Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-31 @ 3:33 AM
Study NCT ID:
NCT05696535
Status:
UNKNOWN
Last Update Posted:
2023-01-25
First Post:
2023-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Relationship Between Lower and Upper Extremity Selective Motor Control and Sensory Functions in Children With Spastic Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-13', 'studyFirstSubmitDate': '2023-01-13', 'studyFirstSubmitQcDate': '2023-01-13', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of selective motor control function', 'timeFrame': '2 months'}], 'secondaryOutcomes': [{'measure': 'The relationship between selective motor control and sensory functions', 'timeFrame': '3 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spastic Cerebral Palsy', 'Motor Activity', 'Lower Extremity Problem', 'Upper Extremity Problem']}, 'descriptionModule': {'briefSummary': 'Although spasticity, contractures and muscle weakness in children with CP are disorders that can be observed more easily and are more focused and given more importance in evaluation and treatment approaches; Inadequate or loss of selective motor control negatively affects motor functions to a greater extent.\n\nIt is very important to reveal the causes and consequences of selective motor disability in children with spastic cerebral palsy, in terms of creating effective treatment plans.\n\nThe number of patients to participate in the study was determined as 100. The study will be carried out in Hatay Mustafa Kemal University Research and Application Hospital, Department of Pediatrics.\n\nIn our study, demographic information will be filled in, and lower extremity selective control assessment scale (SCALE) for lower extremity, upper extremity selective control scale (SCUES) for upper extremity, and sensory assessment (touch, two-point discrimination and proprioceptive sensory assessment) will be performed on the patients who accepted the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with spastic cerebral palsy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Giving consent to participate in the study\n* To be diagnosed with spastic type cerebral palsy;\n* Being between the ages of 4-18;\n* Being at level I-II-III according to the gross motor function classification system (GMFCS);\n* Not having undergone Botulinum Toxin injection/lower-upper extremity surgery in the last 6 months\n\nExclusion criteria:\n\n* To be in level IV-V according to gross motor function classification system (GMFCS)\n* Having severe mental retardation who does not understand verbal commands'}, 'identificationModule': {'nctId': 'NCT05696535', 'briefTitle': 'Investigation of the Relationship Between Lower and Upper Extremity Selective Motor Control and Sensory Functions in Children With Spastic Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Mustafa Kemal University'}, 'officialTitle': 'Investigation of the Relationship Between Lower and Upper Extremity Selective Motor Control and Sensory Functions in Children With Spastic Cerebral Palsy', 'orgStudyIdInfo': {'id': '22B058'}}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data entry is planned as patients are included in the study and data are collected. A timetable has not been foreseen yet.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mustafa Kemal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist', 'investigatorFullName': 'Fırat Cicekli', 'investigatorAffiliation': 'Mustafa Kemal University'}}}}