Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-28 @ 7:03 AM
Study NCT ID:
NCT06197750
Status:
COMPLETED
Last Update Posted:
2024-01-09
First Post:
2023-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Vestibular Stimulation on Motor Proficiency and Balance Among Children With Down Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015837', 'term': 'Vestibular Diseases'}, {'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-26', 'studyFirstSubmitDate': '2023-02-05', 'studyFirstSubmitQcDate': '2023-12-26', 'lastUpdatePostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Berg Balance Scale', 'timeFrame': '16 WEEKS', 'description': 'Improvement in balance from baseline among children with Down syndrome'}, {'measure': 'motor proficiency', 'timeFrame': '16 WEEKS', 'description': 'Improvement in motor proficiency from baseline among children with Down syndrome'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vestibular stimulation (VeS)', 'Hypotonic cerebral palsy'], 'conditions': ['Vestibular System Disorder']}, 'descriptionModule': {'briefSummary': 'This was a randomized controlled trial study where there the total participants were 22and these participants were randomly selected and then distributed in to two groups all participants were selected according to the inclusion exclusion criteria of the study and then they were randomly distributed in two groups named as group A and group B both of the contain equal number of participants which are randomly distributed in groups each group contain 11 participants .Group A received the vestibular stimulation by swing in different positions supine, prone and with or without support in each position for 10minnts 3 times a week for 10 weeks along with general strengthening exercises of upper and lower limb and group B will receive general strengthening exercises of whole body for same time period. Data will be then analyzed by using SPSS windows version 25', 'detailedDescription': 'This was a randomized controlled trial study where there the total participants were 22and these participants were randomly selected and then distributed in to two groups all participants were selected according to the inclusion exclusion criteria of the study and then they were randomly distributed in two groups named as group A and group B both of the contain equal number of participants which are randomly distributed in groups each group contain 11 participants .Group A received the vestibular stimulation by swing in different positions supine, prone and with or without support in each position for 10minnts 3 times a week for 10 weeks along with general strengthening exercises of upper and lower limb and group B will receive general strengthening exercises of whole body for same time period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:• Down syndrome\n\n* Age 6 to 11 years\n* Having no other medical history (6)\n\nExclusion Criteria:\n\n* • Visual impairment\n\n * Patient with hearing impairment\n * Patient with poor cognition (6, 8)'}, 'identificationModule': {'nctId': 'NCT06197750', 'briefTitle': 'Effect of Vestibular Stimulation on Motor Proficiency and Balance Among Children With Down Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effect of Vestibular Stimulation on Motor Proficiency and Balance Among Children With Down Syndrome', 'orgStudyIdInfo': {'id': 'REC/RCR&AHS/22/0745'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vestibular stimulation', 'description': 'Group A received the vestibular stimulation by swing in different positions supine, prone and with or without support in each position for 10minnts 3 times a week for 10 weeks along with general strengthening exercises of upper and lower limb and', 'interventionNames': ['Other: Vestibular stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'general strengthening exercises', 'description': 'group B will receive general strengthening exercises of whole body for same time period.', 'interventionNames': ['Other: General strengthening exercises']}], 'interventions': [{'name': 'Vestibular stimulation', 'type': 'OTHER', 'description': 'Vestibular stimulation by swing', 'armGroupLabels': ['Vestibular stimulation']}, {'name': 'General strengthening exercises', 'type': 'OTHER', 'description': 'General strengthening exercises', 'armGroupLabels': ['general strengthening exercises']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51480', 'city': 'Sialkot', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Rabia Razzaq', 'geoPoint': {'lat': 32.49268, 'lon': 74.53134}}], 'overallOfficials': [{'name': 'Fareeha Kausar, PP-DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}