- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03764332
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:
Aperçu de l'étude
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Murcia, Espagne, 30008
- Clínica López del Amo
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Autre: 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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Stroke length
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jose Sanchez Saez, Podólogo, Universidade da Coruña
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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