Effect of a Newly Developed Brace on Foot Biomechanics: An in Vivo Interventional Study With Dynamic Computed Tomography.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Longitudinal Arch Angle (LAA)
研究概览
简要总结
For this interventional study the investigators will recruit a number of healthy volunteers with no symptoms in their lower limbs in the past 6 months and without history of foot and/or ankle conditions and/or surgery. These volunteers will undergo a single Dynamic Computerized Tomography scan session before and after the support is carried, to find out if there is a change in the kinematics of the foot. The results will be analyzed statistically.
详细描述
For this study the investigators will recruit 15 healthy volunteers who will be undergone a single Dynamic Computed Tomography (4DCT) scanning session before and after wearing a brace, in order to find out if there is a change in foot kinematics. Between the two scans, the subjects will wear the brace and walk for 1 minute. Data collected with the 4DCT will be processed to get 3D imaging of the Subtalar and Midtarsal Joints, needed to quantify the rotations in the three planes of the space (Cardan Angles).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers;
- •18<Age<60;
- •No gender restrictions;
排除标准
- •Symptoms in their lower limbs in the past 6 months
- •History of foot and/or ankle conditions and/or surgery
- •Pregnancy
结局指标
主要结局
Longitudinal Arch Angle (LAA)
时间窗: 1 Day
The Longitudinal Arch Angle (LAA) is a static measurement and is the angle defined by two vectors: the first vector passing through the midpoint of the medial malleolus to the navicular tuberosity; the second passing through the midpoint of the medial aspect of the first metatarsal head to the navicular tuberosity. The value of the LAA allowed us to identify the type of foot in one of these three categories: with LAA less than 130° is considered a pronated foot posture; with a LAA between 130° and 150° is considered a typical foot structures; with LAA greater than 150° is considered a supinated foot.
次要结局
未报告次要终点
研究者
Scafoglieri Aldo
Professor
Vrije Universiteit Brussel