Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-02-23 @ 6:24 AM
Study NCT ID:
NCT04464902
Status:
UNKNOWN
Last Update Posted:
2020-07-09
First Post:
2020-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Knee Extension Constraint Rehabilitation After ACL 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': "Patients and investigator all don't know which group they participated in."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-06', 'studyFirstSubmitDate': '2020-06-30', 'studyFirstSubmitQcDate': '2020-07-06', 'lastUpdatePostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'walking speed', 'timeFrame': 'at 24 weeks after ACL reconstruction surgery.', 'description': 'Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.'}, {'measure': 'walking speed', 'timeFrame': 'at 36 weeks after ACL reconstruction surgery.', 'description': 'Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.'}, {'measure': 'walking speed', 'timeFrame': 'at 48 weeks after ACL reconstruction surgery.', 'description': 'Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.'}, {'measure': 'ground reaction force', 'timeFrame': 'at 24 weeks after ACL reconstruction surgery.', 'description': 'Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.'}, {'measure': 'ground reaction force', 'timeFrame': 'at 36 weeks after ACL reconstruction surgery.', 'description': 'Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.'}, {'measure': 'ground reaction force', 'timeFrame': 'at 48 weeks after ACL reconstruction surgery.', 'description': 'Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.'}, {'measure': 'knee flexion angle', 'timeFrame': 'at 24 weeks after ACL reconstruction surgery.', 'description': 'Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.'}, {'measure': 'knee flexion angle', 'timeFrame': 'at 36 weeks after ACL reconstruction surgery.', 'description': 'Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.'}, {'measure': 'knee flexion angle', 'timeFrame': 'at 48 weeks after ACL reconstruction surgery.', 'description': 'Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.'}, {'measure': 'the moment of knee extension in the gait cycle', 'timeFrame': 'at 24 weeks after ACL reconstruction surgery.', 'description': 'Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.'}, {'measure': 'the moment of knee extension in the gait cycle', 'timeFrame': 'at 36 weeks after ACL reconstruction surgery.', 'description': 'Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.'}, {'measure': 'the moment of knee extension in the gait cycle', 'timeFrame': 'at 48 weeks after ACL reconstruction surgery.', 'description': 'Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.'}], 'secondaryOutcomes': [{'measure': 'The International Knee Documentation Committee (IKDC) score', 'timeFrame': 'at 24 weeks after ACL reconstruction surgery.', '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.'}, {'measure': 'The International Knee Documentation Committee (IKDC) score', 'timeFrame': 'at 36 weeks after ACL reconstruction surgery.', '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.'}, {'measure': 'The International Knee Documentation Committee (IKDC) score', 'timeFrame': 'at 48 weeks after ACL reconstruction surgery.', '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', 'injury prevention', 'knee extension constraint'], 'conditions': ['Anterior Cruciate Ligament Injuries']}, 'descriptionModule': {'briefSummary': 'To develop new prevention programs for non-contact ACL injuries that do not require additional training time and assistance from a sports medicine professional personnel. A knee extension constraint will be utilized to patients who have undertaken ACL reconstruction.\n\nAnd to determine the effects of knee extension constraint rehabilitation on lower extremity biomechanics after ACL reconstruction surgery.', 'detailedDescription': 'Purpose Of exploring the biomechanical effect of knee extension constraint rehabilitation on rehabilitation after anterior cruciate ligament (ACL) reconstruction. Methods: Recruit 60 patients after ACL reconstruction. Divide them into three groups by random block method: Knee extension constraint rehabilitation group (wearing a brace with limitation of knee extension), Placebo group (wearing a brace without limitation of knee extension), and Control group (no brace is worn). The three groups of patients received the same rehabilitation training from 1 to 12 weeks after surgery, starting from week 13 and intervening on the first day of each week (wearing braces). Five tests were performed at the end of the 12th, 24th, 36th, and 48th weeks after surgery. Vicon system and force platform system will be synchronized used to test walking, jogging, side-cutting, and jumping; The Isokinetic dynamometer system will be used to test muscle strength. Outcome evaluation indicators and statistical methods: (1) Mixed design two-way analysis of variances will be used for the following indicators: approach run velocity and jump height; knee flexion angle at initial foot contact with the ground; knee extension moment at the time of peak impact poster ground reaction force, study group will be considered as an independent variable while testing time as the variable for repeated measurements. (2) The knee flexion, valgus-varus, and internal-external rotation angles, and extension, valgus-varus, and internal-external rotation moments of each leg during support phase of each movement will be expressed as functions of normalized movement time and leg (involved or uninvolved) using regression analysis with dummy variable. A dummy variable will be used to represent involved and uninvolved legs. A forward elimination procedure will be used to determine the best regression equations. The regression procedure will be stopped when the contributions of powers of n+1 and n+2 have no significant contribution to the overall regression. The contribution of the dummy variable in the regression will be an indication of asymmetry of the movements of involved and uninvolved legs. The effect of study group on movement asymmetry will be determined by comparing the contribution of dummy variables to the overall regression among study groups using a one-way ANOVA. The effects of study group and testing time on the ACL injury risk index will be determined for each knee in each movement using two-way ANOVA with mixed model. Study group will be considered as an independent variable while testing time as a repeated measure variable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have isolated ACL injury and receive ACL reconstruction surgery at Sports Medicine Center, 3rd Hospital of Beijing University, Beijing, China.\n* 18-35 years old\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': 'NCT04464902', 'briefTitle': 'The Effects of Knee Extension Constraint Rehabilitation After ACL Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'The Effects of Knee Extension Constraint Rehabilitation After ACL Reconstruction', 'orgStudyIdInfo': {'id': 'IR001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'knee extension constraint rehabilitation group', 'interventionNames': ['Device: brace1']}, {'type': 'OTHER', 'label': 'placebo group', 'interventionNames': ['Device: brace2']}, {'type': 'OTHER', 'label': 'control group', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'brace1', 'type': 'DEVICE', 'description': 'The brace1 can provide resistance when patients want to extend their knee.', 'armGroupLabels': ['knee extension constraint rehabilitation group']}, {'name': 'brace2', 'type': 'DEVICE', 'description': "The brace1 can't provide resistance when patients want to extend their knee.", 'armGroupLabels': ['placebo group']}, {'name': 'No Intervention', 'type': 'OTHER', 'description': "Control Group don't have any brace.", 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongshi Huang, Doctor', 'role': 'CONTACT', 'email': 'huanghs@bjmu.edu.cn', 'phone': '01082267565'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yuanyuan Yu, Bachler', 'role': 'CONTACT', 'email': 'YYY1091012@126.com', 'phone': '+8615201134356'}], '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'}}}}