Functional Connectivity After Anterior Cruciate Ligament Reconstruction (FCACLR)

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.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Rupture; Injuries; Electroencephalography
• Intervention / Treatment: Other: EEG measurement

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium
    • Ghent University, Department of Rehabilitation Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anterior cruciate ligament reconstruction group; Patients that underwent an anterior cruciate ligament reconstruction	Other: 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)
Active Comparator: Control group; Healthy matched controls	Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in functional connectivity in the brain in patients following anterior cruciate ligament reconstruction	Electroencephalography (EEG) will be recorded from a 128 Sn surface electrode cap during 3 motor tasks. Functional connectivity will be analyzed.	Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in subjective knee functionality measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) - Questionnaire	Assess 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.	Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
Change in kinesiophobia measured by the Tampa scale of Kinesiophobia (TSK) - Questionnaire	This 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.	Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
Change in knee confidence - Questionnaire	To 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.	Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
Change in worrying behaviour measured by the Penn State Worry Questionnaire (PSWQ) - Questionnaire	This 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.	Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
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	This 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.	Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
Follow up questionnaire	To monitor return to sport and injury occurence in the patient group	Monthly, for one year after the end of the rehabilitation (on average 9-12 months postoperative).

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: University Ghent
• Investigators: Principal Investigator: Erik Witvrouw, Prof. Dr., Department of rehabilitation sciences, Ghent university

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2022
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 4, 2022

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: ONZ-2022-0231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No