Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-05 @ 9:41 AM
Study NCT ID:
NCT02839369
Status:
UNKNOWN
Last Update Posted:
2016-07-21
First Post:
2010-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Walking Dynamic Among Children With Brain Damge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'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'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-20', 'studyFirstSubmitDate': '2010-02-28', 'studyFirstSubmitQcDate': '2016-07-20', 'lastUpdatePostDateStruct': {'date': '2016-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'step characteristics', 'timeFrame': '30 minutes', 'description': 'The Gaitrite system - step length and time variability (%).'}], 'secondaryOutcomes': [{'measure': 'step time', 'timeFrame': 'part of the first assessment', 'description': 'step time in sec'}, {'measure': 'step length', 'timeFrame': 'part of the first assessment', 'description': 'step length in cm'}, {'measure': 'gait velocity', 'timeFrame': 'part of the first assessment', 'description': 'walking velocity (cm/sec),'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['walking performance', 'Cerebral Palsy, Typically Developed'], 'conditions': ['Traumatic Brain Injury', 'Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'The goal of the present study was to look at the effect of changing walking parameters on the dynamic walking characteristics among children post severe traumatic brain injury, children with cerebral palsy and typically developed controls.', 'detailedDescription': 'leisure time physical activity by the Godin and Shephard (G\\&S) questionnaire. Balance tests - the Timed Up and Go test (TUG) and functional reach test (FRT). Maximal isometric strength was assessed by using a hand held dynamometer; walking dynamics were recorded by an electronic mat, and the 6 minute walk test, energy expenditure index (EEI) and perceived exertion by the OMNI scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children post Traumatic Brain Injury with Cerebral palsy Typically Developed', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPost Traumatic Brain Injury\n\n* Post severe closed head injury (Glasgow Coma Scale (GCS) score at admission to emergency room of ≤8\n* At least one year post trauma\n* Ages 7 to 13 years\n* Independent ambulation (foot orthoses permitted)\n\nChildren with Cerebral palsy\n\n* GMFCS 1 or 2\n* Ages 7 to 13 years\n* Able to stand up from a chair independently and maintain standing for more than 5 seconds without falling, without obvious limitation in the passive range of motion of lower extremities.\n\nTypically Developed age and sex controls exclusion criteria:\n\n* Children who could not fulfill simple instructions'}, 'identificationModule': {'nctId': 'NCT02839369', 'briefTitle': 'Walking Dynamic Among Children With Brain Damge', 'organization': {'class': 'OTHER', 'fullName': 'Alyn Pediatric & Adolescent Rehabilitation Hospital'}, 'officialTitle': 'The Effect of Changing Walking Conditions on Walking Dynamic Characteristics Among Children Post a Severe Traumatic Brain Injury, Cerebral Palsy and Typically Developed (TD) Control.', 'orgStudyIdInfo': {'id': '158-08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'children', 'description': 'post Traumatic Brain Injury With Cerebral Palsy Typically developed', 'interventionNames': ['Other: walking under varies conditions']}], 'interventions': [{'name': 'walking under varies conditions', 'type': 'OTHER', 'description': 'The children were asked to walk an electronic mat, three cycles for each one of the different trials as comfortable regular speed, walking as fast and as slow as possible, walking on straight line etc', 'armGroupLabels': ['children']}, {'name': 'walking under varies conditions', 'type': 'OTHER', 'description': 'walking on electronic walkway under different conditions', 'armGroupLabels': ['children']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91090', 'city': 'Jerusalem', 'country': 'Israel', 'facility': "Alyn Children's Rehabilitation Hospital", 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alyn Pediatric & Adolescent Rehabilitation Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}