Evaluation of the Static Stability of Footwear

NCT ID: NCT03764332

Last Updated: 2019-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-07

Study Completion Date

2019-01-04

Brief Summary

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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

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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

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Postural; Strain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Stabilometry

Intervention Type DEVICE

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

Interventions

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Stabilometry

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

Intervention Type DEVICE

Other Intervention Names

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Eyes open and eyes closed

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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JOSE MANUEL SANCHEZ SAEZ

OTHER

Sponsor Role lead

Responsible Party

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JOSE MANUEL SANCHEZ SAEZ

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jose Sanchez Saez, Podólogo

Role: PRINCIPAL_INVESTIGATOR

Universidade da Coruña

Locations

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Clínica López del Amo

Murcia, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 31208123 (View on PubMed)

Other Identifiers

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1402201803718

Identifier Type: -

Identifier Source: org_study_id

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