Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT07149051
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2025-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Design of a Sensory Integration Intervention Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2025-08-18', 'studyFirstSubmitQcDate': '2025-08-26', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensory Integration Ability', 'timeFrame': 'Month 3', 'description': "Sensory integration ability was measured using the Participants' Sensory Integration Development Evaluation Scale. The scale consists of 58 items rated on a five-point Likert scale and covers vestibular function, tactile defensiveness, proprioception, learning ability, and special problems; the last dimension was excluded due to the participants' age. Assessments were conducted at baseline and at three months."}, {'measure': 'Speed Test', 'timeFrame': 'Month 3', 'description': 'was measured using the 50 m sprint. Assessments were conducted at baseline and at three months.'}, {'measure': 'Flexibility Test', 'timeFrame': 'Month 3', 'description': 'Flexibility was measured using the sit-and-reach test. Assessments were conducted at baseline and at three months.'}, {'measure': 'Coordination Test', 'timeFrame': 'Month 3', 'description': 'Coordination was measured using the one-minute rope skipping test. Assessments were conducted at baseline and at three months.'}, {'measure': 'Balance Test', 'timeFrame': 'Month 3', 'description': 'Balance was measured using the single-leg stance with eyes closed. Assessments were conducted at baseline and at three months.'}, {'measure': 'Lower-limb strength Test', 'timeFrame': 'Month 3', 'description': 'Lower-limb strength was measured using the standing long jump. Assessments were conducted at baseline and at three months.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sensory Integration Disorder']}, 'descriptionModule': {'briefSummary': 'This study aims to explore the mechanisms of motor skill promotion and sensory integration intervention for first-grade primary school students with sensory integration dysfunction. By designing a gamified exercise intervention program tailored to lower-grade students, and combining it with the assessment and analysis of sensory integration functions, the study seeks to systematically improve their sensory integration ability and physical fitness, thereby supporting healthy growth and enhanced adaptability during this critical stage of physical and psychological development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 6 and 7 years;\n* Diagnosis of sensory integration dysfunction in at least one subscale of the assessment tool;\n* Informed consent was obtained from both legal guardians and teachers.\n\nExclusion Criteria:\n\n* Physical deformities or other conditions limiting participation in physical activities;\n* Serious medical conditions;\n* Severe cognitive impairments that could interfere with comprehension or participation in the intervention.'}, 'identificationModule': {'nctId': 'NCT07149051', 'briefTitle': 'Design of a Sensory Integration Intervention Program', 'organization': {'class': 'OTHER', 'fullName': 'Northeast Normal University'}, 'officialTitle': 'Design and Implementation of a Gamified Sensory Integration Exercise Intervention', 'orgStudyIdInfo': {'id': 'CCEE2055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'The intervention program consists of gamified physical activities, incorporating game elements such as game scenarios, mechanisms, and components into the teaching content.', 'interventionNames': ['Behavioral: Gamified Sensory Integration Exercise Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants in the control group received the regular physical education curriculum.'}], 'interventions': [{'name': 'Gamified Sensory Integration Exercise Program', 'type': 'BEHAVIORAL', 'description': 'This study implemented a gamified physical activity intervention aimed at improving sensory integration abilities among first-grade students with sensory processing difficulties. The intervention program incorporated game narratives, mechanisms, and components into physical education activities, guided by the Octalysis Framework to strategically engage both extrinsic (e.g., rewards, rankings) and intrinsic (e.g., creativity, social interaction, meaning) motivational drives.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130024', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'Chinese Center of Exercise Epidemiology', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northeast Normal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Guang Yang, Prof. Dr.', 'investigatorAffiliation': 'Northeast Normal University'}}}}