- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03336060
Neurophysiologic Correlates of Movement Planning During Complex Jump Landing Tasks and the Role of Cognitive Function
Long-term Effects of ACL Reconstruction Surgery on Neurophysiologic Correlates of Movement Planning During Complex Jump Landing Tasks and the Role of Neuropsychological Performance Measures: An Explorative Cross-sectional Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Particularly, in the context of ball sports ruptures of the anterior cruciate ligament (ACL) are among the most frequent injuries. However, the ACL tear does not only result in a loss of mechanical stability in the knee joint: the tear of the ligament and the subsequent reconstructive surgery lead to a massive damage of so-called mechanoreceptors (proprioceptors). These small sensors provide the brain with precise information on the tension of the cruciate ligament and the position of the knee joint. Due to this feedback, it is possible for humans to adjust the activity of the stabilizing muscles to various situations in sports and daily life and to protect the knee from injuries. Thus, coordination deficits are common consequences after ACL-rupture and reconstruction due to the poorer sensory feedback.
New findings provide evidence that the injury-induced damage of the mechanoreceptors also causes persistent, neuronal reorganisations in the brain (injury induced neuroplasticity). These relate in particular to the motor cortex by which voluntary movements are controlled. According to the results of imaging (eg. functional magnetic resonance tomography; MRI) and electrophysiological studies (eg. Electroencephalography; EEG), these neurologic adaptation appear to persist far beyond the resumption of daily, sporting or competitive activities. Researchers suggest that these adaptations of the central nervous system might be the underlying cause of the frequently observed, persistent motor control and functional deficits (eg. muscle strength and muscle activation deficits), the relatively high re-injury, low return to sports rates and small proportions returning to their initial performance level after ACL tears and reconstruction. A pure restoration of the neuromuscular function without the elimination of the neuroplastic changes in the brain does therefore not appear sufficient.
In recent studies the effects of ACL trauma on brain activity have been investigated exclusively during unspecific, sport- and injury-unrelated tests (eg. simple flexion and extension movements and angular reproduction tasks of the knee). Often, injuries to the ACL occur under unpredictable conditions, especially in complex, dynamic movements such as changes of direction, jumps and landings. Here, the brain has to process information from the receptors of the ACL as quickly as possible to initiate an adequate motor response to protect the knee.
Against the background of the above described findings, this cross-sectional case-control study will firstly investigate the effects of completely healed ACL tears and reconstruction (side symmetry of neuromuscular performance measures above 85%) on movement planning related cortical activity (via Electroencephalography) measures during complex jump-landing tasks: The study participants perform counter-movement jumps (n=80; CMJ, flight time approximately 500 ms) followed by single leg landings. While under an anticipated condition (n=40), the individuals receive the visual information (presented on a screen) on which leg/ foot (left, right) they are required to land before self-initiated CMJs, the individuals will receive this information under the non-anticipated condition (n=40) only after take-off (approximately 400 ms before ground contact). The measurement of the landing stability is standardized by means of selected biomechanical parameters (capacitive force platform). Injury-relevant, cognitive characteristics (e.g., reaction, information processing speed and working memory) are detected by computer and paper-based clinical cognition tests.
The investigators hypothesize that the injury-related neurological adjustments in the motor cortex lead to a more intensive motor action planning before movement initiation (compensation of sensory deficits). The increased use of neuronal capacities for movement planning could subsequently lead to a slower or to unprecise motor responses to unforeseen/ non-anticipated events and subsequently cause greater landing instability, or increase the knee injury risk, respectively. It is also assumed that a lower cognitive information processing is associated with a more instable landing, or a higher risk of injury or higher injury incidence rate, respectively.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Winfried Banzer, Prof
- Phone Number: 06979824482
- Email: banzer@sport.uni-frankfurt.de
Study Contact Backup
- Name: Florian Giesche, M.Sc.
- Phone Number: 06979824482
- Email: Giesche@sport.uni-frankfurt.de
Study Locations
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Hessen
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Frankfurt am Main, Hessen, Germany, 60487
- Recruiting
- Goethe University Department of Sports Medicine
-
Contact:
- Winfried Banzer, Prof
- Phone Number: 06979824482
- Email: banzer@sport.uni-frankfurt.de
-
Contact:
- Florian Giesche, M.Sc.
- Phone Number: 06979824482
- Email: Giesche@sport.uni-frankfurt.de
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- male (18 - 40 years, right-handed)
- sportive (preferably ball game sports, e.g. soccer)
Only cases:
- unilateral, primary anterior cruciate ligament tear and reconstruction (1-10yrs ago)
- no serious concomitant injuries (e.g. "unhappy triad")
- no kinesiophobia
- symmetric single leg jump performance (>85 %)
Exclusion Criteria:
- acute injury or life-quality impairing diseases
- any medication
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy Control
Age matched healthy subjects.
