Evaluation of the Static Stability of Footwear

Not Applicable

Completed

• Conditions: Postural; Strain
• Interventions: Device: Stabilometry

• Registration Number: NCT03764332
• Lead Sponsor: JOSE MANUEL SANCHEZ SAEZ

Brief 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.

Study Timeline

• Study First Submitted: 2018-11-27
• Study First Submitted QC: 2018-12-02
• Study First Posted: 2018-12-05
• Study Start: 2018-12-07
• Primary Completion: 2018-12-30
• Status Verified: 2019-01
• Study Completion: 2019-01-04
• Last Update Submitted: 2019-01-04
• Last Update Posted: 2019-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stabilometry	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.

Primary Outcome Measures

Name	Time	Method
Relationship between Length / surface	30 seconds	Value resulting from the relationship between the two previous measures. The Podoprint pressure platform was used as a measuring device.; Quantitative variable
Lateral velocity	30 seconds	Average speed of oscillation in its axis of ordinates. The Podoprint pressure platform was used as a measuring device. Quantitative variable
Average displacement in the X axis	30 seconds	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
Stroke length	30 seconds	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
Average displacement on the Y axis	30 seconds	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
Stroke surface	30 seconds	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
Average swing speed	30 seconds	Average speed that reaches the displacement of the center of pressures. The Podoprint pressure platform was used as a measuring device.; Quantitative variable
Forward speed	30 seconds	Average oscillation speed on its abscissa axis. The Podoprint pressure platform was used as a measuring device. Quantitative variable

Trial Locations

Locations (1)

Clínica López del Amo; 🇪🇸 Murcia, Spain