Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-02-21 @ 6:45 PM
Study NCT ID:
NCT03029312
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2017-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Whole Body Vibration Training in Children With Osteogenesis Imperfecta and Limited Mobility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010013', 'term': 'Osteogenesis Imperfecta'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Paired randomized controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-23', 'studyFirstSubmitDate': '2017-01-19', 'studyFirstSubmitQcDate': '2017-01-23', 'lastUpdatePostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Does WBVT increase bone density at the distal tibia', 'timeFrame': '5 months', 'description': 'Trabecular volumetric BMD measured at the distal tibia (4% of tibia length)'}], 'secondaryOutcomes': [{'measure': 'Does WBVT result in an increase in dynamic muscle function', 'timeFrame': '5 months', 'description': 'Jumping Mechanography (single 2-leg jump, multiple one leg hop, chair and heel rise test)'}, {'measure': 'Does WBVT result in an increase in muscle mass', 'timeFrame': '5 months', 'description': 'Muscle mass measured by DXA'}, {'measure': 'Does WBVT result in an increase in density', 'timeFrame': '5 months', 'description': 'Bone density measured by DXA'}, {'measure': 'Does WBVT result in an increase in density of the tibia', 'timeFrame': '5 months', 'description': 'Bone density measured by pQCT'}, {'measure': 'Does WBVT result in an increase in bone geometry', 'timeFrame': '5 months', 'description': 'Bone size measured by pQCT'}, {'measure': 'Does WBVT result in an increase in 6-minute walking distance', 'timeFrame': '5 months', 'description': 'six minute walk tests'}, {'measure': 'Does WBVT result in improved disability', 'timeFrame': '5 months', 'description': 'CHAQ disability score'}, {'measure': 'Does WBVT result in improved balance', 'timeFrame': '5 months', 'description': 'Balance (sway area measured by mechanography)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'keywords': ['whole body vibration', 'Muscle function', 'Physical activity', 'bone density'], 'conditions': ['Osteogenesis Imperfecta']}, 'referencesModule': {'references': [{'pmid': '28472303', 'type': 'DERIVED', 'citation': 'Hogler W, Scott J, Bishop N, Arundel P, Nightingale P, Mughal MZ, Padidela R, Shaw N, Crabtree N. The Effect of Whole Body Vibration Training on Bone and Muscle Function in Children With Osteogenesis Imperfecta. J Clin Endocrinol Metab. 2017 Aug 1;102(8):2734-2743. doi: 10.1210/jc.2017-00275.'}]}, 'descriptionModule': {'briefSummary': 'Children with osteogenesis imperfecta (OI) have impaired bone strength, fractures, weak muscles and limited mobility. Mild to moderate forms of OI (type 1 and 4) may benefit from muscle training that leads to secondary improvement in bone strength (osteogenic treatment). Recent studies in children with cerebral palsy but also OI suggest that Whole Body Vibration Training (WBVT) improves mobility and also bone strength. No randomized controlled trials exist in OI children. This randomized controlled pilot study assesses the effect of 5 months WBVT (2 x 9min/day) on muscle function, mobility, bone structure and density. 24 children \\>5 years with OI type 1 and 4 with limited mobility (CHAQ Score ≥0.13) will be randomized into a WBVT group and a control group matched by gender and pubertal stage. Main outcome measure is the change in tibial volumetric BMD, secondary outcomes include a variety of bone, mobility and dynamic muscle function variables.', 'detailedDescription': "Osteogenesis imperfecta (OI) is a bone fragility disorder with impaired bone strength, fractures, weak muscles and limited mobility. Mild to moderate forms of OI (type 1 and 4) may not require bisphosphonate therapy but would benefit from muscle training that leads to secondary improvement in bone strength (osteogenic treatment). The mechanostat theory states that bone adapts its strength to mechanical forces mostly imposed by muscle. According to this widely accepted theory, any treatment that strengthens muscle should also strengthen bones. Whole body vibration therapy (WBVT) with side-alternating platforms (Galileo™) uses the body's neuromotor reflex system to train muscles. Recent studies in children with cerebral palsy but also OI suggest that WBVT improves mobility and also bone strength. No randomized controlled trials exist in OI children.\n\nThis randomized controlled study assesses the effect of 5 months whole body vibration training (2 x 9min/day) on muscle strength, motor function, bone structure and density. 