Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
Study NCT ID:
NCT07291505
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Investigation of Kinesiophobia in Conservative Distal Radius Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}, {'id': 'D000092442', 'term': 'Kinesiophobia'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}, 'targetDuration': '18 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2025-12-05', 'studyFirstSubmitQcDate': '2025-12-17', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tampa Scale of Kinesiophobia', 'timeFrame': 'At 12 and 18 weeks after injury', 'description': 'It is a 17-item scale scored using a 4-point Likert scale (1 = Strongly disagree, 4 = Strongly agree). A total score is calculated after reversing items 4, 8, 12, and 16. The individual receives a total score between 17 and 68. A high score on the scale indicates a high level of kinesiophobia.'}, {'measure': 'Goniometric measurement', 'timeFrame': 'At 12 and 18 weeks after injury', 'description': "Patients' forearm pronation and supination, as well as wrist flexion, extension, radial and ulnar deviation movements, will be measured using a universal goniometer."}, {'measure': 'Push-Off Test', 'timeFrame': 'At 12 and 18 weeks after injury', 'description': 'It determines the force that the person can exert on their injured limb. The measurement will be taken using a Jamar hand dynamometer. While the person is standing, with the shoulder at 30 degrees of extension and the elbow at 30 degrees of flexion, the measurement will be repeated three times and the average recorded in kilograms.'}, {'measure': 'Patient-Rated Wrist Evaluation', 'timeFrame': 'At 12 and 18 weeks after injury', 'description': 'It measures the severity of wrist pain and the level of disability in activities of daily living. The survey consists of two subsections with a total of 15 questions. Each question is answered on a scale of 0 to 10 (0 = no pain/difficulty; 10 = maximum pain felt/inability to perform). The scores for the pain and function sections are added together to determine the final score, which is calculated out of 100. A high score indicates a high level of pain and disability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tampa Scale of Kinesiophobia', 'distal radius fracture', 'wrist function', 'upper extremity weight bearing'], 'conditions': ['Distal Radius Fracture', 'Kinesiophobia', 'Functional Status']}, 'referencesModule': {'references': [{'pmid': '32379119', 'type': 'BACKGROUND', 'citation': 'Jayakumar P, Teunis T, Vranceanu AM, Lamb S, Ring D, Gwilym S. Early Psychological and Social Factors Explain the Recovery Trajectory After Distal Radial Fracture. J Bone Joint Surg Am. 2020 May 6;102(9):788-795. doi: 10.2106/JBJS.19.00100.'}, {'pmid': '34112544', 'type': 'BACKGROUND', 'citation': 'Goudie ST, Broll R, Warwick C, Dixon D, Ring D, McQueen M. The Association Between Psychological Factors and Outcomes After Distal Radius Fracture. J Hand Surg Am. 2022 Feb;47(2):190.e1-190.e10. doi: 10.1016/j.jhsa.2021.04.012. Epub 2021 Jun 8.'}]}, 'descriptionModule': {'briefSummary': "This study aimed to investigate the predictability of kinesiophobia on functional outcomes in conservatively treated patients with distal radius fractures. For this purpose, patients' level of kinesiophobia will be assessed using the Tampa Kinesiophobia Scale. To assess the functional status of patients, joint range of motion and upper extremity weight bearing measurements will be performed. Patients' functionality will be additionally assessed with the Patient Rated Wrist Evaluation Questionnaire."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Volunteers among the patients who were referred to the hand rehabilitation unit after being followed conservatively with a diagnosis of distal radius fracture in the hand surgery clinic of a university hospital will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having been treated conservatively with an isolated distal radius fracture diagnosis,\n* Having a cognitive level that allows one to understand assessment methods and apply instructions.\n\nExclusion Criteria:\n\n* Comorbid musculoskeletal-neurovascular injuries\n* Bilateral injuries'}, 'identificationModule': {'nctId': 'NCT07291505', 'briefTitle': 'The Investigation of Kinesiophobia in Conservative Distal Radius Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'Investigation of the Predictability of Kinesiophobia on Functional Outcomes in Conservatively Treated Distal Radius Fractures', 'orgStudyIdInfo': {'id': 'E-60116787-020-789644'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated conservatively with a diagnosis of distal radius fracture', 'interventionNames': ['Other: Questionnaire and Physical Exam']}], 'interventions': [{'name': 'Questionnaire and Physical Exam', 'type': 'OTHER', 'description': 'A goniometric assessment will be performed to measure the range of motion in the wrist-forearm joint, and a Push Off test will be conducted to measure the upper extremity weight-bearing capacity.\n\nAdditionally, the Tampa Scale of Kinesiophobia and Patient-Rated Wrist Evaluation Questionnaire will be administered to patients using a face-to-face assessment method.', 'armGroupLabels': ['Patients treated conservatively with a diagnosis of distal radius fracture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20170', 'city': 'Denizli', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Umut Eraslan, PhD', 'role': 'CONTACT', 'email': 'ueraslan@pau.edu.tr', 'phone': '+905444126520'}], 'facility': 'Pamukkale University', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}], 'centralContacts': [{'name': 'Umut Eraslan, PhD', 'role': 'CONTACT', 'email': 'ueraslan@pau.edu.tr', 'phone': '+905444126520'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'UMUT ERASLAN', 'investigatorAffiliation': 'Pamukkale University'}}}}