Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-01-01 @ 11:52 AM
Study NCT ID:
NCT04462432
Status:
UNKNOWN
Last Update Posted:
2020-07-08
First Post:
2020-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spatiotemporal Characteristics and Multi-body Dynamics Modeling Information After ACL Rupture and Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-06', 'studyFirstSubmitDate': '2020-06-30', 'studyFirstSubmitQcDate': '2020-07-06', 'lastUpdatePostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'walking speed', 'timeFrame': 'On the day of enrollment.', 'description': 'Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.'}, {'measure': 'walking speed', 'timeFrame': 'at 24th weeks after Anterior Cruciate Ligament reconstruction.', 'description': 'Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.'}, {'measure': 'walking speed', 'timeFrame': 'at 48th weeks after Anterior Cruciate Ligament reconstruction.', 'description': 'Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.'}, {'measure': 'ground reaction force', 'timeFrame': 'On the day of enrollment.', 'description': 'Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.'}, {'measure': 'ground reaction force', 'timeFrame': 'at 24th weeks after Anterior Cruciate Ligament reconstruction.', 'description': 'Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.'}, {'measure': 'ground reaction force', 'timeFrame': 'at 48th weeks after Anterior Cruciate Ligament reconstruction.', 'description': 'Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.'}, {'measure': 'knee flexion angle', 'timeFrame': 'On the day of enrollment.', 'description': 'Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.'}, {'measure': 'knee flexion angle', 'timeFrame': 'at 24th weeks after Anterior Cruciate Ligament reconstruction.', 'description': 'Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.'}, {'measure': 'knee flexion angle', 'timeFrame': 'at 48th weeks after Anterior Cruciate Ligament reconstruction.', 'description': 'Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.'}, {'measure': 'the moment of knee extension in the gait cycle', 'timeFrame': 'On the day of enrollment.', 'description': 'Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.'}, {'measure': 'the moment of knee extension in the gait cycle', 'timeFrame': 'at 24th weeks after Anterior Cruciate Ligament reconstruction.', 'description': 'Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.'}, {'measure': 'the moment of knee extension in the gait cycle', 'timeFrame': 'at 48th weeks after Anterior Cruciate Ligament reconstruction.', 'description': 'Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.'}, {'measure': 'the moment of knee flexion in the gait cycle', 'timeFrame': 'On the day of enrollment.', 'description': 'Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.'}, {'measure': 'the moment of knee flexion in the gait cycle', 'timeFrame': 'at 24th weeks after Anterior Cruciate Ligament reconstruction.', 'description': 'Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.'}, {'measure': 'the moment of knee flexion in the gait cycle', 'timeFrame': 'at 48th weeks after Anterior Cruciate Ligament reconstruction.', 'description': 'Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.'}], 'secondaryOutcomes': [{'measure': 'The International Knee Documentation Committee (IKDC) score', 'timeFrame': 'On the day of enrollment, at 24th and 48th weeks after Anterior Cruciate Ligament reconstruction.', 'description': 'The International Knee Documentation Committee (IKDC) score was used to evaluate the knee health.The patients completed score by themselves. The lowest score is 0 and the highest score is 100.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anterior cruciate ligament', 'gait analysis', 'plantar pressure', 'multi-body dynamics modeling'], 'conditions': ['Anterior Cruciate Ligament Injuries']}, 'descriptionModule': {'briefSummary': 'High incidence rate of knee osteoarthritis and gait analysis are important for early assessment of biomechanics. ACL injury is an ideal clinical model for studying knee osteoarthritis.\n\nTo clarify the mechanism between the biomechanical status of knee joint and the change of gait touch information, and to provide scientific basis for quantifying and evaluating the biomechanical status of knee joint in dynamic load-bearing state.', 'detailedDescription': 'Purpose: To clarify the relationship between the normal and abnormal biomechanical status of the knee joint and the gait touch information, and to establish the biomechanical evaluation model of the knee joint during walking or jogging, taking into account the comprehensive effects of sports parameters, individual attribute parameters and other factors. An automatic analysis and expert diagnosis system was established to evaluate the biomechanics of knee joint.\n\nMethods: 50 young male (23-35 years old) healthy volunteers and 100 patients with unilateral simple ACL rupture who need surgical treatment were recruited, 150 subjects in total. Three tests were performed before surgery, at the end of the 24th and 48th weeks after surgery. All were tested with three-dimensional gait analysis, dynamic plantar pressure measurement and isokinetic muscle strength during walking, jogging, emergency stop and take-off, side cut.\n\nOutcome evaluation indicators and statistical methods: Two-way ANOVA method of repeated measurement was used, the left and right sides and different rehabilitation time were used as the variables of repeated measurement: the biomechanics of the lower limb joint and the change of the biological characteristics of the gait touch information were analyzed. Three dimensional gait analysis and computer-aided analysis of gait touch information were used to study the changes of ACL rupture and reconstruction. Based on the information of gait touch, taking into account the comprehensive effects of sports parameters, individual attribute parameters and other factors, a biomechanical evaluation model of knee joint during walking or jogging is established, which provides the exact basis for quantifying the information of gait touch and evaluating the biomechanical state of knee joint after ACL rupture and reconstruction under dynamic load-bearing state, and establishes a clinical practical automatic analysis and expert diagnosis system of gait touch information to evaluate the biomechanics of the knee joint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inclusion criteria: Age: 18-35 years old. Patients who have isolated ACL injury and receive ACL reconstruction surgery at Peking University Third Hospital. With isolated ACL injury (an ACL injury with no need for surgical repairs to other knee structures). All participants have no known disorders or diseases other than ACL rupture.\n\nExclusion criteria: Female patients who are pregnant, or suspected pregnant, or in breastfeeding will be excluded from this study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-35 years old\n* Patients who have isolated ACL injury and receive ACL reconstruction surgery at Peking University Third Hospital.\n* With isolated ACL injury (an ACL injury with no need for surgical repairs to other knee structures).\n* All participants have no known disorders or diseases other than ACL rupture.\n\nExclusion Criteria:\n\n* Female patients who are pregnant, or suspected pregnant, or in breastfeeding will be excluded from this study.'}, 'identificationModule': {'nctId': 'NCT04462432', 'briefTitle': 'Spatiotemporal Characteristics and Multi-body Dynamics Modeling Information After ACL Rupture and Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Spatiotemporal Characteristics and Multi-body Dynamics Modeling of Gait Touch Information After Anterior Cruciate Ligament Rupture and Reconstruction', 'orgStudyIdInfo': {'id': 'OR003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anterior Cruciate Ligament injury and reconstruction group', 'description': 'According to the previous clinical diagnosis, volunteers who has never suffered the Anterior Cruciate Ligament injury.', 'interventionNames': ['Other: no intervention']}, {'label': 'normal control group', 'description': 'According to the previous clinical diagnosis, volunteers who has never suffered the lower extremity sports injuries.', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'This is an observation study, with no intervention.', 'armGroupLabels': ['Anterior Cruciate Ligament injury and reconstruction group', 'normal control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Hongshi Huang, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}