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Completed

NCT Number: NCT03764332

Evaluation of the Static Stability of Footwear

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:

Completed

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Key information

Conditions

Postural; Strain Sprains and Strains Wounds and Injuries

Age range

25 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica López del Amo

Murcia, 30008, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stabilometry

Device

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

Primary outcomes

  1. Stroke length

    Time frame: 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

  2. Stroke surface

    Time frame: 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

  3. Relationship between Length / surface

    Time frame: 30 seconds

    Value resulting from the relationship between the two previous measures. The Podoprint pressure platform was used as a measuring device.

    Quantitative variable

  4. Average swing speed

    Time frame: 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

  5. Lateral velocity

    Time frame: 30 seconds

    Average speed of oscillation in its axis of ordinates. The Podoprint pressure platform was used as a measuring device. Quantitative variable

  6. Forward speed

    Time frame: 30 seconds

    Average oscillation speed on its abscissa axis. The Podoprint pressure platform was used as a measuring device. Quantitative variable

  7. Average displacement in the X axis

    Time frame: 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

  8. Average displacement on the Y axis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

JOSE MANUEL SANCHEZ SAEZ

Other

Registry information

Official study title

Evaluation of the Static Stability of Footwear: A Clinical Trial

Acronym: EEECS

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Dec 5, 2018
Registry last updated
Jan 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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