Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT06036069
Status:
UNKNOWN
Last Update Posted:
2023-10-13
First Post:
2023-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Whole Body Vibration Versus Core Stability Exercises on Balance and Muscle Strength in Children With Down Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004314', 'term': 'Down Syndrome'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Single (outcomes Assessor)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized control study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-01-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-11', 'studyFirstSubmitDate': '2023-09-02', 'studyFirstSubmitQcDate': '2023-09-11', 'lastUpdatePostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biodex Balance System', 'timeFrame': 'before intervention and after 12 weeks of intervention', 'description': 'it is a reliable and objective assessment in order to quantify dynamic balance'}], 'secondaryOutcomes': [{'measure': 'Hand-held dynamometer', 'timeFrame': 'before intervention and after 12 weeks of intervention', 'description': 'It is a portable device (Nicholas Manual Muscle Tester, Model 01160; Lafayette Instrument, Lafayette, IN), characterized as low-cost and convenient method'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Children; Core Stability Exercises; Down Syndrome; Whole Body Vibration'], 'conditions': ['Down Syndrome']}, 'descriptionModule': {'briefSummary': 'Children had Down syndrome often have impaired balance and postural control and result as less active than their peers that can lead to reduced quality of life and movement skills. Effects of physical activity may be important in preventing falling risk and health consequences in those children', 'detailedDescription': 'Sixty children from both genders (boys and girls) participated in this study, their ages ranged from 10 to 16 years and they were randomized into three groups of same number (A, B and C). Groups (A) received conventional physical therapy program, group (B) received the same conventional physical therapy program of group (A) and core stability exercises while group (C) received the same conventional physical therapy program of group (A and B) and whole body vibration exercise'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 10 to 16 years.\n* Able to recognize commands given to them.\n* Understand our verbal command and encouragement.\n* Stand and walk independently without repeated falling.\n\nExclusion Criteria:\n\n* Children with any neurological (signs of epilepsy and instability of atlantoaxial joint).\n* Musculoskeletal, or mobility disorders.\n* Cardiac anomalies.\n* Vision or hearing loss.'}, 'identificationModule': {'nctId': 'NCT06036069', 'briefTitle': 'Effect of Whole Body Vibration Versus Core Stability Exercises on Balance and Muscle Strength in Children With Down Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'South Valley University'}, 'officialTitle': 'Improvement of Whole Body Vibration and Core Stability Exercises on Muscle Strength in Down Syndrome Children', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004335'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conventional physical therapy group', 'description': 'It consisted of 20 children received conventional physical therapy', 'interventionNames': ['Other: Conventional physical therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Core stability exercises group', 'description': 'It consisted of 20 children received conventional physical therapy and core stability exercises', 'interventionNames': ['Other: Conventional physical therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Whole body vibration', 'description': 'It consisted of 20 children received conventional physical therapy and whole body vibration exercises', 'interventionNames': ['Other: Conventional physical therapy']}], 'interventions': [{'name': 'Conventional physical therapy', 'type': 'OTHER', 'otherNames': ['Physical therapy program'], 'description': '* Standing with feet together while the therapist was sitting behind and manually locking the child knees.\n* Step standing with the therapist behind the child.\n* High step standing and trying to keep balanced. The child stood on exercise mattress.\n* Single leg stance "unilateral standing" with assistance. The child was standing on exercise mattress.\n* Standing on a declined surface by using wedge. The child was standing on wedge towards the descending direction.\n* Standing with manual locking of the knees.\n* Changing position.\n* Gait training.\n* Static and dynamic muscle contraction.', 'armGroupLabels': ['Conventional physical therapy group', 'Core stability exercises group', 'Whole body vibration']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'state': 'Faisal', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ragaee Mahmoud', 'role': 'CONTACT', 'email': 'ragaeesaeedpt10@gmail.com', 'phone': '00201223611112'}, {'name': 'Reham Mahmoud', 'role': 'CONTACT', 'email': 'rsm_211pt@yahoo.com', 'phone': '00201015447798'}], 'facility': 'Ragaee Saeed Mahmoud', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ragaee Saeed Mahmoud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Ragaee Saeed Mahmoud', 'investigatorAffiliation': 'South Valley University'}}}}