Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-30 @ 7:36 AM
Study NCT ID:
NCT05802368
Status:
COMPLETED
Last Update Posted:
2023-04-06
First Post:
2023-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemophilic Knee Arthropathy Virtual Reality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-27', 'studyFirstSubmitDate': '2023-03-27', 'studyFirstSubmitQcDate': '2023-03-27', 'lastUpdatePostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gait Analysis', 'timeFrame': 'at first week', 'description': 'Each participant was instructed to walk bare feet with a comfortable, self-selected speed along a 10-meter walkway while the trajectories of reflective markers and forces were respectively recorded through 12 optoelectronic cameras (Vicon Motion Systems Ltd., Oxford, UK) with a 120-Hz sampling rate and two force plates at 1000 Hz.'}, {'measure': 'Gait Analysis', 'timeFrame': 'after 12 weeks', 'description': 'Each participant was instructed to walk bare feet with a comfortable, self-selected speed along a 10-meter walkway while the trajectories of reflective markers and forces were respectively recorded through 12 optoelectronic cameras (Vicon Motion Systems Ltd., Oxford, UK) with a 120-Hz sampling rate and two force plates at 1000 Hz.'}], 'secondaryOutcomes': [{'measure': 'Functional ability assessment', 'timeFrame': 'at first week', 'description': 'The 6-minute walk test was used to assess functional abilities.'}, {'measure': 'Functional ability assessment', 'timeFrame': 'after 12 weeks', 'description': 'The 6-minute walk test was used to assess functional abilities.'}, {'measure': 'Physical activity level assessment', 'timeFrame': 'at first week', 'description': "The Adolescents' Physical Activity Questionnaire (PAQ-A) in Arabic edition was used to measure the physical activity level assessment."}, {'measure': 'Physical activity level assessment', 'timeFrame': 'after 12 weeks', 'description': "The Adolescents' Physical Activity Questionnaire (PAQ-A) in Arabic edition was used to measure the physical activity level assessment."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemophilia', 'Knee Arthropathy']}, 'referencesModule': {'references': [{'pmid': '11851757', 'type': 'BACKGROUND', 'citation': 'Hilberg T, Herbsleb M, Gabriel HH, Jeschke D, Schramm W. Proprioception and isometric muscular strength in haemophilic subjects. Haemophilia. 2001 Nov;7(6):582-8. doi: 10.1046/j.1365-2516.2001.00563.x.'}, {'pmid': '10647529', 'type': 'BACKGROUND', 'citation': 'Falk B, Portal S, Tiktinsky R, Weinstein Y, Constantini N, Martinowitz U. Anaerobic power and muscle strength in young hemophilia patients. Med Sci Sports Exerc. 2000 Jan;32(1):52-7. doi: 10.1097/00005768-200001000-00009.'}, {'pmid': '26613579', 'type': 'RESULT', 'citation': 'Regaieg S, Charfi N, Yaich S, Damak J, Abid M. The Reliability and Concurrent Validity of a Modified Version of the International Physical Activity Questionnaire for Adolescents (IPAQ-A) in Tunisian Overweight and Obese Youths. Med Princ Pract. 2016;25(3):227-32. doi: 10.1159/000442752. Epub 2015 Nov 26.'}]}, 'descriptionModule': {'briefSummary': 'This study intended to examine the effect of a physical rehabilitation program incorporating Kinect-based virtual reality on gait characteristics, functional ability, and physical activity level in adolescents with hemophilic knee arthropathy.', 'detailedDescription': 'The usage of virtual reality in clinical practice as an alternative for conventional procedures has recently sparked the interest of health professionals. Virtual reality is a type of computer technology that provides simulated sensory feedback to allow children to participate in activities and events that are comparable to those they could face in real life. It can be used therapeutically to enhance strength, range of motion, coordination, mental concentration, problem solving, decision making, balance, and gait.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* moderate hemophilia\n* bilateral involvement of the knee joint\n* medically stable and received their factor replacement therapy\n* free from contracture or congenital anomalies\n* didn't have persisting, disabling pain.\n\nExclusion Criteria:\n\n* recent bleeding episodes\n* severe radiological abnormalities such as bone erosions, degeneration, bone ankylosis, or joint subluxation\n* engagement in a regular exercise program in the past six months\n* the unwillingness to stick to the training schedule"}, 'identificationModule': {'nctId': 'NCT05802368', 'acronym': 'hemophilia', 'briefTitle': 'Hemophilic Knee Arthropathy Virtual Reality', 'organization': {'class': 'OTHER', 'fullName': 'Qassim University'}, 'officialTitle': 'Adolescents With Hemophilic Knee Arthropathy Can Improve Their Gait Characteristics, Functional Ability, and Physical Activity Level Through Kinect-based Virtual Reality: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'RHPT/0021/0023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'a 30-minute VR-based training session utilizing Kinect Xbox after the session of traditional physical therapy.', 'interventionNames': ['Other: virtual reality group', 'Other: exercise group']}, {'type': 'EXPERIMENTAL', 'label': 'control group', 'description': 'Traditional physical therapy, 30-minutes physical therapy exercise program each week with 48-hour intervals at least', 'interventionNames': ['Other: exercise group']}], 'interventions': [{'name': 'virtual reality group', 'type': 'OTHER', 'otherNames': ['Kinect based virtual reality combined with physical exercises'], 'description': 'a 30-minute VR-based training session utilizing Kinect Xbox after the session of traditional physical therapy.', 'armGroupLabels': ['study group']}, {'name': 'exercise group', 'type': 'OTHER', 'otherNames': ['physical exercises alone'], 'description': 'Traditional physical therapy, 30-minutes physical therapy exercise program each week with 48-hour intervals at least', 'armGroupLabels': ['control group', 'study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Kharj', 'state': 'Riyadh Region', 'country': 'Saudi Arabia', 'facility': 'King Khalid Hospital', 'geoPoint': {'lat': 24.15541, 'lon': 47.33457}}], 'overallOfficials': [{'name': 'Alshimaa Azab, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prince Sattam Bin Abdulaziz University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '6 months after publication', 'ipdSharing': 'YES', 'description': 'The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.', 'accessCriteria': 'relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maged Basha', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}, {'name': 'Prince Sattam Bin Abdulaziz University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, College of Medical Rehabilitation, Qassim University', 'investigatorFullName': 'Maged Basha', 'investigatorAffiliation': 'Qassim University'}}}}