Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2025-12-27 @ 4:06 PM
Study NCT ID:
NCT05929261
Status:
UNKNOWN
Last Update Posted:
2023-11-08
First Post:
2023-06-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stress Response to Virtual Risky Movement Exposure and Kinesiophobia After Anterior Cruciate Ligament (ACL) Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092442', 'term': 'Kinesiophobia'}, {'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-07', 'studyFirstSubmitDate': '2023-06-15', 'studyFirstSubmitQcDate': '2023-06-26', 'lastUpdatePostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Kinesiophobia Status - Anterior Cruciate Ligament - Return to Sport after Injury (ACL-RSI) scale', 'timeFrame': 'From 0 to 6 months', 'description': 'ACL-RSI scale evaluates psychological readiness to return to sports participation after ACL reconstruction and has items related to fear of reinjury/accidental injury during sport activities.\n\nThe scale contains 12 questions and each question is scored from 0 to 100 in 10-point increments according to the visual analog scale. The scale score is calculated by adding the scores from all 12 questions and dividing by 12. A high score on the scale indicates a positive psychological response.'}, {'measure': 'Physiological Stress Responses - Heart Rate Variability (HRV) Metrics', 'timeFrame': 'From 0 to 6 months', 'description': 'Metrics will be measured with Shimmer 3 GSR Development and Consensys GSR Development Kit. Low Frequency (LF), High Frequency (HF), Low Frequency to High Frequency ratio (LF/HF), root mean square of successive differences (RMMSD) will be measured from participants while watching stress evoking videos. Metrics will be measured according to the Task Force guidelines in 1996. RMSSD reflects the integrity of vagus nerve-mediated autonomic control of the heart, HF reflects parasympathetic activity, and LF is proportional to sympathetic activity but influenced by parasympathetic tone. LF/HF reflects sympathetic activity dominancy over parasympathetic activity.'}, {'measure': 'Physiological Stress Responses - Galvanic Skin Response (GSR) Metrics', 'timeFrame': 'From 0 to 6 months', 'description': 'Metrics will be measured with Shimmer 3 GSR Development and Consensys GSR Development Kit. Skin conductance response (SCR) will be measured from participants while watching stress evoking videos. SCR is the measurement of the electrical conductivity of the skin and represents the activation of sweat glands in response to a particular stressor stimuli.'}, {'measure': 'Functional Tests Landing Error Scoring System (LESS) score', 'timeFrame': 'From 0 to 6 months', 'description': 'Participants will be tested for their landing with a standardized jump-landing from a box task. Subjects will jump down from the box and land on the ground and then immediately jump vertically upward as high as possible. We will rate for every participant by observing in both the sagittal and the frontal plane of jump- landing technique while the subject was in contact with the ground after landing from the box.\n\nScoring will be made as "No" (0 points) and "Yes" (1 point) for Items 1-15. For Item16, it will be evaluated as "Excellent" (0 points), "Average" (1 point) and "Hard" (2 points). For item 17, "Excellent" (0 points), "Average" (1 point) and "Bad" (2 points). The total score of 17 items will be evaluated. The higher the score obtained from the test result, the worse the jump landing. LESS scores will be interpreted in four different categories: excellent (LESS score \\<4), good (4\\<LESS score ≤5), moderate (5\\<LESS score ≤6), and poor (LESS score \\>6).'}, {'measure': 'Functional Tests - Hop tests (single legged)', 'timeFrame': 'From 0 to 6 months', 'description': 'Participants will be tested for leg hop tests which described in the literature by Ross et al. 2002. \\>10% difference between tested legs will be considered as asymmetry.\n\nSingle Hop for Distance. Subjects will be instructed to hop as far as possible forward and land on the same leg. The distance from the starting line to the point where the subject is landed will be measured.\n\nTriple Hop for Distance. Subjects will be instructed to take 3 maximal hops forward with the designated leg. The distance from the starting line to the point where the subject is landed will be measured.