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Evaluation of the Static Stability of Footwear (EEECS)

4. januar 2019 opdateret af: JOSE MANUEL SANCHEZ SAEZ

Evaluation of the Static Stability of Footwear: A Clinical Trial

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:

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

26

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
      • Murcia, Spanien, 30008
        • Clínica López del Amo

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

25 år til 35 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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.
Enhed: Stabilometry
To evaluate the static balance of subjects when barefoot and when using three types of footwear with their eyes closed or open.
Andre navne:
  • Eyes open and eyes closed

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stroke length
Tidsramme: 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
30 seconds
Stroke surface
Tidsramme: 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
30 seconds
Relationship between Length / surface
Tidsramme: 30 seconds

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
Tidsramme: 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
30 seconds
Lateral velocity
Tidsramme: 30 seconds
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
Tidsramme: 30 seconds
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
Tidsramme: 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
30 seconds
Average displacement on the Y axis
Tidsramme: 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
30 seconds

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

JOSE MANUEL SANCHEZ SAEZ

Efterforskere

  • Ledende efterforsker: Jose Sanchez Saez, Podólogo, Universidade da Coruña

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. december 2018

Primær færdiggørelse (Faktiske)

30. december 2018

Studieafslutning (Faktiske)

4. januar 2019

Datoer for studieregistrering

Først indsendt

27. november 2018

Først indsendt, der opfyldte QC-kriterier

2. december 2018

Først opslået (Faktiske)

5. december 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. januar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. januar 2019

Sidst verificeret

1. januar 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 1402201803718

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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