Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:17 AM
Study NCT ID:
NCT07366957
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-29
First Post:
2026-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motor Competence and Physical Activity in Children Aged 4-6: Associations With Parental Perceptions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2026-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-04-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-27', 'studyFirstSubmitDate': '2026-01-16', 'studyFirstSubmitQcDate': '2026-01-16', 'lastUpdatePostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor Development Scores (PDMS-II)', 'timeFrame': '12/2025-04/2026', 'description': "Children's gross and fine motor skills will be assessed using the Peabody Developmental Motor Scales - Second Edition (PDMS-II). The PDMS-II consists of gross motor and fine motor subtests and yields standard scores and composite scores.\n\nRaw scores are converted to standard scores, with a possible score range of 1 to 20 for subtests, and composite motor quotients ranging from 35 to 165.\n\nHigher scores indicate better motor performance and more advanced motor development.\n\nThis measure provides objective and standardized data on motor development in children aged 4-6 years."}], 'secondaryOutcomes': [{'measure': 'Parental Perception Scores', 'timeFrame': '12/2025-04/2026', 'description': "Parents' perceptions and attitudes regarding their children's motor skills and participation in physical activity will be explored using semi-structured interviews.\n\nThis outcome measure is qualitative in nature and does not involve a standardized scale or numerical scoring system.\n\nInterview data will be analyzed using thematic qualitative analysis to identify key themes related to parental understanding, perceptions, and support."}, {'measure': 'Parent-Child Motor Skill Concordance', 'timeFrame': '12/2025-04/2026', 'description': "The relationship between parental perceptions and children's actual PDMS-II motor scores will be examined using correlation analyses to explore discrepancies or alignments."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Motor competence', 'Motor development', 'Physical activity', 'Preschool children', 'Parental perceptions', 'Qualitative research'], 'conditions': ['Motor Development', 'Physical Activity']}, 'descriptionModule': {'briefSummary': "This study aims to determine motor competence and physical activity levels in children aged 4-6 years and to explore their relationship with parental perceptions. The study will use a qualitative research approach supported by quantitative assessments. Children's motor competence will be evaluated using the Peabody Developmental Motor Scales-Second Edition (PDMS-II), while parents will participate in semi-structured interviews to explore their perceptions, attitudes, and experiences related to their children's motor development and physical activity. Data will be collected in educational settings without any intervention. The findings are expected to contribute to a better understanding of family-related factors influencing motor development in early childhood.", 'detailedDescription': "This observational study aims to examine motor competence and physical activity levels in children aged 4-6 years and to explore their relationship with parental perceptions. Early childhood is a critical period for motor development, during which family-related factors may influence children's physical activity participation and motor skill acquisition.\n\nThe study will be conducted using a qualitative-dominant mixed-methods design with an embedded quantitative component. Children's motor competence will be assessed using the Peabody Developmental Motor Scales-Second Edition (PDMS-II), a standardized and validated tool for evaluating gross and fine motor skills in young children. Quantitative motor assessment data will be used to support and contextualize qualitative findings.\n\nParental perceptions will be explored through semi-structured interviews conducted separately with mothers and fathers. Interviews will focus on parents' views regarding their children's motor abilities, physical activity participation, and factors influencing these behaviors. Interviews will be conducted face-to-face, audio-recorded with participant consent, and transcribed verbatim for analysis.\n\nThe study will be carried out in educational settings in Bursa and Afyonkarahisar provinces. Participation will be voluntary, and written informed consent will be obtained from all parents prior to data collection. No interventions or experimental procedures will be applied during the study.\n\nQuantitative data will be analyzed descriptively, while qualitative data will be analyzed using thematic analysis to identify key themes related to parental perceptions. Integration of quantitative and qualitative findings is expected to provide a comprehensive understanding of the relationship between motor competence, physical activity, and family perceptions in early childhood. The results may inform family-centered approaches in child health, education, and rehabilitation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study population consists of children aged 4-6 years who were born at term (≥37 weeks of gestation) and do not have any physician-diagnosed neurological, physical, or developmental conditions, along with their parents who serve as the primary caregivers. The study includes children who are able to independently perform the motor assessment tests and parents who voluntarily agree to participate, provide written informed consent, and are able to communicate in Turkish.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren\n\n* Children aged 4-6 years based on chronological age,\n* Children without any physician-diagnosed physical, intellectual, or neurological disorders,\n* Children born at term (≥37 weeks of gestation),\n* Children with no history of serious perinatal or postnatal complications (e.g., prolonged neonatal intensive care unit stay, intracranial hemorrhage, requirement for advanced respiratory support),\n* Children able to independently complete the motor assessment tests used in the study.\n\nParents\n\n* Parents who voluntarily agree to participate in the study and provide written informed consent,\n* Parents with sufficient proficiency in reading, understanding, and expressing -themselves in Turkish,\n* Parents who are the primary caregivers of the child included in the study.\n\nExclusion Criteria:\n\nChildren\n\n* Children younger than 4 years or older than 6 years,\n* Children with a history of preterm birth (\\<37 weeks of gestation),\n* Children with any physician-diagnosed neurological, physical, developmental, or chronic conditions (e.g., cerebral palsy, pervasive developmental disorders, genetic syndromes, musculoskeletal disorders),\n* Children with congenital or acquired orthopedic conditions that prevent completion of the motor tests used in the study,\n* Children with attention, behavioral, or communication difficulties that would prevent completion of the test procedures.\n\nParents\n\n* Individuals who have difficulty communicating in Turkish or are unable to participate in the interview process,\n* Parents who do not complete the interview process, do not consent to audio recording, or voluntarily withdraw from the study were defined as exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT07366957', 'briefTitle': 'Motor Competence and Physical Activity in Children Aged 4-6: Associations With Parental Perceptions', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'Determination of Motor Competence and Physical Activity Levels in Children Aged 4-6 and Their Relationship With Parental Perceptions: A Qualitative Study', 'orgStudyIdInfo': {'id': '2025/15-804'}}, 'armsInterventionsModule': {'armGroups': [{'label': '4-6 Years Old Children and Their Parents', 'description': "This cohort includes typically developing children aged 4-6 years and their parents. Children's motor skills will be assessed using the Peabody Developmental Motor Scales - II (PDMS-II), and parents' perceptions of their children's motor abilities and physical activity will be evaluated through semi-structured interviews. No interventions or treatments will be applied."}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Mudanya University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation/Afyonkarahisar University of Health Sciences - Atatürk Vocational School of Health Services - Physiotherapy Program', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Msc. PT. / Research Assistant', 'investigatorFullName': 'Server ERDOĞMUŞ', 'investigatorAffiliation': 'Mudanya University'}}}}