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Evaluation of the Static Stability of Footwear (EEECS)

J

JOSE MANUEL SANCHEZ SAEZ

Status

Completed

Conditions

Postural; Strain

Treatments

Device: Stabilometry

Study type

Interventional

Funder types

Other

Identifiers

NCT03764332
1402201803718

Details and patient eligibility

About

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:

Full 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.

Enrollment

26 patients

Sex

All

Ages

25 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

26 participants in 1 patient group

Stabilometry
Other group
Description:
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.
Treatment:
Device: Stabilometry

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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