Functional Connectivity After Anterior Cruciate Ligament Reconstruction (FCACLR)
Primary Purpose
Anterior Cruciate Ligament Rupture, Electroencephalography, Injuries
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
EEG measurement
Sponsored by
About this trial
This is an interventional prevention trial for Anterior Cruciate Ligament Rupture
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.
Sites / Locations
- Ghent University, Department of Rehabilitation SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Anterior cruciate ligament reconstruction group
Control group
Arm Description
Patients that underwent an anterior cruciate ligament reconstruction
Healthy matched controls
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Follow up questionnaire
To monitor return to sport and injury occurence in the patient group
Full Information
NCT ID
NCT05487768
First Posted
July 27, 2022
Last Updated
January 3, 2023
Sponsor
University Hospital, Ghent
Collaborators
University Ghent
1. Study Identification
Unique Protocol Identification Number
NCT05487768
Brief Title
Functional Connectivity After Anterior Cruciate Ligament Reconstruction
Acronym
FCACLR
Official Title
Functional Connectivity After Anterior Cruciate Ligament Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 23, 2022 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
University Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture, Electroencephalography, Injuries
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anterior cruciate ligament reconstruction group
Arm Type
Experimental
Arm Description
Patients that underwent an anterior cruciate ligament reconstruction
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Healthy matched controls
Intervention Type
Other
Intervention Name(s)
EEG measurement
Intervention Description
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 Outcome Measure Information:
Title
Change in functional connectivity in the brain in patients following anterior cruciate ligament reconstruction
Description
Electroencephalography (EEG) will be recorded from a 128 Sn surface electrode cap during 3 motor tasks. Functional connectivity will be analyzed.
Time Frame
Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
Secondary Outcome Measure Information:
Title
Change in subjective knee functionality measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) - Questionnaire
Description
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.
Time Frame
Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
Title
Change in kinesiophobia measured by the Tampa scale of Kinesiophobia (TSK) - Questionnaire
Description
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.
Time Frame
Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
Title
Change in knee confidence - Questionnaire
Description
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.
Time Frame
Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
Title
Change in worrying behaviour measured by the Penn State Worry Questionnaire (PSWQ) - Questionnaire
Description
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.
Time Frame
Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
Title
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
Description
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.
Time Frame
Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
Title
Follow up questionnaire
Description
To monitor return to sport and injury occurence in the patient group
Time Frame
Monthly, for one year after the end of the rehabilitation (on average 9-12 months postoperative).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sander Denolf, Msc.
Phone
+32 (0)9 332 69 17
Email
sander.denolf@ugent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Witvrouw, Prof. Dr.
Organizational Affiliation
Department of Rehabilitation Sciences, Ghent University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University, Department of Rehabilitation Sciences
City
Ghent
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sander Denolf, Msc
Phone
+32 (0)9 332 69 17
Email
sander.denolf@ugent.be
First Name & Middle Initial & Last Name & Degree
Evi Wezenbeek, Dr.
Phone
+32 (0)9 332 69 17
Email
evi.wezenbeek@ugent.be
12. IPD Sharing Statement
Learn more about this trial
Functional Connectivity After Anterior Cruciate Ligament Reconstruction
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