Anterior Cruciate Ligament Reconstruction Clinical Trial
Official title:
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
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Goethe University Department of Sports Medicine | Frankfurt am Main | Hessen |
Lead Sponsor | Collaborator |
---|---|
Goethe University |
Germany,
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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