Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-31 @ 10:10 PM
Study NCT ID:
NCT05511532
Status:
UNKNOWN
Last Update Posted:
2022-10-18
First Post:
2022-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Foot Orthoses & Hallux Limitus in School-age Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020857', 'term': 'Hallux Limitus'}], 'ancestors': [{'id': 'D005531', 'term': 'Foot Deformities, Acquired'}, {'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D018409', 'term': 'Foot Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 51}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-01-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-17', 'studyFirstSubmitDate': '2022-07-28', 'studyFirstSubmitQcDate': '2022-08-22', 'lastUpdatePostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hallux limitus', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'hallux limitus is defined as a limitation of dorsiflexion of the 1st metatarsophalangeal joint of the foot.\n\nIn the functional hallux limitus test, the doctor uses one hand to hold the first ray in a dorsi-flexed position by loading the first metatarsal head and the other hand to dorsiflex the proximal phalanx of the hallux.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['school-age', 'hallux limitus', 'plantar pressures'], 'conditions': ['Hallux Limitus']}, 'descriptionModule': {'briefSummary': 'The most important pivot of the sagittal plane is in the first metatarsophalangeal joint, which is usually restricted or blocked as a result of alterations in the rest of the planes or as the main cause of secondary compensations.', 'detailedDescription': 'In the propulsion phase, once the hallux touches the ground, it does not move again until the moment of take-off, so when there is a limitation of the plantar flexion of the hallux, the compensation of this is appreciated in other anatomical locations during gait analysis.\n\nFor the propulsion phase to be effective, the first metatarsophalangeal joint must be maximally dorsiflexed.\n\nIf any structure or movement is altered, the axis varies. In the hallux, the joint surface on which the movement is performed is reduced and therefore affected at the dorsal level, causing a limitation of the main movement of this joint; dorsiflexion in closed kinetic chain, known as functional hallux limitus.\n\nIt is for this reason that it is proposed to study the application of plantar supports to favor the movement of dorsiflexion of the first metatarsophalangeal joint and avoid an early establishment of the hallux limitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Interest in participating and completing the phases of the study and signing of the informed consent by the parents. Patients who do not meet any exclusion criteria will be included.\n\nExclusion Criteria:\n\n* The exclusion criteria will be refusal to sign the informed consent, hypermobility, neurological diseases, previous traumatic history affecting one or both lower extremities, rheumatic pathologies, as well as patients with an angular value of the first metatarsophalangeal joint less than 10º and ankle flexion less than 10º with the knee in extension.'}, 'identificationModule': {'nctId': 'NCT05511532', 'briefTitle': 'Foot Orthoses & Hallux Limitus in School-age Children', 'organization': {'class': 'OTHER', 'fullName': 'Universidade da Coruña'}, 'officialTitle': 'Analyze the Effectiveness of Plantar Supports in School-age Children With and Without Hallux Limitus', 'orgStudyIdInfo': {'id': 'IRB00003099'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Foot orthoses', 'description': 'Hallux limitus', 'interventionNames': ['Other: Orthopaedic treatment']}], 'interventions': [{'name': 'Orthopaedic treatment', 'type': 'OTHER', 'description': 'Female and male patients aged between 6 and 12 years are included in the study. Initially, the values of dorsiflexion of the tibio-fibular-talar joint and dorsiflexion of the first metatarsophalangeal joint will be measured to rule out hallux rigidus and ankle equinus, respectively.\n\nThose patients who do not present hallux rigidus or equinus ankle, will be included in the study and will have their computerized foot pressures taken.', 'armGroupLabels': ['Foot orthoses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitari Universitat de Barcelona', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '08750', 'city': 'Molins de Rei', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Centre de Podologia CM', 'geoPoint': {'lat': 41.41667, 'lon': 2.01667}}, {'zip': '08750', 'city': 'Molins de Rei', 'state': 'Barcelona', 'status': 'COMPLETED', 'country': 'Spain', 'facility': 'Escola Col·legi Pare Manyanet Molins de Rei-Sant Miquel', 'geoPoint': {'lat': 41.41667, 'lon': 2.01667}}], 'centralContacts': [{'name': 'Claudia Cuevas-Martinez', 'role': 'CONTACT', 'email': 'claudia.cuevas@udc.es', 'phone': '616128112', 'phoneExt': '+34'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade da Coruña', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}