\n\nCrossover Hop for Distance. Subjects will be instructed to take 3 maximal hops while crossing over a line each time. The distance from the starting line to the point where the subject is landed will be measured.\n\nSix Meter Hop for Time. Subjects will be instructed to hop 6m distance as quickly as possible with the designated leg. Time will be measured from start to the time the subject crossed the finish line.'}, {'measure': 'Functional Tests - T-test', 'timeFrame': 'From 0 to 6 months', 'description': 'For each participant, a running t test will be performed, which will evaluate their agility during running with changes of direction. Participants will be asked to run forward for 10 m, then change to side-steps to the right for 5 m, then 10 m of side-steps to the left, followed by 5 m of side- steps to the right, ending with 10 m of backwards running. Three repetitions will be performed at maximum speed and the average time for the three repetitions will be calculated.\n\nCompleting the test in less than 11 seconds will be classified as high agility, and finishing in 11 seconds or more will be classified as low agility.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kinesiophobia', 'Anterior Cruciate Ligament Injuries', 'Virtual Reality', 'Stress', 'Athlete', 'Sports Medicine'], 'conditions': ['Kinesiophobia', 'Anterior Cruciate Ligament Injuries']}, 'descriptionModule': {'briefSummary': "In this study, patients who have completed their rehabilitation after Anterior Cruciate Ligament (ACL) reconstruction surgery will be examined with physiological stress response test while being exposed to risky athletic movements via virtual reality headsets. In the next, step patients' functional performance tests will be examined and their relation with stress responses will be examined."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study group consists of subjects who had ACL reconstruction surgery and willing to return to sports activities.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Study Group:\n\n* 18 years or older\n* Male gender\n* Having history of isolated unilateral ACL reconstruction surgery\n* Physician clearance for unrestricted physical activity after having at least 6-months of rehabilitation following surgery\n* Willing to return to sports that require cutting and landing motions\n* Not having any sports injuries past three months\n* Not having any previous orthopaedic surgery other than ACL reconstruction surgery\n\nInclusion Criteria for Control Group:\n\n* 18 years or older\n* Male gender\n* Playing sports that require cutting and landing motions\n* Physician clearance for unrestricted physical activity\n* Not having any sports injuries past three months\n* Not having any previous orthopaedic surgery\n\nExclusion Criteria for Study Group:\n\n* Having a reinjury during rehabilitation\n* Having multiple ligament injuries before the surgery\n* Diagnosed with knee osteoarthritis\n* Diagnosed with knee cartilage injury\n* Diagnosed with meniscus tear\n\nExclusion Criteria for Control Group:\n\n* Diagnosed with ACL injury\n* Diagnosed with knee osteoarthritis\n* Diagnosed with knee cartilage injury\n* Diagnosed with meniscus tear'}, 'identificationModule': {'nctId': 'NCT05929261', 'briefTitle': 'Stress Response to Virtual Risky Movement Exposure and Kinesiophobia After Anterior Cruciate Ligament (ACL) Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'Stress Response to Virtual Exposure to Risky Movements After Anterior Cruciate Ligament (ACL) Rehabilitation and Its Relationship With Kinesiophobia', 'orgStudyIdInfo': {'id': '22-12.2Tl31'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Group', 'description': 'Study group will be examined for outcome measurements.'}, {'label': 'Control Group', 'description': 'Control group will be examined for outcome measurements.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35100', 'city': 'Izmir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ogün Köyağasıoğlu', 'role': 'CONTACT', 'email': 'ogunkoyagasioglu@gmail.com', 'phone': '02323902378'}], 'facility': 'Ege University Faculty of Medicine', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'centralContacts': [{'name': 'Ogun Koyagasioglu, MD', 'role': 'CONTACT', 'email': 'ogunkoyagasioglu@gmail.com', 'phone': '+90 232 390 23 78'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD Candidate, Director of the project', 'investigatorFullName': 'Ogun Koyagasioglu', 'investigatorAffiliation': 'Ege University'}}}}