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Completed

NCT Number: NCT05487768

Functional Connectivity After Anterior Cruciate Ligament Reconstruction

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.

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Key information

Conditions

Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Injuries Electroencephalography Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University, Department of Rehabilitation Sciences

Ghent, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EEG measurement

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)

Primary outcomes

  1. Change in functional connectivity in the brain in patients following anterior cruciate ligament reconstruction

    Time frame: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline

    Electroencephalography (EEG) will be recorded from a 128 Sn surface electrode cap during 3 motor tasks. Functional connectivity will be analyzed.

Secondary outcomes

  1. Change in subjective knee functionality measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) - Questionnaire

    Time frame: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline

    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.

  2. Change in kinesiophobia measured by the Tampa scale of Kinesiophobia (TSK) - Questionnaire

    Time frame: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline

    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.

  3. Change in knee confidence - Questionnaire

    Time frame: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline

    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.

  4. Change in worrying behaviour measured by the Penn State Worry Questionnaire (PSWQ) - Questionnaire

    Time frame: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline

    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.

  5. 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

    Time frame: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline

    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.

  6. Follow up questionnaire

    Time frame: Monthly, 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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • University Ghent

Registry information

Acronym: FCACLR

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 4, 2022
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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