Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT00338858
Status:
COMPLETED
Last Update Posted:
2011-02-15
First Post:
2006-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Connection Between Gait Variability Parameters and Balance Performance in Children With Physical Disability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D002547', 'term': 'Cerebral Palsy'}], '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'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016138', 'term': 'Walking'}, {'id': 'D053580', 'term': 'Muscle Strength'}], 'ancestors': [{'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-06', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-14', 'studyFirstSubmitDate': '2006-06-19', 'studyFirstSubmitQcDate': '2006-06-19', 'lastUpdatePostDateStruct': {'date': '2011-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Brain Injury', 'Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the connection between gait variability parameters and balance performance in children with physical disability', 'detailedDescription': 'Step length and step time variability will be measured with an electronic walkway, strength of 4 lower-extremity muscle groups will be tested bilaterally with a hand held dynamometer, walking performance as will be assessed by the 2 minute walk test, energy expenditure index (EEI) and rating of perceived exertion (OMNI scale).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n3 years of age and older Ambulate, with or without an aid\n\n\\-\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00338858', 'briefTitle': 'The Connection Between Gait Variability Parameters and Balance Performance in Children With Physical Disability', 'organization': {'class': 'OTHER', 'fullName': 'Alyn Pediatric & Adolescent Rehabilitation Hospital'}, 'officialTitle': 'The Connection Between Gait Variability Parameters and Balance Performance in Children With Physical Disability', 'orgStudyIdInfo': {'id': 'alyn2CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'TD', 'interventionNames': ['Other: walking and balance performance evaluation', 'Procedure: muscle strength, walking and balance performance']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'TBI', 'interventionNames': ['Other: walking and balance performance evaluation', 'Procedure: muscle strength, walking and balance performance']}, {'type': 'EXPERIMENTAL', 'label': 'a', 'description': 'Cerebral palsy', 'interventionNames': ['Other: walking and balance performance evaluation', 'Procedure: muscle strength, walking and balance performance']}], 'interventions': [{'name': 'walking and balance performance evaluation', 'type': 'OTHER', 'armGroupLabels': ['1', '2', 'a']}, {'name': 'muscle strength, walking and balance performance', 'type': 'PROCEDURE', 'description': 'HHD- muscle strength, Balance performance - TUG, FRT, Walking performance- gaiterite and 2 min walk test', 'armGroupLabels': ['1', '2', 'a']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91090', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Alyn Pediatric and Adolescent Rehabilitation Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Hemda Rotem, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alyn Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alyn Pediatric & Adolescent Rehabilitation Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Katz-Leurer', 'oldOrganization': 'Alyn Hospital'}}}}