Clinical trial NCT05487768: Functional Connectivity After Anterior Cruciate Ligament Reconstruction
Official title: Functional Connectivity After Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Electroencephalography
Injuries
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2022-08-04
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Change in functional connectivity in the brain in patients following anterior cruciate ligament reconstruction
timeFrame: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
Secondary outcomes:
measure: Change in subjective knee functionality measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) - Questionnaire
timeFrame: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
measure: Change in kinesiophobia measured by the Tampa scale of Kinesiophobia (TSK) - Questionnaire
timeFrame: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
measure: Change in knee confidence - Questionnaire
timeFrame: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
measure: Change in worrying behaviour measured by the Penn State Worry Questionnaire (PSWQ) - Questionnaire
timeFrame: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
measure: Change in athletes' emotion, confidence, and risk appraisal when returning to sports after an anterior cruciate ligament reconstruction measured by the ACL-Return to sport after injury (ACL-RSI) - Questionnaire
timeFrame: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
measure: Follow up questionnaire
timeFrame: Monthly, for one year after the end of the rehabilitation (on average 9-12 months postoperative).
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University, Department of Rehabilitation Sciences
Study officials:
affiliation: Department of Rehabilitation Sciences, Ghent University
name: Erik Witvrouw, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: