Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-28 @ 5:44 AM
Study NCT ID:
NCT06094335
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2023-10-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Virtual Reality on Balance in Autism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Study and control groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-20', 'studyFirstSubmitDate': '2023-10-14', 'studyFirstSubmitQcDate': '2023-10-18', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Static Balance', 'timeFrame': '12 weeks', 'description': 'Change of overall postural sway scores using Biodex balance system'}, {'measure': 'Functional Balance', 'timeFrame': '12 weeks', 'description': 'Change in balance scores was measured using a pediatric balance scale. PBS collect scores for the 14 tasks assessed. The tasks are scored on a five-point scale (0, 1, 2, 3, or 4), with zero denoting an inability to perform the activity without assistance and four denoting the ability to perform the task with complete independence. Scores range from 0 to 56, with higher scores indicating better postural control'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['autism spectrum disorder', 'Biodex', 'Postural Control', 'Virtual Reality'], 'conditions': ['Autism']}, 'descriptionModule': {'briefSummary': 'Children with ASD have poorer postural balance when compared to normal individuals. So, The aim of this study is to assess the effect of Virtual Reality on postural control in Autistic children', 'detailedDescription': "Autism spectrum disorders are a collection of persistent neurodevelopmental disorders characterized by difficulties in social interactions, communication, and repetitive, stereotyped, and restricting behaviors. Movement problems can occur throughout infancy and are one of the early indications of autism. Furthermore, movement impairments are the most often observed nonverbal deficits in autistic children.\n\nPostural stability is described as the capacity to maintain an upright posture by keeping the body's center of gravity over its base of support with little swaying or maximal steadiness, and it is considered a fundamental skill required for normal motor development.\n\nVirtual Reality has been used in the field of balance rehabilitation and training because of its relatively low cost and enjoyment. Therefore, the purpose of this study was to study the effect of VR on balance in children with ASD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mild ASD\n\nExclusion Criteria:\n\n* Taking medication affect motor\n* Had a head injury, genetic disorder, blindness, fracture'}, 'identificationModule': {'nctId': 'NCT06094335', 'briefTitle': 'Effect of Virtual Reality on Balance in Autism', 'organization': {'class': 'OTHER', 'fullName': 'Batterjee Medical College'}, 'officialTitle': 'Influence of Virtual Reality Rehabilitation Training on Posture Control in Children With Autism Spectrum Disorders', 'orgStudyIdInfo': {'id': 'VRR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study', 'description': 'Virtual reality plus traditional physical therapy', 'interventionNames': ['Device: Virtual reality rehabilitation', 'Other: Traditional physical therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Traditional physical therapy', 'interventionNames': ['Other: Traditional physical therapy']}], 'interventions': [{'name': 'Virtual reality rehabilitation', 'type': 'DEVICE', 'description': 'Children in this group received Virtual Reality Rehabilitation plus traditional physical therapy', 'armGroupLabels': ['Study']}, {'name': 'Traditional physical therapy', 'type': 'OTHER', 'description': 'Flexibility exercises, strengthening exercises, endurance exercises, and postural stability exercises', 'armGroupLabels': ['Control', 'Study']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jeddah', 'country': 'Saudi Arabia', 'facility': 'Local Autism Center', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}], 'overallOfficials': [{'name': 'Mohamed A Abdel Ghafar, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Batterjee Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Batterjee Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of physical therapy', 'investigatorFullName': 'Mohamed A. Abdel Ghafar', 'investigatorAffiliation': 'Batterjee Medical College'}}}}