Evaluation of the Static Stability of Footwear

Postural; Strain Clinical Trial

— EEECS  

Official title:

Evaluation of the Static Stability of Footwear: A Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03764332
• Other study ID #: 1402201803718
• Status: Completed
• Phase: N/A
• Start date: December 7, 2018
• Est. completion date: January 4, 2019

Study information

• Verified date: January 2019
• Source: Universidade da Coruña
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 4, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Postural; Strain

Intervention

Device:
• Stabilometry
To evaluate the static balance of subjects when barefoot and when using three types of footwear with their eyes closed or open.

Locations

Country	Name	City	State
Spain	Clínica López del Amo	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
JOSE MANUEL SANCHEZ SAEZ

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Forward speed	Average oscillation speed on its abscissa axis. The Podoprint pressure platform was used as a measuring device. Quantitative variable	30 seconds
Primary	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
Primary	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