Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2026-04-13 @ 10:18 PM
Study NCT ID:
NCT02633566
Status:
COMPLETED
Last Update Posted:
2015-12-17
First Post:
2015-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of the Effect of Functional Orthoses in Children With Flat Feet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-03-04', 'releaseDate': '2016-02-06'}], 'estimatedResultsFirstSubmitDate': '2016-02-06'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005413', 'term': 'Flatfoot'}], '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-14', 'studyFirstSubmitDate': '2015-12-10', 'studyFirstSubmitQcDate': '2015-12-14', 'lastUpdatePostDateStruct': {'date': '2015-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'X-ray measurements of the angles: talus-calcaneus, talus-navicular and talus-first metatarsal angle.', 'timeFrame': 'One year', 'description': 'Before delivering the treatment, all subjects underwent dorsoplantar radiography, repeated at the end of the treatment (after one year). Differences in the talus-calcaneus, tibionavicular and talus-first metatarsal angles were compared, pre and post-treatment of both study groups. Test analysis of covariance (ANCOVA) was performed as a sataistical test.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Flatfoot', 'orthoses', 'children'], 'conditions': ['Flexible Flatfoot']}, 'referencesModule': {'references': [{'pmid': '35080267', 'type': 'DERIVED', 'citation': 'Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 26;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub4.'}, {'pmid': '35029841', 'type': 'DERIVED', 'citation': 'Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 14;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficay of functional plantar orthoses on flatfoot in children.', 'detailedDescription': "There's a considerable controversy regarding the effectiveness of plantar orthoses in the treatment of flexible flat foot, despite being the most widely used treatment. Several studies tried to investigate the correction of the deformity using plantar orthoses, but there are few studies with a control group of people, not enough to compare the effectiveness of the treatment.\n\nA randomized, double-blind, parallel design clinical trial was conducted with two study groups. The sample consisted of 61 children, aged 3 and 4 years old, who were randomly assigned to each study group. One group (intervention group) received treatment with functional plantar orthotics, and the other group (control group) received treatment with placebo-type plantar orthotics, to use as a reference or comparison. Both groups were followed for a one-year period. Before delivering the treatment, all subjects underwent dorsoplantar radiography, repeated at the end of the treatment (after one year). Differences in the talus-calcaneus, tibionavicular and talus-first metatarsal angles were compared, pre and post-treatment of both study groups. Test analysis of covariance (ANCOVA) was performed as a statistical test."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Flexible flatfoot\n\nExclusion Criteria:\n\n* Congenital Vertical talus\n* Tarsal coalition\n* Neuromuscular disease\n* Ligamentous laxity\n* Previous history of surgery on lower limb\n* Previous orthotic treatment'}, 'identificationModule': {'nctId': 'NCT02633566', 'briefTitle': 'Clinical Trial of the Effect of Functional Orthoses in Children With Flat Feet', 'organization': {'class': 'INDIV', 'fullName': 'Fresno, Raquel Lopez, M.D.'}, 'officialTitle': 'Randomized Clinical Trial of the Effect of Functional Orthoses on the Joint Position of the Hindfoot in Children With Flat Feet After a Year of Follow-up', 'orgStudyIdInfo': {'id': '1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Functional plantar orthoses', 'description': 'Functional plantar orthoses in polypropylene with Medial Heel Skive technique', 'interventionNames': ['Device: Plantar orthoses']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo plantar orthoses', 'description': 'Plantar orthoses made in Ethil Vinyl Acetate (22ยบ Shore) without correction of the pronation', 'interventionNames': ['Device: Plantar orthoses']}], 'interventions': [{'name': 'Plantar orthoses', 'type': 'DEVICE', 'armGroupLabels': ['Functional plantar orthoses', 'Placebo plantar orthoses']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Javier Pascual Huerta, PhD', 'role': 'STUDY_DIRECTOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresno, Raquel Lopez, M.D.', 'class': 'INDIV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student (Podiatrist)', 'investigatorFullName': 'Raquel Lopez Fresno', 'investigatorAffiliation': 'Fresno, Raquel Lopez, M.D.'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-02-06', 'type': 'RELEASE'}, {'date': '2016-03-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Raquel Lopez Fresno, PhD Student (Podiatrist), Fresno, Raquel Lopez, M.D.'}}}}