Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT03764332
Status:
COMPLETED
Last Update Posted:
2019-01-07
First Post:
2018-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Static Stability of Footwear
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013180', 'term': 'Sprains and Strains'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-04', 'studyFirstSubmitDate': '2018-11-27', 'studyFirstSubmitQcDate': '2018-12-02', 'lastUpdatePostDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stroke length', 'timeFrame': '30 seconds', 'description': 'Length traveled by the pressure center (CoP), forming a line called oscillatory ball. In mm. The Podoprint pressure platform was used as a measuring device.\n\nQuantitative variable'}, {'measure': 'Stroke surface', 'timeFrame': '30 seconds', 'description': 'Area of the smallest ellipse able to encompass the oscillating ball. In mm. The Podoprint pressure platform was used as a measuring device.\n\nQuantitative variable'}, {'measure': 'Relationship between Length / surface', 'timeFrame': '30 seconds', 'description': 'Value resulting from the relationship between the two previous measures. The Podoprint pressure platform was used as a measuring device.\n\nQuantitative variable'}, {'measure': 'Average swing speed', 'timeFrame': '30 seconds', 'description': 'Average speed that reaches the displacement of the center of pressures. The Podoprint pressure platform was used as a measuring device.\n\nQuantitative variable'}, {'measure': 'Lateral velocity', 'timeFrame': '30 seconds', 'description': 'Average speed of oscillation in its axis of ordinates. The Podoprint pressure platform was used as a measuring device. Quantitative variable'}, {'measure': 'Forward speed', 'timeFrame': '30 seconds', 'description': 'Average oscillation speed on its abscissa axis. The Podoprint pressure platform was used as a measuring device. Quantitative variable'}, {'measure': 'Average displacement in the X axis', 'timeFrame': '30 seconds', 'description': 'Average of the displacements made by the center of pressures in the axis of ordinates. The Podoprint pressure platform was used as a measuring device.\n\nQuantitative variable'}, {'measure': 'Average displacement on the Y axis', 'timeFrame': '30 seconds', 'description': 'Average of the displacements made by the center of pressures on the abscissa axis. The Podoprint pressure platform was used as a measuring device.\n\nQuantitative variable'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Footwear', 'Barefoot'], 'conditions': ['Postural; Strain']}, 'referencesModule': {'references': [{'pmid': '31208123', 'type': 'DERIVED', 'citation': 'Sanchez-Saez JM, Palomo-Lopez P, Becerro-de-Bengoa-Vallejo R, Calvo-Lobo C, Losa-Iglesias ME, Lopez-Del-Amo-Lorente A, Lopez-Lopez D. Stability of Three Different Sanitary Shoes on Healthcare Workers: A Cross-Sectional Study. Int J Environ Res Public Health. 2019 Jun 16;16(12):2126. doi: 10.3390/ijerph16122126.'}]}, 'descriptionModule': {'briefSummary': 'Introduction: Postural control is a crucial factor for maintaining balance while standing and walking. The shoe has a role to play in postural stability.\n\nObjectives: To evaluate the static balance of subjects when barefoot and when using three types of footwear with their eyes closed or open.\n\nMaterial and methods:', 'detailedDescription': 'Each participant was asked to focus on a white mark 2 cm in diameter, positioned on a screen 2 m in front of them at eye level. This was done to standardize the data collection and minimize any variation in postural stability caused by changes in the visual field. Each participant was asked to remain in this position for a period of 30 seconds, while the data was collected. Three repetitions were made for each condition to obtain an average value. The condition on footwear and open / closed eyes was randomized to reduce the learning effect. On the other hand to reduce fatigue, each participant was allowed to rest for 5 minutes between shoe changes.\n\nThe size of the sample was calculated with the software of the Clinical Epidemiology and Biostatistics Unit. Complexo Hospitalario Universitario de A Coruña. University of A Coruña (www.fisterra.com). The estimated sample size estimated was calculated to be at least 16 subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acceptance and signature of informed consent.\n* Persons aged between 25-35 years.\n* People with a weight between 40 and 95kg.\n* People with a height between 1.50 and 1.90m\n\nExclusion Criteria:\n\n* People with surgical history of lower limbs.\n* People with systemic pathology / algia that can alter the physiological static pattern.\n* Congenital deformities or acquired in childhood.\n* If after a complete exploration in decubitus, sitting, static standing and gait dynamics, any anomaly that could negatively influence the acquisition of data for the study was detected.\n* Patients who do not accept or sign the informed consent'}, 'identificationModule': {'nctId': 'NCT03764332', 'acronym': 'EEECS', 'briefTitle': 'Evaluation of the Static Stability of Footwear', 'organization': {'class': 'OTHER', 'fullName': 'Universidade da Coruña'}, 'officialTitle': 'Evaluation of the Static Stability of Footwear: A Clinical Trial', 'orgStudyIdInfo': {'id': '1402201803718'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Stabilometry', 'description': 'The Podoprint pressure platform was used as a measuring device. The Podoprint platform is a low profile floor platform consisting of 1.4 sensors / cm2 with a sampling frequency of 40Hz.', 'interventionNames': ['Device: Stabilometry']}], 'interventions': [{'name': 'Stabilometry', 'type': 'DEVICE', 'otherNames': ['Eyes open and eyes closed'], 'description': 'To evaluate the static balance of subjects when barefoot and when using three types of footwear with their eyes closed or open.', 'armGroupLabels': ['Stabilometry']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30008', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Clínica López del Amo', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}], 'overallOfficials': [{'name': 'Jose Sanchez Saez, Podólogo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade da Coruña'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JOSE MANUEL SANCHEZ SAEZ', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'JOSE MANUEL SANCHEZ SAEZ', 'investigatorAffiliation': 'Universidade da Coruña'}}}}