Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT05579535
Status:
COMPLETED
Last Update Posted:
2022-10-13
First Post:
2022-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Weight on Hip Excursion During Gait
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020233', 'term': 'Gait Disorders, Neurologic'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-11', 'studyFirstSubmitDate': '2022-10-10', 'studyFirstSubmitQcDate': '2022-10-11', 'lastUpdatePostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hip excursion', 'timeFrame': '3 months', 'description': 'hip excursion during gait cycle'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ankle;', 'diplegia', 'gait', 'hip excursion', 'weight'], 'conditions': ['Gait, Spastic']}, 'referencesModule': {'references': [{'pmid': '11851738', 'type': 'BACKGROUND', 'citation': 'Rodda J, Graham HK. Classification of gait patterns in spastic hemiplegia and spastic diplegia: a basis for a management algorithm. Eur J Neurol. 2001 Nov;8 Suppl 5:98-108. doi: 10.1046/j.1468-1331.2001.00042.x.'}]}, 'descriptionModule': {'briefSummary': 'Background: Children with diplegia had considerably larger hip and knee excursion during gait cycle than did normal developing children.\n\nObjective: To investigate the effect of using weight around the ankle on hip excursion in children with diplegia.', 'detailedDescription': 'Fifty children with spastic diplegic cerebral palsy were assigned into two groups at random (A, B). Both groups had received the same prescribed exercise program with classical gait training for group A and gait training while using weight around ankle for group B. Treatment was conducted for one hour three sessions per week for successive 3 months. Two-dimensional (2D) gait analysis was used to evaluate hip excursion throughout the gait cycle before and after three months of therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* able to follow simple basic commands,\n* identified with gait abnormalities described as level II on Gross Motor Function Classification System (GMFCS).\n* diagnosed as spastic diplegia.\n\nExclusion Criteria:\n\n* severe visual or auditory problems,\n* lower limb surgical orthopaedic surgery or\n* BOTOX injection in the six months preceding the start of the study,\n* and uncontrolled seizures.'}, 'identificationModule': {'nctId': 'NCT05579535', 'briefTitle': 'Effect of Weight on Hip Excursion During Gait', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Weight on Hip Excursion During Gait in Children With Diplegia', 'orgStudyIdInfo': {'id': 'weight during gait'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group A', 'description': 'classical gait training', 'interventionNames': ['Other: gait training exercises']}, {'type': 'EXPERIMENTAL', 'label': 'group B', 'description': 'gait training while using weight around ankle', 'interventionNames': ['Other: gait training exercises']}], 'interventions': [{'name': 'gait training exercises', 'type': 'OTHER', 'otherNames': ['gait rehabilitation'], 'description': 'walking exercises in different directions', 'armGroupLabels': ['group A', 'group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'Nahla', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Nahla mohamed, phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'after published online', 'ipdSharing': 'YES', 'description': 'available when contact the corresponding author including protocol', 'accessCriteria': 'authors'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer at pediatric department faculty of physical therapy', 'investigatorFullName': 'Nahla Mohamed Ibrahim', 'investigatorAffiliation': 'Cairo University'}}}}