Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-04-23 @ 1:41 PM
Study NCT ID:
NCT04961892
Status:
COMPLETED
Last Update Posted:
2021-07-14
First Post:
2021-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Difference of Plantar Pressure Distribution Between Surgical Treatment and Conservative Treatment for CAI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000072700', 'term': 'Conservative Treatment'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-04', 'studyFirstSubmitDate': '2021-06-25', 'studyFirstSubmitQcDate': '2021-07-04', 'lastUpdatePostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FAAM', 'timeFrame': 'pre-surgery, one year after sugery', 'description': 'Foot and Ankle Ability Measure Activity'}], 'secondaryOutcomes': [{'measure': 'IDFAI', 'timeFrame': 'pre-surgery, one year after sugery', 'description': 'Identification of Functional Ankle Instability questionnaire'}, {'measure': 'Ligament injury by MRI', 'timeFrame': 'pre-surgery, one year after sugery', 'description': 'To evaluate the condition of lateral collateral ligament using magnetic resonance imaging'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Ankle Instability']}, 'descriptionModule': {'briefSummary': 'The objective of this study was to compare the difference of plantar pressure distribution between surgical treatment and conservative treatment for CAI.', 'detailedDescription': 'The data of 20 patients who underwent surgery after reconstruction of the lateral collateral ligament of the ankle joint and 20 patients who underwent balance rehabilitation training were analyzed to compare the clinical effects of surgical treatment and conservative treatment for chronic ankle instability, in order to better guide the selection of the optimal intervention program for patients with chronic ankle joint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'From April 1, 2019, information of 20 patients diagnosed with CAI that underwent surgical treatment in our institute and 20 patients that underwent conservative treatment was collected and evaluated.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with CAI\n* The contralateral ankle joint is healthy\n\nExclusion Criteria:\n\n* Accompanied by other musculoskeletal injuries'}, 'identificationModule': {'nctId': 'NCT04961892', 'briefTitle': 'Difference of Plantar Pressure Distribution Between Surgical Treatment and Conservative Treatment for CAI', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Difference of Plantar Pressure Distribution Between Surgical Treatment and Conservative Treatment for Chronic Ankle Instability', 'orgStudyIdInfo': {'id': 'M2019164'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'surgical treatment', 'description': 'Patients with CAI undergoing surgical treatment', 'interventionNames': ['Procedure: surgical treatment']}, {'label': 'conservative treatment', 'description': 'Patients with CAI undergoing conservative treatment', 'interventionNames': ['Procedure: conservative treatment']}], 'interventions': [{'name': 'surgical treatment', 'type': 'PROCEDURE', 'description': 'Anatomical contraction and termination reconstruction of the lateral ligament', 'armGroupLabels': ['surgical treatment']}, {'name': 'conservative treatment', 'type': 'PROCEDURE', 'description': 'Rehabilitation intervention training', 'armGroupLabels': ['conservative treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Yuelin Hu, bachelor', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}