Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 3:04 AM
Study NCT ID:
NCT07476092
Status:
RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Digital-based Games on the Visual and Cognitive Performance of Young Children With Intellectual Disabilities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008607', 'term': 'Intellectual Disability'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-12', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in visual memory performance', 'timeFrame': 'Baseline, 3 months, 6 months, and 12 months', 'description': 'Visual memory performance will be assessed using the Benton Visual Retention Test (BVRT). The BVRT evaluates visual perception, visual memory, and visuoconstructive abilities by asking participants to identify previously presented geometric figures. Scores range from 0 to 15, with higher scores indicating better visual memory performance.'}, {'measure': 'Change in cognitive performance', 'timeFrame': 'Baseline, 3 months, 6 months, and 12 months after baseline.', 'description': 'Cognitive performance will be evaluated using the Standardized Mini Mental Test (SMMT). The SMMT assesses orientation, attention, memory, language, and visuospatial abilities. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intellectual Disability', 'Cognitive Performance', 'Visual Memory', 'Digital Intelligence Games', 'Randomized Controlled Trial', 'MentalUP'], 'conditions': ['Intellectual Disability']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial aims to evaluate the effect of digital intelligence games on visual and cognitive performance in young individuals with intellectual disabilities. Participants aged 18-35 years receiving services from EÇADEM in Istanbul will be randomly assigned to either an intervention group receiving digital intelligence game training using the MentalUP application or a control group receiving routine services. Visual memory and cognitive performance will be assessed using the Benton Visual Retention Test and the Standardized Mini Mental Test at baseline, 3 months, 6 months, and 12 months. The study will investigate the short- and long-term effects of digital cognitive training on visual and cognitive functioning.', 'detailedDescription': 'This study is designed as an experimental, parallel-group, repeated-measures randomized controlled trial. The study aims to examine the effects of digital intelligence games on the visual and cognitive performance of young individuals with intellectual disabilities.\n\nParticipants will be recruited from EÇADEM (Engelli Çocuklar Aile Destek Eğitim Merkezi) located in Sarıyer district of Istanbul. Participants meeting the inclusion criteria will be randomly assigned to intervention and control groups using stratified block randomization according to the level of intellectual disability (mild and moderate).\n\nThe intervention group will participate in structured digital intelligence game activities using the MentalUP platform, conducted twice weekly under the supervision of a clinical psychologist and an occupational therapist. The control group will receive routine services provided by the center without additional intervention.\n\nData will be collected at baseline and at 3-, 6-, and 12-month follow-ups using the Benton Visual Retention Test and the Standardized Mini Mental Test. The study will evaluate both short-term and long-term effects of the digital intervention.\n\nThe study protocol follows the CONSORT guidelines for randomized controlled trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals aged 18-35 years\n* Diagnosed with mild or moderate intellectual disability\n* Receiving services from EÇADEM\n* Ability to participate in cognitive activities\n* Written consent from parents/guardians\n* No visual or hearing impairment\n* No severe motor coordination problems\n\nExclusion Criteria:\n\n* Severe intellectual disability\n* Visual or hearing impairment\n* Any medical condition preventing participation\n* Lack of participant or parental consent'}, 'identificationModule': {'nctId': 'NCT07476092', 'briefTitle': 'Evaluation of the Effect of Digital-based Games on the Visual and Cognitive Performance of Young Children With Intellectual Disabilities', 'organization': {'class': 'OTHER', 'fullName': 'Koç University'}, 'officialTitle': 'Evaluation of the Effect of Digital-based Games on the Visual and Cognitive Performance of Young Children With Intellectual Disabilities: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2024.391.IRB2.173'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital Intelligence Game Intervention', 'description': 'Participants will receive digital intelligence game training using the MentalUP platform under supervision of a clinical psychologist and occupational therapist. Sessions will be conducted twice weekly and include structured cognitive exercises targeting attention, memory, and problem-solving skills.', 'interventionNames': ['Behavioral: MentalUP Digital Intelligence Game']}, {'type': 'NO_INTERVENTION', 'label': 'Routine Care', 'description': 'Participants will receive routine services provided by EÇADEM without additional digital cognitive training.'}], 'interventions': [{'name': 'MentalUP Digital Intelligence Game', 'type': 'BEHAVIORAL', 'description': 'MentalUP is a digital cognitive training platform designed to improve attention, memory, logical reasoning, and problem-solving abilities through adaptive intelligence games.', 'armGroupLabels': ['Digital Intelligence Game Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Türkiye', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Nihan Yurdadön, MSc.', 'role': 'CONTACT', 'email': 'nyurdadon@ku.edu.tr', 'phone': '+90 5074343362'}, {'name': 'İpek Bertan, MSc.', 'role': 'CONTACT', 'email': 'ibertan@ku.edu.tr', 'phone': '+90 5413300220'}, {'name': 'Nihan Yurdadön, MSc.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'EÇADEM', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Remziye Semerci-Şahin, Assistant professor', 'role': 'CONTACT', 'email': 'remziyesemerci@gmail.com', 'phone': '+90 5350112821'}, {'name': 'Enes Şimşek, MSc. PhD(c)', 'role': 'CONTACT', 'email': 'enessimsek19@ku.edu.tr', 'phone': '+90 5462502050'}], 'overallOfficials': [{'name': 'Remziye Semerci-Şahin, Assistant professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Koç University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to ethical considerations and the need to protect participant confidentiality.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Koç University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Semahat Arsel Nursing Education, Practice and Research Center (SANERC)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc. PhD(c)', 'investigatorFullName': 'Enes Simsek', 'investigatorAffiliation': 'Koç University'}}}}