Clinical Trials Directory

Trials / Completed

CompletedNCT03764332

Evaluation of the Static Stability of Footwear

Evaluation of the Static Stability of Footwear: A Clinical Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
26 (actual)
Sponsor
JOSE MANUEL SANCHEZ SAEZ · Academic / Other
Sex
All
Age
25 Years – 35 Years
Healthy volunteers
Accepted

Summary

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:

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DEVICEStabilometryTo evaluate the static balance of subjects when barefoot and when using three types of footwear with their eyes closed or open.

Timeline

Start date
2018-12-07
Primary completion
2018-12-30
Completion
2019-01-04
First posted
2018-12-05
Last updated
2019-01-07

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT03764332. Inclusion in this directory is not an endorsement.