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Functional Connectivity After Anterior Cruciate Ligament Reconstruction (FCACLR)

G

Ghent University Hospital (UZ)

Status

Completed

Conditions

Injuries
Electroencephalography
Anterior Cruciate Ligament Rupture

Treatments

Other: EEG measurement

Study type

Interventional

Funder types

Other

Identifiers

NCT05487768
ONZ-2022-0231

Details and patient eligibility

About

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.

Enrollment

78 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

PATIENT GROUP

Inclusion Criteria:

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

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

Inclusion Criteria:

  • 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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

78 participants in 2 patient groups

Anterior cruciate ligament reconstruction group
Experimental group
Description:
Patients that underwent an anterior cruciate ligament reconstruction
Treatment:
Other: EEG measurement
Control group
Active Comparator group
Description:
Healthy matched controls
Treatment:
Other: EEG measurement

Trial contacts and locations

1

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Central trial contact

Sander Denolf, Msc.

Data sourced from clinicaltrials.gov

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