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Functional Connectivity After Anterior Cruciate Ligament Reconstruction

Functional Connectivity After Anterior Cruciate Ligament Reconstruction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05487768
Acronym
FCACLR
Enrollment
78
Registered
2022-08-04
Start date
2022-09-23
Completion date
2024-07-31
Last updated
2024-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Rupture, Electroencephalography, Injuries

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.

Interventions

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)

Sponsors

University Ghent
CollaboratorOTHER
University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in functional connectivity in the brain in patients following anterior cruciate ligament reconstructionExperimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baselineElectroencephalography (EEG) will be recorded from a 128 Sn surface electrode cap during 3 motor tasks. Functional connectivity will be analyzed.

Secondary

MeasureTime frameDescription
Change in kinesiophobia measured by the Tampa scale of Kinesiophobia (TSK) - QuestionnaireExperimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baselineThis questionnaire consists of 17 questions and evaluates the extent to which patients experience kinesiophobia. Each item is given a score between 0 and 4. A higher score indicates more kinesiophobia.
Change in knee confidence - QuestionnaireExperimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baselineTo evaluate the confidence of patients in their operated knee, expressed as a percentage relative to the nonoperated side (0-100%). A lower score indicates less confidence.
Change in subjective knee functionality measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) - QuestionnaireExperimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baselineAssess the patients opinion about their knee and associated problems. Each item is given a score between 0 and 4, then the total score is converted to a scale of 0-100. A higher score indicates less disfunction.
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) - QuestionnaireExperimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baselineThis questionnaire consists of 12 questions divided into three main sections: athletes' emotion, confidence, and risk assessment when returning to sport after an ACL injury and/or reconstructive surgery. Each item is given a score between 0 and 100, after which the total score is converted to a scale of 0-100. A lower score indicates more concerns about return to sport.
Follow up questionnaireMonthly, for one year after the end of the rehabilitation (on average 9-12 months postoperative).To monitor return to sport and injury occurence in the patient group
Change in worrying behaviour measured by the Penn State Worry Questionnaire (PSWQ) - QuestionnaireExperimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baselineThis questionnaire consists of 16 questions and evaluates the extent to which patients are concerned Each item is given a score between 1 and 5. The total scores range from 16 to 80 with higher scores indicative of higher levels of trait worry.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026