Evaluation of the Static Stability of Footwear (EEECS)
Evaluation of the Static Stability of Footwear: A Clinical Trial
Introduction: Postural control is a crucial factor for maintaining balance while standing and walking. The shoe has a role to play in postural stability.
Objectives: To evaluate the static balance of subjects when barefoot and when using three types of footwear with their eyes closed or open.
Material and methods:
Studie Overzicht
Gedetailleerde beschrijving
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.
The 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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Murcia, Spanje, 30008
- Clínica López del Amo
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Acceptance and signature of informed consent.
- Persons aged between 25-35 years.
- People with a weight between 40 and 95kg.
- People with a height between 1.50 and 1.90m
Exclusion Criteria:
- People with surgical history of lower limbs.
- People with systemic pathology / algia that can alter the physiological static pattern.
- Congenital deformities or acquired in childhood.
- 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.
- Patients who do not accept or sign the informed consent
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Ander: Stabilometry
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.
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To evaluate the static balance of subjects when barefoot and when using three types of footwear with their eyes closed or open.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Stroke length
Tijdsspanne: 30 seconds
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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. Quantitative variable |
30 seconds
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Stroke surface
Tijdsspanne: 30 seconds
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Area of the smallest ellipse able to encompass the oscillating ball. In mm. The Podoprint pressure platform was used as a measuring device. Quantitative variable |
30 seconds
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Relationship between Length / surface
Tijdsspanne: 30 seconds
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Value resulting from the relationship between the two previous measures. The Podoprint pressure platform was used as a measuring device. Quantitative variable |
30 seconds
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Average swing speed
Tijdsspanne: 30 seconds
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Average speed that reaches the displacement of the center of pressures. The Podoprint pressure platform was used as a measuring device. Quantitative variable |
30 seconds
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Lateral velocity
Tijdsspanne: 30 seconds
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Average speed of oscillation in its axis of ordinates.
The Podoprint pressure platform was used as a measuring device.
Quantitative variable
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30 seconds
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Forward speed
Tijdsspanne: 30 seconds
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Average oscillation speed on its abscissa axis.
The Podoprint pressure platform was used as a measuring device.
Quantitative variable
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30 seconds
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Average displacement in the X axis
Tijdsspanne: 30 seconds
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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. Quantitative variable |
30 seconds
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Average displacement on the Y axis
Tijdsspanne: 30 seconds
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Average of the displacements made by the center of pressures on the abscissa axis. The Podoprint pressure platform was used as a measuring device. Quantitative variable |
30 seconds
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Jose Sanchez Saez, Podólogo, Universidade da Coruña
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 1402201803718
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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