Inclusion criteria for healthy controls are: male (18 - 40 years, right-handed); sportive (preferably ball game sports, e.g.
soccer); no acute injury or life-quality impairing diseases; no medication
|
The study participants perform counter-movement jumps (CMJ, flight time approximately 500 ms) followed by single leg landings.
While under an anticipated condition, the individuals receive the visual information (presented on a screen) on which leg/ foot (left, right) they are required to land before self-initiated CMJs, the individuals will receive this information under the non-anticipated condition only after take-off (approximately 400 ms before ground contact).
|
Subjects with ACL reconstruction
Unilateral, primary anterior cruciate ligament tear and reconstruction (1 to 10 years ago); no serious concomitant injuries, e.g.
"unhappy triad"); no kinesiophobia; symmetric single leg jump performance (>85 %); male (18 - 40 years, right-handed); sportive (preferably ball game sports, e.g.
soccer); no acute injury or life-quality impairing diseases; no medication
|
The study participants perform counter-movement jumps (CMJ, flight time approximately 500 ms) followed by single leg landings.
While under an anticipated condition, the individuals receive the visual information (presented on a screen) on which leg/ foot (left, right) they are required to land before self-initiated CMJs, the individuals will receive this information under the non-anticipated condition only after take-off (approximately 400 ms before ground contact).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bereitschaftspotential - Movement planning associated cortical activity measures
Time Frame: Cross sectional design. Time Frame for Assessment of Movement planning associated cortical activity measures (Bereitschaftspotential, low beta-band power, frontal theta-band power) is 4 hours on one day
|
Determined via Electroencephalography as amplitude in microvolt [μV] and latency in milliseconds [ms] before initiation of jump movement
|
Cross sectional design. Time Frame for Assessment of Movement planning associated cortical activity measures (Bereitschaftspotential, low beta-band power, frontal theta-band power) is 4 hours on one day
|
Sensorimotor rhythm (SMR)/ low beta-band power - Movement planning associated cortical activity measures
Time Frame: Cross sectional design. Time Frame for Assessment of Movement planning associated cortical activity measures (Bereitschaftspotential, low beta-band power, frontal theta-band power) is 4 hours on one day
|
Determined via Electroencephalography in microvolt^2 [μV²]
|
Cross sectional design. Time Frame for Assessment of Movement planning associated cortical activity measures (Bereitschaftspotential, low beta-band power, frontal theta-band power) is 4 hours on one day
|
Frontal theta-band power - Movement planning associated cortical activity measures
Time Frame: Cross sectional design. Time Frame for Assessment of Movement planning associated cortical activity measures (Bereitschaftspotential, SMR/ low beta-band power, frontal theta-band power) is 4 hours on one day
|
Determined via Electroencephalography in microvolt^2 [μV²]
|
Cross sectional design. Time Frame for Assessment of Movement planning associated cortical activity measures (Bereitschaftspotential, SMR/ low beta-band power, frontal theta-band power) is 4 hours on one day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak ground reaction force - Biomechanical outcome measures of single leg jump-landings
Time Frame: Cross sectional design. Biomechanical outcome measures of single leg jump-landings are assessed simultaneously with primary outcome assessment (during same 4 hours on one day)
|
Determined via capacitive force platform: Biomechanical outcome measure of single leg jump-landing (Newton [N])
|
Cross sectional design. Biomechanical outcome measures of single leg jump-landings are assessed simultaneously with primary outcome assessment (during same 4 hours on one day)
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Time to stabilisation - Biomechanical outcome measures of single leg jump-landings
Time Frame: Cross sectional design. Biomechanical outcome measures of single leg jump-landings are assessed simultaneously with primary outcome assessment (during same 4 hours on one day)
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Determined via capacitive force platform: Biomechanical outcome measure of single leg jump-landing (seconds [s])
|
Cross sectional design. Biomechanical outcome measures of single leg jump-landings are assessed simultaneously with primary outcome assessment (during same 4 hours on one day)
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Center of pressure sway - Biomechanical outcome measures of single leg jump-landings
Time Frame: Cross sectional design. Biomechanical outcome measures of single leg jump-landings are assessed simultaneously with primary outcome assessment (during same 4 hours on one day)
|
Determined via capacitive force platform: Biomechanical outcome measure of single leg jump-landing (in millimeter [mm])^2 [μV²])
|
Cross sectional design. Biomechanical outcome measures of single leg jump-landings are assessed simultaneously with primary outcome assessment (during same 4 hours on one day)
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Visual perceptual ability - Lower cognitive function
Time Frame: Cross sectional design. Timeframe for Assessment is 5 minutes (during congnitive function assessment, separate day as primary outcome assessment)
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Determined via pen and paper tests: Trail Making Test A (Time for task completion in seconds [s])
|
Cross sectional design. Timeframe for Assessment is 5 minutes (during congnitive function assessment, separate day as primary outcome assessment)
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Reaction time/ processing speed - Lower cognitive function
Time Frame: Cross sectional design. Timeframe for Assessment is 10 minutes (during congnitive function assessment, separate day as primary outcome assessment)
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Determined via computer-based neuropsychological test (mean of the log10 transformed reaction times for correct responses in milliseconds [ms])
