Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-01-01 @ 8:12 PM
Study NCT ID:
NCT02627651
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2015-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Cardiac Autonomic System Response to Activity and Cognitive Tasksinjury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'lastUpdateSubmitDate': '2016-07-18', 'studyFirstSubmitDate': '2015-12-02', 'studyFirstSubmitQcDate': '2015-12-09', 'lastUpdatePostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': '5 min'}, {'measure': 'Heart rate variability- time domain measures', 'timeFrame': '5 min'}, {'measure': 'Heart rate variability- frequency domain measures', 'timeFrame': '5 min'}]}, 'conditionsModule': {'conditions': ['Brain Injuries']}, 'descriptionModule': {'briefSummary': '18 children post acquired brain injury and 18 typically developed controls matched for age and gender.\n\nAll children aged 10-18 yrs who understand simple commands.\n\nTools:\n\n1. Heart rate monitor\n2. Six minute walk test\n3. The behavior rating inventory\n\nMethod:\n\n1. At the introductory visit the child will be asked to walk for six minutes, to sit and perform a cognitive test and then to walk on a treadmill for 5 seconds.\n2. At the second visit the child will be asked to go on the treadmill for 5 minutes and at the same time to perform the cognitive assignment; After a rest the child will be asked to walk on the treadmill for 5 minutes and at the end to perform the cognitive assignment .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\naged 10-18 understand simple commands walk independently\n\nExclusion Criteria:\n\nCanot understand simple commands'}, 'identificationModule': {'nctId': 'NCT02627651', 'briefTitle': 'The Cardiac Autonomic System Response to Activity and Cognitive Tasksinjury', 'organization': {'class': 'OTHER', 'fullName': 'Alyn Pediatric & Adolescent Rehabilitation Hospital'}, 'officialTitle': 'The Cardiac Autonomic System Response to Activity and Cognitive Tasks in Children Post Acquired Brain', 'orgStudyIdInfo': {'id': 'Alyn'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'brain injury', 'description': 'children post brain injury', 'interventionNames': ['Other: cognitive and motor assignments']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'controls', 'description': 'children typically developed age matched', 'interventionNames': ['Other: cognitive and motor assignments']}], 'interventions': [{'name': 'cognitive and motor assignments', 'type': 'OTHER', 'description': 'walking on treadmill, performing cognitive assignment; and performing the cognitive assignment while walking .', 'armGroupLabels': ['brain injury', 'controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91090', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Alyn Pediatric and Adolesencent Rehabilitation Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alyn Pediatric & Adolescent Rehabilitation Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}