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:

Study Overview

• Status: Completed
• Conditions: Postural; Strain
• Intervention / Treatment: Device: Stabilometry

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30008
    • Clínica López del Amo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: Stabilometry; To evaluate the static balance of subjects when barefoot and when using three types of footwear with their eyes closed or open.; Other Names: Eyes open and eyes closed

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: JOSE MANUEL SANCHEZ SAEZ
• Investigators: Principal Investigator: Jose Sanchez Saez, Podólogo, Universidade da Coruña

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2018
• Primary Completion (Actual): December 30, 2018
• Study Completion (Actual): January 4, 2019

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: December 2, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): January 7, 2019
• Last Update Submitted That Met QC Criteria: January 4, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Footwear; Barefoot
• Other Study ID Numbers: 1402201803718

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No