Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-01-03 @ 4:38 AM
Study NCT ID:
NCT07243912
Status:
COMPLETED
Last Update Posted:
2025-11-24
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Balance Evaluation in Adult Hemophilia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D000092442', 'term': 'Kinesiophobia'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-21', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Static and Dynamic Balance Assessment', 'timeFrame': 'From enrollment to at 4 weeks', 'description': 'Static and dynamic balance assessments were performed using the Pro-kin Technobody Posturographic Platform (Pro-kin 212, Technobody s.r.l., Dalmine, 21044 Bergamo, Italy). Static balance was assessed using the "Static Stability Test." This test is based on the subject\'s oscillations on the force platform, assessing the movement of the center of pressure, and the trunk sensor measuring trunk oscillation. Dynamic balance will be assessed using the Limits of Stability test. For the LoS test, a medium difficulty level (20 levels) will be selected from the 5-10-20-30-40 difficulty levels. Participants will be asked to orient their center of gravity toward eight directional targets for a limited time.'}], 'secondaryOutcomes': [{'measure': 'Joint Health', 'timeFrame': 'From enrollment to 4 weeks', 'description': 'This was assessed with Hemophilia Joint Health Score (HJHS). The HJHS evaluates the knee, elbow, and ankle index joints bilaterally and includes a walking score. Each joint can receive a maximum of 20 points, with a maximum walking score of 4 points (total score = 124). A higher score indicates poor joint health. Since the elbow joint score will not be used in this study, the maximum score was determined as 84.'}, {'measure': 'Physical Activity Level', 'timeFrame': 'From enrollment to 4 weeks', 'description': 'Physical activity was evaluated with the International Physical Activity Questionnaire (IPAQ) Short Form. The IPAQ short form consists of seven questions to be answered by the patient and asks about the duration and frequency of each activity performed during the past week. The total score is calculated in MET-min/week by multiplying the MET values defined for walking (3.3 METs), moderate-intensity physical activity (4.0 METs), and vigorous-intensity physical activity (8.0 METs) by the duration (minutes) and frequency (days). Sitting is not included in the score. High scores indicate high physical activity.'}, {'measure': 'Kinesiophobia', 'timeFrame': 'From enrollment to 4 weeks', 'description': 'Kinesiophobia will be assessed with the Tampa Scale for Kinesiophobia. Kinesiophobia is defined as the fear of reinjury and movement due to chronic pain. It consists of 17 questions, with total scores ranging 17-68. The higher the score is the gretaer the level of kinesiophobia, and scores above 37 are considered high kinesiophobia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hemophilia', 'postural balance', 'musculoskeletal disease', 'physical activity', 'kinesiophobia'], 'conditions': ['Postural Balance']}, 'descriptionModule': {'briefSummary': "Introduction: Recurrent hemarthrosis in hemophilia can cause deterioration of static and dynamic balance in hemophilia. Studies in AwH report decreased dynamic balance, but consistent results regarding static balance are lacking. The causes of the decrease in dynamic balance and its associated parameters have been under explored.\n\nAim: To investigate static and dynamic balance in AwH compared to healthy controls and factors such as joint health, physical activity and kinesiophobia that may affect dynamic balance.\n\nMethods: This cross-sectional controlled study included 41 AwH and 40 healthy controlled, totally 81 man and study groups determined as Hemophilia Group (HG) and Control Group (CG). Static (Static Stability Test) and dynamic balance (Limits of Stability Test (LoS) Test) were assessed Pro-kin Technobody Posturographic Platform; physical activity level with International Physical Activity Questionnaire (IPAQ) for all groups. Joint health and kinesiophobia were assessed with Hemophilia Joint Health Score and Tampa Scale for Kinesiophobia (TSK) for HG, respectively. Participants' age, height and weight were questioned in both groups, as well as type and severity of hemophilia, type of treatment, and work/job status in HG."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Hemophilia patients and healthy volunteers', 'genderDescription': 'Since hemophilia is a hereditary disease seen in males, only males were included in the control group.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nSevere or moderate hemophilia A or B\n\nExclusion Criteria:\n\nDiabetus mellitus, hemiplegia, rheumatoid arthritis, Alzheimer's disease, Parkinson's disease, all vestibular system pathologies, lower extremity surgery within the last 6 months, using a walking aid."}, 'identificationModule': {'nctId': 'NCT07243912', 'briefTitle': 'Balance Evaluation in Adult Hemophilia', 'organization': {'class': 'OTHER', 'fullName': 'Yuzuncu Yil University'}, 'officialTitle': 'Evaluation of Static and Dynamic Balance, and the Effects of Joint Health, Physical Activity and Kinesiophobia on Dynamic Balance in Adult With Hemophilia.', 'orgStudyIdInfo': {'id': 'YuzuncuYil2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control Group', 'description': 'Healthy individual', 'interventionNames': ['Diagnostic Test: Postural balance assessment']}, {'label': 'Hemophilia Group', 'description': 'Adults with Hemophilia', 'interventionNames': ['Diagnostic Test: Postural balance assessment']}], 'interventions': [{'name': 'Postural balance assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'Static and dynamic balance was analyzed with the posturographic platform.', 'armGroupLabels': ['Control Group', 'Hemophilia Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65080', 'city': 'Van', 'state': 'Tuşba', 'country': 'Turkey (Türkiye)', 'facility': 'Van Yüzüncü Yıl University', 'geoPoint': {'lat': 38.49457, 'lon': 43.38323}}], 'overallOfficials': [{'name': 'Ayşe M Tat, Asst Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yuzuncu Yil University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ayse Merve TAT', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ayse Merve TAT', 'investigatorAffiliation': 'Yuzuncu Yil University'}}}}