitation, they will be invited a second time to execute the same protocol again. The control group will only have to carry out the above protocol once.

Finally, for one year after the last test, the patient group will be contacted monthly to monitor return to sport and the occurrence of injuries.

Conditions

Anterior Cruciate Ligament Rupture; Electroencephalography; Injuries

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Anterior cruciate ligament reconstruction group

Patients that underwent an anterior cruciate ligament reconstruction

Group Type: EXPERIMENTAL

EEG measurement

Intervention Type: OTHER

EEG measurement to evaluate functional connectivity in the brain during 3 motor tasks:

• Knee extension while sitting (10x left - right)
• Bipodal squatting (10x)
• Unipodal stance (5x30 seconds left-right)

Control group

Healthy matched controls

Group Type: ACTIVE_COMPARATOR

EEG measurement

Intervention Type: OTHER

EEG measurement to evaluate functional connectivity in the brain during 3 motor tasks:

• Knee extension while sitting (10x left - right)
• Bipodal squatting (10x)
• Unipodal stance (5x30 seconds left-right)

Interventions

EEG measurement

EEG measurement to evaluate functional connectivity in the brain during 3 motor tasks:

• Knee extension while sitting (10x left - right)
• Bipodal squatting (10x)
• Unipodal stance (5x30 seconds left-right)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Older than 18 years of age.
• Primary anterior cruciate ligament rupture and reconstruction

• Older than 18 years of age.

Exclusion Criteria

• Major knee surgery in the past.
• Diagnosed with any knee pathology at this moment.
• Have any muscle or nerve related conditions that affect the functioning of the lower limbs.

CONTROL GROUP

• Major knee surgery in the past.
• Diagnosed with any knee pathology at this moment.
• Have any muscle or nerve related conditions that affect the functioning of the lower limbs.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Ghent

OTHER

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erik Witvrouw, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Rehabilitation Sciences, Ghent University

Locations

Ghent University, Department of Rehabilitation Sciences

Ghent, , Belgium

Countries

Belgium

Other Identifiers

ONZ-2022-0231

Identifier Type: -

Identifier Source: org_study_id