Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-19 @ 5:27 PM
Study NCT ID:
NCT02022267
Status:
COMPLETED
Last Update Posted:
2013-12-27
First Post:
2013-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gait Analysis in Ponseti Clubfoot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003025', 'term': 'Clubfoot'}], 'ancestors': [{'id': 'D000070558', 'term': 'Talipes'}, {'id': 'D005531', 'term': 'Foot Deformities, Acquired'}, {'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005532', 'term': 'Foot Deformities, Congenital'}, {'id': 'D038061', 'term': 'Lower Extremity Deformities, Congenital'}, {'id': 'D017880', 'term': 'Limb Deformities, Congenital'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-20', 'studyFirstSubmitDate': '2013-12-07', 'studyFirstSubmitQcDate': '2013-12-20', 'lastUpdatePostDateStruct': {'date': '2013-12-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3D Gait Analysis with foot model', 'timeFrame': 'once at time of presentation for study specific examination; invitations were sent out end of 2011, a second letter three months after the first. After second letter patients had a time frame of three more months to participate before study was closed', 'description': 'Gait analysis, including video recordings with a Vicon motion capture system (Vicon, Oxford, UK) with kinetic data collected from three AMTI force plates (Advanced Mechanical Technology, Inc., Watertown, MA). Placement of markers will be a combination of Cleveland (lower extremity), PlugInGait (upper body), and Oxford Foot (movement within the foot) models.'}], 'secondaryOutcomes': [{'measure': 'Clinical examination', 'timeFrame': 'once at time of presentation for study specific examination; invitations were sent out end of 2011, a second letter three months after the first. After second letter patients had a time frame of three more months to participate before study was closed', 'description': 'Active and passive range of motion (ROM) of the ankle joint measured with a hand-held goniometer. Ability to walk on the heels and on tiptoes.'}, {'measure': 'disease-specific instrument questionnaire', 'timeFrame': 'once at time of presentation for study specific examination; invitations were sent out end of 2011, a second letter three months after the first. After second letter patients had a time frame of three more months to participate before study was closed', 'description': 'questionnaire as described in citation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['clubfoot', 'gait analysis', 'outcome questionaire', 'Ponseti method'], 'conditions': ['Clubfoot']}, 'referencesModule': {'references': [{'pmid': '11176352', 'type': 'BACKGROUND', 'citation': 'Roye BD, Vitale MG, Gelijns AC, Roye DP Jr. Patient-based outcomes after clubfoot surgery. J Pediatr Orthop. 2001 Jan-Feb;21(1):42-9. doi: 10.1097/00004694-200101000-00010.'}]}, 'descriptionModule': {'briefSummary': 'Patients with clubfoot treated with the Ponseti method from a prospective database are evaluated using gait analysis including a foot model and a disease specific instrument score and compared to a group of healthy children.', 'detailedDescription': 'Patients with a minimum age of three years from a prospective, consecutive database of patients with clubfoot treated with the Ponseti method beginning in 2002 are considered for this study. Thereby patients will typically have a follow up of nearly three to eight years after initial clubfoot correction. Patients with unilateral or bilateral idiopathic clubfoot are included. Patients with clubfoot associated with syndromes or neurological diseases, with mild clubfoot that required fewer than three casts for initial correction, who first presented at an age older than three months, who were living outside of the country, and who were initially treated elsewhere with more than three casts are excluded. An invitation letter to participate in the study was sent out at the end of 2011, with a second letter being sent out three months after the first. After the second letter patients had a time frame of three more months to participate before the study was closed.\n\nTo comprise a control group for the purpose of collecting gait analysis data of healthy children, employees of our hospital are asked to allow their children to participate in this study.\n\nEach patient will be physically examined, active and passive range of motion (ROM) of the ankle joint will be measured with a hand-held goniometer. Ability to walk on the heels and on tiptoes will be recorded. The disease-specific instrument questionnaire, which will be blinded for the treating physician will be handed out to fill in.\n\nPatients will undergo gait analysis, including video recordings with a Vicon motion capture system (Vicon, Oxford, UK) with kinetic data collected from three AMTI force plates (Advanced Mechanical Technology, Inc., Watertown, MA). Placement of markers will be a combination of Cleveland (lower extremity), PlugInGait (upper body), and Oxford Foot (movement within the foot) models.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a minimum age of three years from a prospective, consecutive database of patients with clubfoot treated with the Ponseti method beginning in 2002', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unilateral or bilateral idiopathic clubfoot treated with the Ponseti method\n\nExclusion Criteria:\n\n* clubfoot associated with syndromes or neurological diseases\n* mild clubfoot that required fewer than three casts for initial correction\n* clubfoot patients that first presented at an age older than three months\n* clubfoot patients who were living outside of the Country\n* clubfoot patients who were treated elsewhere with more than three casts'}, 'identificationModule': {'nctId': 'NCT02022267', 'briefTitle': 'Gait Analysis in Ponseti Clubfoot', 'organization': {'class': 'OTHER', 'fullName': 'Orthopedic Hospital Vienna Speising'}, 'officialTitle': 'Results of Gait Analysis Including Oxford Foot Model in Children With Clubfoot Treated With the Ponseti Method', 'orgStudyIdInfo': {'id': 'EK10-218-1210'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'study group', 'description': 'Patients with a minimum age of three years from our prospective, consecutive database of patients with clubfoot treated with the Ponseti method beginning in 2002 are considered for this study. Patients with unilateral or bilateral idiopathic clubfoot are included. Patients with clubfoot associated with syndromes or neurological diseases, with mild clubfoot that required fewer than three casts for initial correction, who first presented at an age older than three months, who were living outside of the country, and who were initially treated elsewhere with more than three casts are excluded.'}, {'label': 'control group', 'description': 'healthy children of employees of our hospital'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1130', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Orthopaedic Hospital Speising', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Christof Radler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopaedic Hospital Speising'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orthopedic Hospital Vienna Speising', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof., MD', 'investigatorFullName': 'Christof Radler', 'investigatorAffiliation': 'Orthopedic Hospital Vienna Speising'}}}}