Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-29 @ 12:11 AM
Study NCT ID:
NCT05913934
Status:
UNKNOWN
Last Update Posted:
2023-06-22
First Post:
2023-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clubfeet and Twins and Gait Analysis
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077107', 'term': 'Gait Analysis'}], 'ancestors': [{'id': 'D005684', 'term': 'Gait'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000076604', 'term': 'Physical Functional Performance'}, {'id': 'D010809', 'term': 'Physical Fitness'}, {'id': 'D006262', 'term': 'Health'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-21', 'studyFirstSubmitDate': '2023-05-19', 'studyFirstSubmitQcDate': '2023-06-21', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in gait analyses of treated clubfeet and their healthy twin siblings: p-value', 'timeFrame': '2 years', 'description': 'The gait analyses parameters are statistically compared between the healhy siblings and the clubfoot twins. The p-values descibe the disparity among the groups. p-values below 0.05 point to a statistical difference and are a clue to insufficient therapy.'}, {'measure': 'Differences in gait analyses of treated clubfeet and their healthy twin siblings:Effect size', 'timeFrame': '2 years', 'description': 'The effect size is a measure for the interpretation of differences. It represents the shift between the standard curves of the two populations. Effect sizes of more than ±0.5 suggests a serious discrepancy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clubfoot', 'gait analysis', 'twin comparison', 'inertial sensor', 'footscan', 'manual-dynamic physiotherapy', 'derotation'], 'conditions': ['Clubfoot']}, 'descriptionModule': {'briefSummary': 'Children with clubfeet who were exclusively treated by Ursula Issler-Wüthrich for 3 to 14 years with manual-dynamic physiotherapy and their healthy twin siblings are compared using gait analysis.\n\nGaitUp sensors (kinematic) and footscan V9 (kinetic) are the systems used for this comparison.\n\nNonparametric statistics are applied to verify aberrations.', 'detailedDescription': 'Control gait analysis in clubfoot children and comparison with their healthy twins\n\nClubfeet are the most common birth defect with about 80 cases in Switzerland per year. There are two important therapies: Ponseti and manual-dynamic physiotherapy.\n\nUrsula Issler-Wüthrich, physiotherapist, since twenty years treats exclusively clubfeet and comorbidities with clubfeet like arthrogryposis and myelomeningocele. Until today she corrected more than 400 feet with manual-dynamic physiotherapy.\n\nAmong her patients there are 11 twin pairs. In the scientific literature it is stated that in unilateral clubfoot, the other foot cannot be considered normal.With the two gait analysis systems meant for controlling the therapy results, the walking pattern of the healthy twin was compared with the pattern of the affected twin sibling.\n\nThe basis of the study is a walk over 25 meters with the GaitUp sensors (11 g) resulting in 22 quantitative digital parameters and tests on the pedobarographic plate footscan V9 leading to 10 parameters.\n\nStatistically it will be analyzed whether there is a discrepancy between the clubfeet children and their healthy twins.\n\nThe parents in writing and the children orally gladly approved the task.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children from 3 to 14 years old, beeing treated for clubfeet and their healthy twins.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Twins with clubfeet\n\nExclusion Criteria:\n\n* All other clubfeet'}, 'identificationModule': {'nctId': 'NCT05913934', 'briefTitle': 'Clubfeet and Twins and Gait Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Dr.Joller BioMedical Consulting'}, 'officialTitle': 'Control Gait Analysis in Clubfoot Children and Comparison With Their Healthy Twins', 'orgStudyIdInfo': {'id': 'ID 2023-00290'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gait analysis parameters', 'description': 'Twins: Gait analysis', 'interventionNames': ['Behavioral: Gait analysis']}], 'interventions': [{'name': 'Gait analysis', 'type': 'BEHAVIORAL', 'description': 'Walk over 25 meters in a gym (GaitUp) Walk over 6 meters with footscan v9 in the office', 'armGroupLabels': ['Gait analysis parameters']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8057', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Dr.Joller BioMedical Consulting', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Peter Joller, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dr.Joller BioMedical Consulting'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr.Joller BioMedical Consulting', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}