Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-06 @ 7:04 AM
Study NCT ID:
NCT06485934
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2024-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kinesiophobia Scale for the Upper Extremity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D000092442', 'term': 'Kinesiophobia'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2024-06-27', 'studyFirstSubmitQcDate': '2024-06-27', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Multidimensional Kinesiophobia Scale (To be developed)', 'timeFrame': 'Baseline of the study', 'description': 'It is desired to be developed to evaluate the fear of movement that occurs due to upper extremity injuries.'}, {'measure': 'Multidimensional Kinesiophobia Scale (To be developed)', 'timeFrame': '5-7 days after baseline assessment', 'description': 'It is desired to be developed to evaluate the fear of movement that occurs due to upper extremity injuries.'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': 'Baseline of the study', 'description': 'Assesses pain severity. It scores between 0-10 points. A high score indicates high pain intensity.'}, {'measure': 'Tampa Kinesiophobia Scale', 'timeFrame': 'Baseline of the study', 'description': 'It consists of 17 items. Assesses the fear of movement. Total score is 68 points. A high score indicates high fear.'}, {'measure': 'Demographic Data Form', 'timeFrame': 'Baseline of the study', 'description': 'This form was created by researchers and it consist of personal informations such as gender, marital status, education, age, body mass index, dominant and affected extremity, name of pathology,'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kinesiophobia', 'Shoulder', 'Development of Scale'], 'conditions': ['Shoulder Injuries']}, 'descriptionModule': {'briefSummary': 'Questionnaires/scales used to evaluate kinesiophobia in the literature are limited and are not specific to the upper extremity in existing scales. For this reason, the primary purpose and subject of the study is to develop a multi-factor kinesiophobia scale specific to shoulder problems.\n\nThe study is an observational research. Participants will be interviewed twice in total. All primary and secondary outcomes will be assessed at the first meeting. The second come will be performed within 5-7 days after the first assessment. In the second come, only the new kinesiophobia scale that is intended to be developed will be applied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Traumatological, orthopedic and rheumatological pathologies that cause fear of movement in the upper extremity', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Tampa Kinesiophobia Score \\>37 points\n* Presence of traumatological, orthopedic and rheumatological pathology in the upper extremity\n* Mini-Mental State Examination score \\>24 points\n\nExclusion Criteria:\n\n* Malignancy,\n* Psychiatric drug use,\n* Use of painkillers during evaluation periods,\n* Those who received physiotherapy before the study (last 6 months),\n* Those whose education level is below secondary school level,'}, 'identificationModule': {'nctId': 'NCT06485934', 'briefTitle': 'Kinesiophobia Scale for the Upper Extremity', 'organization': {'class': 'OTHER', 'fullName': 'Karadeniz Technical University'}, 'officialTitle': 'Development of the Multidimensional Kinesiophobia Scale for the Upper Extremity: A Scale Development Study', 'orgStudyIdInfo': {'id': '2024/74'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational Group', 'description': 'All of the outcomes will be applied to patients who come to the outpatient clinic due to shoulder problems. Then, 1 week later, participants will be recalled to apply the multidimensional kinesiophobia scale a second time.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34104', 'city': 'Istanbul', 'status': 'NOT_YET_RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ozan Tuncel', 'role': 'CONTACT', 'email': 'info@elcerrahi.com', 'phone': '+90 531 885 5844'}, {'name': 'Ozan Tuncel, MsC', 'role': 'CONTACT', 'email': 'fztozantuncel@gmail.com', 'phone': '+90 533 321 18 32'}], 'facility': 'Clinic of İstanbul Hand-Microsurgery Rehabilitation', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ozan Tuncel, Physiotherapist', 'role': 'CONTACT', 'email': 'fztozantuncel@gmail.com', 'phone': '+905533211832'}], 'facility': 'Clinic of İstanbul Hand-Microsurgery Rehabilitation', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Emre Şenocak, PhD', 'role': 'CONTACT', 'email': 'emre.senocak@windowslive.com', 'phone': '+90 553 569 56 92'}, {'name': 'Aysel Yıldız Özer, Professor', 'role': 'CONTACT', 'email': 'aysel.yildiz@marmara.edu.tr', 'phone': '+90 533 467 44 33'}], 'overallOfficials': [{'name': 'Abdurrahman Tanhan, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Bitlis Eren University'}, {'name': 'Zeynep Hoşbay, Associate Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Biruni University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emre Şenocak', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Emre Şenocak', 'investigatorAffiliation': 'Karadeniz Technical University'}}}}