Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-29 @ 2:27 AM
Study NCT ID:
NCT07163468
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2025-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuromusculoskeletal Alterations After ACL Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}, {'id': 'D001265', 'term': 'Athletic Injuries'}, {'id': 'D000092442', 'term': 'Kinesiophobia'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2025-09-01', 'studyFirstSubmitQcDate': '2025-09-01', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frontal EEG Theta/Beta Ratio', 'timeFrame': 'Single assessment on the study day (June-July 2025)', 'description': 'Cortical activity measured at F3 and F4 electrode sites using EEG (Nexus-10 system, Mind Media, Netherlands). Theta (4-8 Hz) and beta (13-21 Hz) power spectral densities were calculated and the ratio (theta/beta) was used as an indicator of attentional control. Higher ratios indicate reduced attention and cognitive efficiency.'}], 'secondaryOutcomes': [{'measure': 'Visual Reaction Time (ms)', 'timeFrame': 'Single assessment on the study day (June-July 2025)', 'description': 'Computer-based visual response task; mean reaction time (ms) computed across 5 valid trials after practice. Longer times indicate lower sensorimotor efficiency.'}, {'measure': 'Kinesiophobia (TSK-11 total score)', 'timeFrame': 'Single assessment on the study day (June-July 2025)', 'description': 'Tampa Scale of Kinesiophobia-11; 11 items, 1-4 Likert; total score 11-44. Higher scores indicate greater fear of movement/reinjury.'}, {'measure': 'Psychological Readiness to Return to Sport (ACL-RSI total score)', 'timeFrame': 'Single assessment on the study day (June-July 2025)', 'description': 'ACL-RSI questionnaire; 12 items scored 0-100; total reported as mean (0-100). Higher scores indicate greater psychological readiness.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anterior Cruciate Ligament', 'Kinesiophobia', 'Electroencephalography'], 'conditions': ['Anterior Cruciate Ligament Injuries', 'Sports Injury', 'Neurocognitive Function']}, 'referencesModule': {'references': [{'pmid': '41318585', 'type': 'DERIVED', 'citation': 'Kaya HB, Karaduman ZO, Akpinar S, Arican M, Saglam S, Aksit S, Koc M, Uludag V. Neuromusculoskeletal alterations after ACL reconstruction: a cross-sectional study of cortical activity, motor response, and psychological readiness. BMC Sports Sci Med Rehabil. 2025 Nov 29. doi: 10.1186/s13102-025-01450-6. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This study investigated how anterior cruciate ligament (ACL) injuries affect not only the knee joint but also brain activity, reaction speed, and psychological readiness to return to sports. A total of 60 male athletes, aged 18 to 30 years, were evaluated in three groups: healthy athletes, athletes who had undergone primary ACL reconstruction, and athletes who had undergone revision ACL reconstruction.\n\nThe study measured brain activity with electroencephalography (EEG), reaction time with a computer-based test, and psychological status with standardized questionnaires. The findings showed that athletes with revision ACL surgery had more difficulties in attention control, slower reaction times, and greater psychological barriers compared to the other groups.\n\nThese results suggest that ACL injuries and surgeries may influence not only physical recovery but also brain function and psychological readiness. The study highlights the importance of considering neuromuscular, cognitive, and emotional aspects when planning rehabilitation and return-to-sport decisions.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consisted of 60 male athletes aged 18 to 30 years. Participants were divided into three groups: healthy controls with no history of knee injury, athletes with primary ACL reconstruction, and athletes with revision ACL reconstruction. All were actively engaged in regular sports participation and had completed ACL rehabilitation at least 6 months prior to enrollment.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale athletes\n\nAge between 18 and 30 years\n\nRegular participation in amateur or professional sports\n\nCompletion of ACL rehabilitation (for surgical groups) at least 6 months before enrollment\n\nAbility to undergo EEG and reaction time testing\n\nProvision of signed informed consent\n\nExclusion Criteria:\n\nHistory of neurological or psychiatric conditions (e.g., epilepsy, ADHD, depression)\n\nAdditional lower extremity injuries or orthopedic surgeries\n\nMetal implants or scalp conditions incompatible with EEG\n\nUncorrected visual or auditory deficits\n\nSystemic illnesses (e.g., diabetes, multiple sclerosis, neuropathy)\n\nUse of psychoactive medication\n\nAny cognitive or physical limitation interfering with testing procedures\n\nFemale participants (to avoid hormonal confounding effects on EEG recordings)'}, 'identificationModule': {'nctId': 'NCT07163468', 'acronym': 'NEURO-ACL', 'briefTitle': 'Neuromusculoskeletal Alterations After ACL Injury', 'organization': {'class': 'OTHER', 'fullName': 'Duzce University'}, 'officialTitle': 'Neuromusculoskeletal Alterations After ACL Injury: A Cross-Sectional Study of Cortical Activity, Motor Response, and Psychological Readiness', 'orgStudyIdInfo': {'id': '2025/177'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Control Group', 'description': 'Athletes with no history of knee injury or surgery (n=20).'}, {'label': 'Primary ACL Reconstruction Group', 'description': 'Athletes who had undergone a single ACL reconstruction, with rehabilitation completed at least 6 months prior to enrollment (n=20).'}, {'label': 'Revision ACL Reconstruction Group', 'description': 'Athletes who had undergone at least two ACL surgeries including revision, with rehabilitation completed at least 6 months prior to enrollment (n=20).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '81620', 'city': 'Düzce', 'country': 'Turkey (Türkiye)', 'facility': 'Duzce University', 'geoPoint': {'lat': 40.83889, 'lon': 31.16389}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared because the dataset is small, contains sensitive neurophysiological and psychological information, and was collected under conditions that limit external data access. Data may be available in aggregated form upon reasonable request to the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duzce University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Veysel Uludag', 'investigatorAffiliation': 'Duzce University'}}}}