Evaluation of the Static Stability of Footwear: A Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Relationship between Length / surface
研究概览
简要总结
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:
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Stabilometry (Device)
结局指标
主要结局
Relationship between Length / surface
时间窗: 30 seconds
Value resulting from the relationship between the two previous measures. The Podoprint pressure platform was used as a measuring device. Quantitative variable
Lateral velocity
时间窗: 30 seconds
Average speed of oscillation in its axis of ordinates. The Podoprint pressure platform was used as a measuring device. Quantitative variable
Average displacement in the X axis
时间窗: 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
Stroke length
时间窗: 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
Average displacement on the Y axis
时间窗: 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
Stroke surface
时间窗: 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
Average swing speed
时间窗: 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
Forward speed
时间窗: 30 seconds
Average oscillation speed on its abscissa axis. The Podoprint pressure platform was used as a measuring device. Quantitative variable
次要结局
未报告次要终点
研究者
JOSE MANUEL SANCHEZ SAEZ
Principal investigator
Universidade da Coruña