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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03336060
Other study ID # SpM2016-006
Secondary ID
Status Recruiting
Phase N/A
First received October 27, 2017
Last updated March 14, 2018
Start date October 1, 2017
Est. completion date June 30, 2018

Study information

Verified date March 2018
Source Goethe University
Contact Winfried Banzer, Prof
Phone 06979824482
Email Banzer@sport.uni-frankfurt.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To examine the long-term effects of anterior cruciate ligament injuries and reconstructions (after successful rehabilitation) on cortical processes of motor planning during complex jump landing tasks and the relevance of cognitive performance measures for landing stability, respectively knee injury risk.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date June 30, 2018
Est. primary completion date May 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Anterior Cruciate Ligament Reconstruction

Intervention

Diagnostic Test:
Cortical Correlates of Jump Landing Task
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).

Locations

Country Name City State
Germany Goethe University Department of Sports Medicine Frankfurt am Main Hessen

Sponsors (1)

Lead Sponsor Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bereitschaftspotential - Movement planning associated cortical activity measures 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
Primary Sensorimotor rhythm (SMR)/ low beta-band power - Movement planning associated cortical activity measures 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
Primary Frontal theta-band power - Movement planning associated cortical activity measures 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 Peak ground reaction force - Biomechanical outcome measures of single leg jump-landings 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)
Secondary Time to stabilisation - Biomechanical outcome measures of single leg jump-landings 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)
Secondary Center of pressure sway - Biomechanical outcome measures of single leg jump-landings 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)
Secondary Visual perceptual ability - Lower cognitive function 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)
Secondary Reaction time/ processing speed - Lower cognitive function 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)
Secondary Working memory - Higher cognitive function 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) Cross sectional design. Timeframe for Assessment is 10 minutes (during congnitive function assessment, separate day as primary outcome assessment)
Secondary Cognitive flexibility - Higher cognitive function 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)
Secondary Inhibitory control - Higher cognitive function 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)
Secondary Interference control - Higher cognitive function 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)
Secondary Kinesiophobia (subjective measure) - Potential confounder Determined via questionnaire (Tampa scale) Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
Secondary Self-reported knee function (subjective measure) - Potential confounder Determined via questionnaire (Lysholm knee score) Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
Secondary Physical activities (subjective measure) - Potential confounder Determined via questionnaire (IPAQ) Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
Secondary Sport activities (current and past; subjective measure) - Potential confounder Determined via questionnaire Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
Secondary Risk behaviour (subjective measure) - Potential confounder Determined via questionnaire (DOSPERT scale) Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
Secondary Musculoskeletal injuries (current and past; subjective measure) - Potential confounder Determined via questionnaire Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
Secondary Single and both legs jump performance (objective measure) - Potential confounder Determined via motor testing (in centimeter [cm]) Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
Secondary Single leg jump symmetry (objective measure) - Potential confounder Determined via motor testing (in percent [%]) Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
Secondary Static postural control (objective measure) - Potential confounder Determined via motor testing (in millimeter [mm]) Cross sectional design. Time Frame for Assessments is 5 minutes (same day as cognitive function assessment)
Secondary Visuomotor reaction time (objective measure) - Potential confounder 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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