|
Cross sectional design. Timeframe for Assessment is 10 minutes (during congnitive function assessment, separate day as primary outcome assessment)
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Working memory - Higher cognitive function
Time Frame: Cross sectional design. Timeframe for Assessment is 10 minutes (during congnitive function assessment, separate day as primary outcome assessment)
|
Determined via computer-based neuropsychological test (One card learning test: Speed of performance (mean of the log10 transformed reaction times for correct responses) and Accuracy of performance (arcsine transformation of the square root of the proportion of correct responses); Digit Span Task: Number of correct reproduced digits)
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Cross sectional design. Timeframe for Assessment is 10 minutes (during congnitive function assessment, separate day as primary outcome assessment)
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Cognitive flexibility - Higher cognitive function
Time Frame: Cross sectional design. Timeframe for Assessment is 5 minutes (during congnitive function assessment, separate day as primary outcome assessment)
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Determined via pen and paper test: Trail-Making-Test B vs. A (time for task completion in seconds [s])
|
Cross sectional design. Timeframe for Assessment is 5 minutes (during congnitive function assessment, separate day as primary outcome assessment)
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Inhibitory control - Higher cognitive function
Time Frame: Cross sectional design. Timeframe for Assessment is 15 minutes (during congnitive function assessment, separate day as primary outcome assessment)
|
Determined via computer-based neuropsychological test: Stop-Signal-Task (Stop signal reaction time in milliseconds [ms])
|
Cross sectional design. Timeframe for Assessment is 15 minutes (during congnitive function assessment, separate day as primary outcome assessment)
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Interference control - Higher cognitive function
Time Frame: Cross sectional design. Timeframe for Assessment is 5 minutes (during congnitive function assessment, separate day as primary outcome assessment)
|
Determined via pen and paper test: Stroop-Test (Time for task completion in seconds [s])
|
Cross sectional design. Timeframe for Assessment is 5 minutes (during congnitive function assessment, separate day as primary outcome assessment)
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Kinesiophobia (subjective measure) - Potential confounder
Time Frame: Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
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Determined via questionnaire (Tampa scale)
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Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
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Self-reported knee function (subjective measure) - Potential confounder
Time Frame: Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
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Determined via questionnaire (Lysholm knee score)
|
Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
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Physical activities (subjective measure) - Potential confounder
Time Frame: Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
|
Determined via questionnaire (IPAQ)
|
Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
|
Sport activities (current and past; subjective measure) - Potential confounder
Time Frame: Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
|
Determined via questionnaire
|
Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
|
Risk behaviour (subjective measure) - Potential confounder
Time Frame: Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
|
Determined via questionnaire (DOSPERT scale)
|
Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
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Musculoskeletal injuries (current and past; subjective measure) - Potential confounder
Time Frame: Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
|
Determined via questionnaire
|
Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
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Single and both legs jump performance (objective measure) - Potential confounder
Time Frame: Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
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Determined via motor testing (in centimeter [cm])
|
Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
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Single leg jump symmetry (objective measure) - Potential confounder
Time Frame: Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
|
Determined via motor testing (in percent [%])
|
Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
|
Static postural control (objective measure) - Potential confounder
Time Frame: Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
|
Determined via motor testing (in millimeter [mm])
|
Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
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Visuomotor reaction time (objective measure) - Potential confounder
Time Frame: Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
|
Determined via computer-based neuropsychological test (in milliseconds [ms])
|
Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Winfried Banzer, Prof, Head of Department; Goethe University Department of Sports Medicine
Publications and helpful links
General Publications
- Giesche F, Vieluf S, Wilke J, Engeroff T, Niederer D, Banzer W. Cortical Motor Planning and Biomechanical Stability During Unplanned Jump-Landings in Males With ACL-Reconstruction. J Athl Train. 2021 Jul 30. doi: 10.4085/1062-6050-0544.20. Online ahead of print.
- Giesche F, Engeroff T, Wilke J, Niederer D, Vogt L, Banzer W. Neurophysiological correlates of motor planning and movement initiation in ACL-reconstructed individuals: a case-control study. BMJ Open. 2018 Sep 19;8(9):e023048. doi: 10.1136/bmjopen-2018-023048.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SpM2016-006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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