Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-27 @ 10:06 PM
Study NCT ID:
NCT04963361
Status:
UNKNOWN
Last Update Posted:
2021-07-15
First Post:
2021-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Fear of Movement After Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 121}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-09-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-08', 'studyFirstSubmitDate': '2021-06-27', 'studyFirstSubmitQcDate': '2021-07-08', 'lastUpdatePostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The occurrence of fear of movement', 'timeFrame': '2nd day post-operative', 'description': 'Score of Tampa for kinesiophobia(TSK) ranging from17-68.The higher score means the worse outcome'}], 'secondaryOutcomes': [{'measure': 'Hospital Ansiety and Depression Scale(HADS)', 'timeFrame': '2nd day post-operative', 'description': 'The score of HADS ranging from 0-48,the higher score means the worse outcome'}, {'measure': 'General Self Efficacy Scale(GSES)', 'timeFrame': '2nd day post-operative', 'description': 'The score of GSES,ranging from 1-40,the higher socre means the better outcome'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Total Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'Total knee arthroplasty is one of the effective methods for the treatment of end-stage osteoarthritis. Postoperative rehabilitation exercise is an important method for the recovery of knee joint function. Exercise fear refers to an enlarged psychological phenomenon that patients are afraid of sports leading to injury, which is not conducive to the functional exercise of patients and hinders the recovery of knee joint function', 'detailedDescription': 'Object: the purpose of this study is to investigate the occurrence of fear of movement after total knee arthroplasty and analyze its influencing factors, so as to provide theoretical basis for reducing the occurrence of fear of movement after total knee arthroplasty, promoting the rehabilitation exercise of patients and promoting the recovery of knee joint function.\n\nIn this study, 121 patients with total knee arthroplasty were investigated by questionnaire, including general demographic data, sports fear scale, anxiety and depression scale, self-efficacy scale and so on. Multivariate logistic regression was used to analyze the influencing factors of postoperative fear of exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients after total knee arthroplasty', 'eligibilityCriteria': "Inclusion Criteria:\n\n（1） meeting the criteria of knee arthritis established by American Society of rheumatology （ 2) Total knee arthroplasty was performed for the first time （ 3) Good Chinese reading and comprehension ability （ 4) The patient's condition was stable, and there were no serious diseases of the heart, lung, brain and other important organs （ 5) Informed of the study and signed informed consent.\n\nExclusion Criteria:\n\n（1）deep venous thrombosis of lower extremity （ 2) Other diseases affecting walking function （ 3) Suffering from cognitive or mental disorders （ 4) Had a history of knee surgery"}, 'identificationModule': {'nctId': 'NCT04963361', 'briefTitle': 'Study on Fear of Movement After Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'A Survey of Fear of Exercise and Its Influencing Factors in Patients After Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'M2021182'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'fear of movement group', 'description': 'The score of fear of movement scale was more than 37', 'interventionNames': ['Other: patients were exposed to fear of movement']}, {'label': 'non-fear of movement group', 'description': 'The score of fear of movement scale was no more than 37', 'interventionNames': ['Other: patients were not exposed to fear of movement']}], 'interventions': [{'name': 'patients were exposed to fear of movement', 'type': 'OTHER', 'description': 'Patients completed the questionnaires independently', 'armGroupLabels': ['fear of movement group']}, {'name': 'patients were not exposed to fear of movement', 'type': 'OTHER', 'description': 'Patients completed the questionnaires independently', 'armGroupLabels': ['non-fear of movement group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Taobao Li', 'role': 'CONTACT', 'phone': '13811397872'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Tao Li', 'role': 'CONTACT', 'email': 'tobetheone@126.com', 'phone': '13811397872'}], 'overallOfficials': [{'name': 'Tao Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}