Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 7:13 AM
Study NCT ID:
NCT06010134
Status:
UNKNOWN
Last Update Posted:
2023-08-24
First Post:
2023-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteogenesis Imperfecta and Balance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010013', 'term': 'Osteogenesis Imperfecta'}], 'ancestors': [{'id': 'D010009', 'term': 'Osteochondrodysplasias'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Double (Participant, Investigator) Single (Outcomes Assessor) Blinding process to participants and care providers was impossible due to the nature of intervention therapy. Data were analyzed by an impartial statistician (outcomes assessor), referring to each arm with an encoded name: Group 1 (control group) and Group 2 (Whole Body Vibration group).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'G 1 (control) received traditional physical therapy program for 30 min. G 2 (study) received traditional physical therapy program for 15 min. and Whole Body Vibration for 15 min'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-17', 'studyFirstSubmitDate': '2023-08-17', 'studyFirstSubmitQcDate': '2023-08-17', 'lastUpdatePostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Over All Stabiity Index', 'timeFrame': 'at day 0', 'description': 'Stability Index'}, {'measure': 'Over All Stabiity Index', 'timeFrame': 'at day 90', 'description': 'Stability Index'}, {'measure': 'Medio lateral Stabiity Index', 'timeFrame': 'at day 0', 'description': 'Stability Index'}, {'measure': 'Medio lateral Stabiity Index', 'timeFrame': 'at day 90', 'description': 'Stability Index'}, {'measure': 'Antro posterior Stabiity Index', 'timeFrame': 'at day 0', 'description': 'Stabiity Index'}, {'measure': 'Antro posterior Stabiity Index', 'timeFrame': 'at day 90', 'description': 'Stabiity Index'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteogenesis Imperfecta', 'Whole Body Vibration', 'Balance', 'Motor Control'], 'conditions': ['Osteogenesis Imperfecta']}, 'referencesModule': {'references': [{'pmid': '2805382', 'type': 'RESULT', 'citation': 'Andersen PE Jr, Hauge M. Osteogenesis imperfecta: a genetic, radiological, and epidemiological study. Clin Genet. 1989 Oct;36(4):250-5. doi: 10.1111/j.1399-0004.1989.tb03198.x.'}, {'pmid': '27448250', 'type': 'RESULT', 'citation': 'Folkestad L, Hald JD, Ersboll AK, Gram J, Hermann AP, Langdahl B, Abrahamsen B, Brixen K. Fracture Rates and Fracture Sites in Patients With Osteogenesis Imperfecta: A Nationwide Register-Based Cohort Study. J Bone Miner Res. 2017 Jan;32(1):125-134. doi: 10.1002/jbmr.2920. Epub 2016 Aug 29.'}, {'pmid': '26987995', 'type': 'RESULT', 'citation': 'Bishop N. Bone Material Properties in Osteogenesis Imperfecta. J Bone Miner Res. 2016 Apr;31(4):699-708. doi: 10.1002/jbmr.2835. Epub 2016 Mar 26.'}, {'pmid': '10831929', 'type': 'RESULT', 'citation': 'Rauch F, Travers R, Parfitt AM, Glorieux FH. Static and dynamic bone histomorphometry in children with osteogenesis imperfecta. Bone. 2000 Jun;26(6):581-9. doi: 10.1016/s8756-3282(00)00269-6.'}]}, 'descriptionModule': {'briefSummary': 'Osteogenesis Imperfecta (OI), also known as brittle bone disease, is a group of genetic disorders that mainly affect the bones. It results in bones that break easily. Its severity may be mild to severe. Other symptoms may include a blue tinge to the whites of the eye, short height, loose joints, hearing loss, breathing problems and problems with the teeth.\n\nPhysiotherapy is aimed to strengthen muscles and improve motility in a gentle manner, while minimizing the risk of fracture, and the use of support cushions to improve posture.', 'detailedDescription': 'This study aimed to assess the efficacy of Whole Body Vibration on balance and motor function in children with Osteogenesis Imperfecta.\n\nWhole body vibration (WBV) therapy is targeted at musculoskeletal strengthening and has been trialed in a variety of conditions. WBV has been shown to have therapeutic advantage in various osteopenic preclinical models and populations such as postmenopausal women (improved mobility, muscle strength, postural strength, and bone density) and children with osteogenesis imperfecta (improved mobility)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Their age was ranging from six to twelve years\n2. Children participated in this study were from both sexes\n3. All children with stable medical and psychological status.\n4. They were able to follow the verbal commands or instructions during testing.\n\nExclusion Criteria:\n\n1. Children with visual or auditory problems.\n2. Children with any cognitive problems.\n3. Children without deformity'}, 'identificationModule': {'nctId': 'NCT06010134', 'briefTitle': 'Osteogenesis Imperfecta and Balance', 'organization': {'class': 'OTHER', 'fullName': 'South Valley University'}, 'officialTitle': 'Efficacy of Whole Body Vibration on Balance and Motor Control in Children With Osteogenesis Imperfecta', 'orgStudyIdInfo': {'id': 'P.T.REC/012/002577'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control Group', 'description': 'Group 1 the control group received selected physical therapy program which contain strengthening exercises for upper limb and lower limb muscles, stretching exercises for elbow extensors, hand pronator, wrist extensors, knee extensors and ankle dorsiflexors, coordination and balancing exercises.', 'interventionNames': ['Other: Physical Therapy Program']}, {'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Group 2 the study group received the same physical therapy program 15 min. plus Whole Body Vibration for 15 min.', 'interventionNames': ['Other: Physical Therapy Program']}], 'interventions': [{'name': 'Physical Therapy Program', 'type': 'OTHER', 'description': 'Physical Therapy Program plus Whole Body Vibration', 'armGroupLabels': ['Control Group', 'Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83523', 'city': 'Qina', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'South Valley University, Faculty of Physical Therapy', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}], 'centralContacts': [{'name': 'Nehad Abo-zaid, Assistant Professor', 'role': 'CONTACT', 'email': 'dr.nehadahmed@svu.edu.eg', 'phone': '+201008980727'}], 'overallOfficials': [{'name': 'Hanady Mohamed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Physical Therapy, Benha University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Valley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatric Physical Therapy', 'investigatorFullName': 'Nehad Ahmed Youness Abo-zaid', 'investigatorAffiliation': 'South Valley University'}}}}