Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT05749718
Status:
UNKNOWN
Last Update Posted:
2023-09-13
First Post:
2023-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reliability and Validity of the Turkish Version of the Object Permanence Scale
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007859', 'term': 'Learning Disabilities'}], 'ancestors': [{'id': 'D003147', 'term': 'Communication Disorders'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-11', 'studyFirstSubmitDate': '2023-02-19', 'studyFirstSubmitQcDate': '2023-02-19', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Object Permanence Scale', 'timeFrame': 'Baseline', 'description': 'The minimum score of the Object Permanence Scale is 0, and the maximum score is 10. Higher scores indicate better outcome.'}, {'measure': 'Object Permanence Scale', 'timeFrame': 'After 1 week (retest)', 'description': 'The minimum score of the Object Permanence Scale is 0, and the maximum score is 10. Higher scores indicate better outcome.'}, {'measure': 'The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) motor and cognitive subscales', 'timeFrame': 'Baseline', 'description': 'Cognitive subscale consists of 91 items and Motor subscale consists of 138 items. Items are scored as 1 (done) and 0 (not able to). Higher scores indicate better outcome.'}, {'measure': 'Gross motor function measure sitting subscale', 'timeFrame': 'Baseline', 'description': 'The sitting subscale consists of 20 items. Each item is scored on a 4-point ordinal scale (0-3). Higher scores indicate better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Developmental Delay']}, 'descriptionModule': {'briefSummary': 'The aim of the study is the cultural adaptation of the Object Permanence Scale to Turkish and to examine its validity and reliability. The sample of the study will be 7-16 months old babies with motor developmental delay. Inclusion criteria: 7-16 months of age, sitting for at least 3 seconds but not being able to switch independently between sitting and other positions, and showing at least one developmental delay in the motor development subscale of the Bayley III Developmental Assessment. Evaluations will be done at baseline and after 1 week (retest). Exclusion criteria: Medical complications (eg, severe visual impairment) limiting participation in assessments; autism, down syndrome, or spinal cord injury; diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Months', 'minimumAge': '7 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infants aged 7-16 months with motor developmental delay', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 7-16 months,\n* Sitting for at least 3 seconds but unable to independently switch between sitting and other positions\n* To show at least one retardation in motor subscale of Bayley III.\n\nExclusion Criteria:\n\n* Medical complications (eg, severe visual impairment) limiting participation in assessments; autism, down syndrome, or spinal cord injury; diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder'}, 'identificationModule': {'nctId': 'NCT05749718', 'briefTitle': 'Reliability and Validity of the Turkish Version of the Object Permanence Scale', 'organization': {'class': 'OTHER', 'fullName': 'Tokat Gaziosmanpasa University'}, 'officialTitle': 'Reliability and Validity of the Turkish Version of the Object Permanence Scale', 'orgStudyIdInfo': {'id': 'GaziosmanpasaU_Erol_02'}}, 'contactsLocationsModule': {'locations': [{'zip': '60250', 'city': 'Tokat Province', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Erkan Erol, PhD', 'role': 'CONTACT', 'email': 'erkanerol@gmail.com', 'phone': '05547920118'}], 'facility': 'Faculty of Health Sciences, Tokat Gaziosmanpaşa University', 'geoPoint': {'lat': 40.31389, 'lon': 36.55444}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tokat Gaziosmanpasa University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Erkan Erol', 'investigatorAffiliation': 'Tokat Gaziosmanpasa University'}}}}