Evaluation of the Static Stability of Footwear (EEECS)
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:
Visão geral do estudo
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Murcia, Espanha, 30008
- Clínica López del Amo
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: 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.
|
To evaluate the static balance of subjects when barefoot and when using three types of footwear with their eyes closed or open.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Stroke length
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jose Sanchez Saez, Podólogo, Universidade da Coruña
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 1402201803718
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Postural; Variedade
-
Duke UniversityRecrutamentoBem-estar dos cuidadores (Caregiver Strain Index)Estados Unidos
-
Bezmialem Vakif UniversityConcluídoDistúrbios da marcha em crianças | Equilíbrio | Estabilidade postural | Controle Postural | Anteversão FemoralPeru
-
Kafrelsheikh UniversityConcluído
-
Baltimore VA Medical CenterConcluídoEquilíbrio posturalEstados Unidos
-
Escoles Universitaries GimbernatConcluído
-
Liberty UniversityNational Academy of Sports MedicineConcluídoPostural; DefeitoEstados Unidos
-
University of LausanneConcluídoControle PosturalSuíça
-
East Tennessee State UniversityConcluídoEquilíbrio posturalEstados Unidos
-
University Hospital HeidelbergConcluído
-
University of Novi SadConcluído