Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-02-22 @ 12:23 PM
Study NCT ID:
NCT07140159
Status:
COMPLETED
Last Update Posted:
2025-08-24
First Post:
2025-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomechanical Analysis of Gait
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2025-08-06', 'studyFirstSubmitQcDate': '2025-08-21', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metatarsophalangeal Joint Angle', 'timeFrame': 'Baseline', 'description': 'This angle comprises the supplementary angle formed by the first metatarsal head, posterior calcaneus, and proximal interphalangeal. The angle is measured using a marker-based motion capture system with blue markers placed on these points and recorded with cameras operating at 60 frames per second. A centroid-based landmark detection algorithm determines the centroid coordinates and applies trigonometric functions to each frame to calculate the angle in degrees with a precision of two decimal places.'}, {'measure': 'Medial Longitudinal Arch Angle', 'timeFrame': 'Baseline', 'description': 'This angle is defined by the anthropometric landmarks of the calcaneus, the navicular tuberosity, and the head of the first metatarsal. The angle is measured using a marker-based motion capture system with blue markers placed on these points and recorded with cameras operating at 60 frames per second. A centroid-based landmark detection algorithm determines the centroid coordinates and applies trigonometric functions to each frame to calculate the angle in degrees with a precision of two decimal places.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Biomechanical Assessment of the Foot During Gait']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.youtube.com/watch?v=dLADQdmE2nk', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study measures the medial longitudinal arch angle and the metatarsophalangeal angle during the gait cycle in 35 healthy participants using speed cameras and reflective markers placed on anthropometric points.', 'detailedDescription': 'The medial longitudinal arch angle comprises the calcaneus, navicular tuberosity, and the head of the 1st metatarsal, while the metatarsophalangeal angle comprises the head of the 1st metatarsal and the proximal interphalangeal joint of the toe. These measurements provide valuable information on the stress of the plantar fascia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy adult volunteers aged 18 to 43 years, with no history of foot deformities.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy participants\n* Aged between 18 and 43 years\n* Foot sizes ranging from US 5 to 12\n* Body weights between 53 to 125 kg\n* Heights from 1.49 to 1.90 m\n* BMI ranging from 21.8 to 39.9 kg/m².\n\nExclusion Criteria:\n\n* Pes planus (flatfoot)\n* Pes cavus (high-arched foot)\n* Valgus rearfoot\n* Varus rearfoot\n* Foot deformities'}, 'identificationModule': {'nctId': 'NCT07140159', 'briefTitle': 'Biomechanical Analysis of Gait', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Politécnica de Baja California'}, 'officialTitle': 'Recurrent Neural Networks for Windlass Mechanism Subphase Recognition and Anthropometric Angles Monitoring', 'orgStudyIdInfo': {'id': 'Approval Number 02/25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal gait group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21376', 'city': 'Mexicali', 'state': 'Estado de Baja California', 'country': 'Mexico', 'facility': 'Universidad politécnica de baja california', 'geoPoint': {'lat': 32.62781, 'lon': -115.45446}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Politécnica de Baja California', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research-Professor', 'investigatorFullName': 'Gabriel Trujillo-Hernández', 'investigatorAffiliation': 'Universidad Politécnica de Baja California'}}}}