Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-26 @ 12:21 PM
Study NCT ID:
NCT06679166
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-07
First Post:
2024-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fall Frequency in Children With Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-06', 'studyFirstSubmitDate': '2024-11-06', 'studyFirstSubmitQcDate': '2024-11-06', 'lastUpdatePostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of falls', 'timeFrame': '0 day', 'description': 'This study aims to assess presence of falls)in children with cerebral palsy and compare it to healthy controls. By examining factors such as fall location, timing, injury occurrence, and rehabilitation status, the study seeks to identify specific fall risks and patterns in children with cerebral palsy. This data will provide insights for developing targeted interventions to reduce fall frequency and improve safety in this population.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'The aim of this cross-sectional clinical study is to evaluate the frequency of falls in children diagnosed with cerebral palsy and compare it with healthy controls.', 'detailedDescription': 'Our study is designed as a cross-sectional controlled study. A total of 23 children aged 5-12 years diagnosed with cerebral palsy, who can ambulate indoors or in the community either independently or with assistive devices, and 23 healthy children of the same age range will be included. Data will be collected on the age of the patients and healthy volunteers, information about their caregivers, frequency of falls, location and time of falls, education level, type of mobilization, presence of additional conditions, whether they receive rehabilitation, frequency of rehabilitation, duration of hospitalization if applicable, occurrence of falls during hospitalization, and presence of injuries. The collected data will be compared with the healthy controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cerebral palsy and healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 5-12 years.\n* Diagnosed with cerebral palsy (study group) or healthy without cerebral palsy (control group).\n* Ability to ambulate either independently or with assistance indoors or in the community.\n* Consent obtained from the participant or their caregiver (parent or guardian).\n\nExclusion Criteria:\n\n* Refusal to participate in the study.\n* Presence of cognitive impairments.\n* Existence of neuromuscular diseases, other than cerebral palsy, that would impair walking ability or increase fall frequency.'}, 'identificationModule': {'nctId': 'NCT06679166', 'briefTitle': 'Fall Frequency in Children With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Beylikduzu State Hospital'}, 'officialTitle': 'Evaluation of Fall Frequency in Children With Cerebral Palsy: A Controlled Study', 'orgStudyIdInfo': {'id': 'BeylikduzuStateH10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cerebral palsy', 'description': '23 children aged 5-12 years diagnosed with cerebral palsy', 'interventionNames': ['Other: No intervention']}, {'label': 'Healthy children', 'description': 'A total of 23 children aged 5-12 years diagnosed with cerebral palsy and 23 healthy children without a diagnosis of cerebral palsy in the same age range will be included.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Cerebral palsy', 'Healthy children']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34147', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Beylikdüzü State Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Büşra Şirin Ahısha, MD', 'role': 'CONTACT', 'email': 'bsrn080@gmail.com', 'phone': '02124443322'}, {'name': 'Büşra Şirin Ahısha', 'role': 'CONTACT', 'email': 'bsrn080@gmail.com', 'phone': '02124443322'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beylikduzu State Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Busra Sirin', 'investigatorAffiliation': 'Beylikduzu State Hospital'}}}}