24 children \\>5 years with OI type 1 and 4 with limited mobility (CHAQ Score ≥0.13) will be randomized into a WBVT group and a control group matched by gender and pubertal stage. Children with OI will be recruited from specialist clinics in Birmingham, Manchester and Sheffield, as well as via advertisement on the Brittle Bone Society's homepage. Patients will be equipped with side-alternating vibration platforms for home use and train with increasing intensity. Outcome measures are tested pre- and post 5-months intervention. Dynamic muscle function is measured by mechanography (jumping force plates) and mobility by CHAQ questionnaire and a six-minute walk test. Changes in bone structure and density are assessed by DXA and peripheral QCT of the tibia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '5 Years', 'genderBased': True, 'genderDescription': '12 boys, 12 girls', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with mild OI (type 1 and 4; \\>5y of age) who need to be at least partly ambulant and have a CHAQ score of greater than 0.13, constituting at least mild disability. Minimum requirement is the ability to rise from a chair.\n\nInformed consent is required from the participant and/or parent/guardian.\n\n\\-\n\nExclusion Criteria:\n\n* On bisphosphonate treatment for less than 2years (since mobility usually improves during the initial phase treatment).\n* Finished bisphosphonate therapy less than 6 months ago\n* Recent lower limb fracture \\<3months ago, or upper limb fracture which is still in plaster.\n* Heart or lung disease, use of steroids (oral, systemic, topical or inhaled, for more than 3 weeks in the last 12 months) or any other bone-active treatment.'}, 'identificationModule': {'nctId': 'NCT03029312', 'briefTitle': 'Whole Body Vibration Training in Children With Osteogenesis Imperfecta and Limited Mobility', 'organization': {'class': 'OTHER', 'fullName': "Birmingham Women's and Children's NHS Foundation Trust"}, 'officialTitle': 'Whole Body Vibration as an Osteogenic Treatment for Children With Osteogenesis Imperfecta With Limited Mobility: A Randomised Controlled Pilot Trial', 'orgStudyIdInfo': {'id': '11/WM/0275'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Whole Body Vibration', 'description': "Twice daily WBVT at home using the Galileo M device, 3x3 min, with 3 minute breaks (total daily WBVT 18 min) for 5 months. Children stand upright on the device, with knees bent (10-45 degrees, semi-squat or squat position). A schedule of increasing intensity of vibration exercise was used over time, allowing some adjustment to the patient's physical capability. Amplitude 1 was used for the first 2 weeks, then increased to amplitude 2 and further increased up to amplitude 3, if individually possible, always using frequencies between 20-25Hz. Children also perform exercises on the platform, including shifting their weight from one side to the other, increase/decrease their knee and hip angle, weight shift with trunk rotation, and alternate flexion and extension of knees.", 'interventionNames': ['Device: Galileo M']}, {'type': 'NO_INTERVENTION', 'label': 'Regular Care', 'description': 'Regular Care, including physiotherapy for 5 months'}], 'interventions': [{'name': 'Galileo M', 'type': 'DEVICE', 'otherNames': ['Vibraflex'], 'description': 'Motorized board producing side-to-side alternating vertical sinusoidal (rotational) vibrations around a fulcrum in the mid-section of the plate. The vibration frequency can be selected by the user who stands on the board with both feet, wearing shoes. The peak-to-peak displacement to which the feet are exposed increases with the distance of the feet from the centre line of the vibrating board. Three positions marked 1, 2 and 3 are indicated on the vibrating board, corresponding to peak-to-peak displacements of 2, 4, and 6mm. The peak acceleration exerted by vibration exercise increases with higher frequencies and higher amplitudes.', 'armGroupLabels': ['Whole Body Vibration']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B46NH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': "Birmingham Children's Hospital", 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}], 'overallOfficials': [{'name': 'Wolfgang Högler, MD PD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Birmingham Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Anonymised data available on request, subject to Ethical and R\\&D guidelines'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Birmingham Women's and Children's NHS Foundation Trust", 'class': 'OTHER'}, 'collaborators': [{'name': "Royal Manchester Children' s Hospital, Manchester", 'class': 'UNKNOWN'}, {'name': 'University of Sheffield', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}