Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT05849818
Status:
UNKNOWN
Last Update Posted:
2023-05-09
First Post:
2023-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Virtual Reality Technology For Cognitive Functions Of 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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective Randomized controlled trial of pre-post study design with a two months follow up evaluation will be used'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-28', 'studyFirstSubmitDate': '2023-04-14', 'studyFirstSubmitQcDate': '2023-04-28', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of change of cognitive function by using the rehacom device', 'timeFrame': 'up to two months', 'description': 'Assessing the change of the cognitive function By using the Rehacom Device within two months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Down syndrome DS', 'Virtual Reality VR'], 'conditions': ['Down Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to identify the effect of fully-immersive virtual reality technology on cognitive functions of children with Down syndrome', 'detailedDescription': 'Intellectual disability is recognized as one of the most prominent features of DS which is the most common genetic cause of intellectual disability. Cognitive functioning often changes across the lifespan and is moderated by several comorbid factors such as sensory impairments, seizures, autism, sleep disruption, and other medical and psychiatric conditions (Grieco et al., 2015).\n\nThere is encouraging evidence supporting the use of non-immersive virtual environments to provide useful learning, rehabilitation, and leisure experiences for people with intellectual disabilities. Therefore, immersive VR applications may also be an effective way to improve motivation and engagement for children with DS in learning settings (Michalski et al., 2022). Therefore, this study aims to investigate the effect of full-immersive VRapeutic software gaming technology on cognitive functions of children with Down syndrome'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with Down Syndrome Age from 6-10 years Both Genders will be included IQ Ranges from 50-69(mild intellectual disability) they will be able to understand the instructions able to walk independently\n\nExclusion Criteria:\n\n* Significant Visual or Hearing problems Significant mental or psychological problems that interfere with understanding instructions musculoskeletal problems or fixed deformities in upper or lower limbs Current hospitalization for urgent Medical reasons'}, 'identificationModule': {'nctId': 'NCT05849818', 'briefTitle': 'Virtual Reality Technology For Cognitive Functions Of Children With Down Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Virtual Reality Technology For Cognitive Functions Of Children With Down Syndrome', 'orgStudyIdInfo': {'id': 'Ayman Kamal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Effect of fully immersive VR + school regular activities on cognitive functions of Down children', 'description': 'Children in this group will practice the same activities as control group in addition to virtual reality session using fully-immersive VRapeutic software gaming technology (Viblio module)for 20 min/3sessions/week for 8 weeks.', 'interventionNames': ['Device: full-immersive VRapeutic software gaming technology']}, {'type': 'NO_INTERVENTION', 'label': 'Effect of school regular activities on cognitive functions of down children', 'description': 'Children in this group will practice their regular activities of school and daily living (receive no treatment).'}], 'interventions': [{'name': 'full-immersive VRapeutic software gaming technology', 'type': 'DEVICE', 'otherNames': ['VRapeutic software gaming technology'], 'description': '* Children of the study group will receive VR training sessions 3 times per week for 8 successive weeks.\n* Viblio VRapeutic fully immersive game will be used.\n* Manual instructions of the game will be followed and features of the game will be customized.\n* The child instructed to put back a pile of books on the floor into their shelves.\n* Level II of the game we will use audio visual distractors , repeated parrot sound and the child is required to order the books by colors\n* Level III distracting tasks during book ordering\n* The complexity of the game depend on task duration, number of books and the nature of distractors', 'armGroupLabels': ['Effect of fully immersive VR + school regular activities on cognitive functions of Down children']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12511', 'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Amira Eltohamy, Professor', 'role': 'CONTACT', 'phone': '00201001662350'}, {'name': 'maya galal, lecturer', 'role': 'CONTACT', 'email': 'maya.galal@pt.cu.edu.eg', 'phone': '00201002631238'}], 'overallOfficials': [{'name': 'Amira Eltohamy, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatric physical therapy', 'investigatorFullName': 'Ayman Kamal Elboraey', 'investigatorAffiliation': 'Cairo University'}}}}