Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:55 PM
Study NCT ID:
NCT05879094
Status:
COMPLETED
Last Update Posted:
2023-06-05
First Post:
2023-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Orthopaedic Simulation of Morton's Extension to Test the Effect on Plantar Pressures of Each Metatarsal Head in Patients Without Deformity: A Pre-post-test Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D037061', 'term': 'Metatarsalgia'}], 'ancestors': [{'id': 'D005534', 'term': 'Foot Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-02', 'studyFirstSubmitDate': '2023-05-18', 'studyFirstSubmitQcDate': '2023-05-18', 'lastUpdatePostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Before Morton Extension Medium pressure', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'Static footprint will measure medium plantar pressures of first, second third fourth fifth and midfoot rearfoot and forefoot in Kilopascals (KPa). Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline.'}, {'measure': 'Before Morton Extension Maximum pressure', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'Static footprint will measure maximum plantar pressures of first, second third fourth fifth and midfoot rearfoot and forefoot in Kilopascals (KPa). Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline.'}, {'measure': 'After Morton Extension Medium pressure', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'Static footprint will measure medium plantar pressures of first, second third fourth fifth and midfoot rearfoot and forefoot in Kilopascals (KPa). Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline.'}, {'measure': 'After Morton Extension Maximum pressure', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'Static footprint will measure maximum plantar pressures of first, second third fourth fifth and midfoot rearfoot and forefoot in Kilopascals (KPa). Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['metatarsalgia', 'foot', 'orthopedics'], 'conditions': ['Healthy Subjects']}, 'referencesModule': {'references': [{'pmid': '37835830', 'type': 'DERIVED', 'citation': "Sanchez-Serena A, Losa-Iglesias ME, Becerro-de-Bengoa-Vallejo R, Morales-Ponce A, Soriano-Medrano A, Perez-Boal E, Grande-Del-Arco J, Casado-Hernandez I, Martinez-Jimenez EM. Orthopaedic Simulation of a Morton's Extension to Test the Effect on Plantar Pressures of Each Metatarsal Head in Patients without Deformity: A Pre-Post-Test Study. Diagnostics (Basel). 2023 Sep 28;13(19):3087. doi: 10.3390/diagnostics13193087."}]}, 'descriptionModule': {'briefSummary': "The aim of this study is to simulate the orthopedic treatment called Morton's extension on non-deformed patients to check the effects on each metatarsal head on its static footprint.", 'detailedDescription': 'The objective of this study is to perform an assimilation of the orthopedic treatment called morton extension on non-deformed patients to verify the effects on each metatarsal head on its static footprint, specifically the mean pressures and before and after the application of the morton extension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* no history of trauma to the foot;\n* the presence of at least 10° of dorsiflexion at the ankle with the knee fully dorsiflexed;\n* unrestricted motion of the functional subtalar joint of 30°;\n* unrestricted motion along the longitudinal axis of the midtarsal joint of 15°;\n* unrestricted nonweight-bearing motion of the first ray of at least 8 mm;\n* greater than 50° of dorsiflexion of the hallux to the first metatarsal bisection during nonweight-bearing;\n* age greater than 18 years and younger than 60 years;\n* at the time of data collection, no lower limb dysfunction or chronic injury; and\n* no evidence of a non-fixed deformity at first MTP and first metatarsal cuneiform joints.\n\nExclusion Criteria:\n\n* plantar corns and calluses,\n* hallux valgus and lesser toe deformities,\n* diabetes,\n* any abnormality in the lower extremity that may affect gait.'}, 'identificationModule': {'nctId': 'NCT05879094', 'briefTitle': "Orthopaedic Simulation of Morton's Extension to Test the Effect on Plantar Pressures of Each Metatarsal Head in Patients Without Deformity: A Pre-post-test Study.", 'organization': {'class': 'OTHER', 'fullName': 'Mayuben Private Clinic'}, 'officialTitle': "Orthopaedic Simulation of Morton's Extension to Test the Effect on Plantar Pressures of Each Metatarsal Head in Patients Without Deformity: A Pre-post-test Study.", 'orgStudyIdInfo': {'id': '20/235-E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Morton extension', 'description': 'Experimental group con Morton Extension application', 'interventionNames': ['Other: Morton extension']}], 'interventions': [{'name': 'Morton extension', 'type': 'OTHER', 'description': "A Morton extension with a height of 5 mm was insert from the proximal area of the first metatarsal head to the base of the proximal phalanx of the Hallux of the subjects' bare feet using a paper bandage. The material, shape, size, and thickness of the Morton Extension were the same.", 'armGroupLabels': ['Morton extension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Eva María Martínez-Jimenez', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Eva María Martínez-Jimenez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayuben Private Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayuben Private Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Podiatry, Principal Investigator, and Physiotherapist', 'investigatorFullName': 'EVA MARIA MARTÍNEZ JIMENEZ', 'investigatorAffiliation': 'Mayuben Private Clinic'}}}}