NCT03764332

Brief 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:

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

December 7, 2018

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2019

Completed
Last Updated

January 7, 2019

Status Verified

January 1, 2019

Enrollment Period

23 days

First QC Date

November 27, 2018

Last Update Submit

January 4, 2019

Conditions

Postural; Strain

Keywords

FootwearBarefoot

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (1)

Stabilometry

OTHER

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

Interventions

StabilometryDEVICE

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

Also known as: Eyes open and eyes closed
Stabilometry

Eligibility Criteria

Age25 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica López del Amo

Murcia, 30008, Spain

Location

Related Publications (1)

  • 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.

    PMID: 31208123DERIVED

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Jose Sanchez Saez, Podólogo

    Universidade da Coruña

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 27, 2018

First Posted

December 5, 2018

Study Start

December 7, 2018

Primary Completion

December 30, 2018

Study Completion

January 4, 2019

Last Updated

January 7, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)