Villency - Proof of Action: Foot Device, Balance and Sway, Kinematics of Walking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Center of Peak Speed of Displacement.
研究概览
简要总结
This study involves the use of a newly designed shoe insole device (also referred to as a foot insole device) similar to various shoe insoles or inserts you can buy at a store or pharmacy.
详细描述
This study involves the use of a newly designed shoe insole device (also referred to as a foot insole device) similar to various shoe insoles or inserts you can buy at a store or pharmacy. Healthy participants will wear this insole device in their own athletic/tennis shoes over the course of one week. There are two key purposes of this study: 1. To determine how using this insole device for 1 week may effect a healthy individual's balance and postural sway while standing; and 2. To determine how using this insole device for 1 week may effect how an individual walks (gait), how hard they hit the ground as they walk, and foot pressure patterns with each step. Each individual's balance, postural sway, and walking gait (how you walk) will be analyzed before and after wearing the shoe insole device for the one-week time period.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •● Willing to maintain current level of physical activity during the study period of a week (no increase or decrease of activity level).
排除标准
- •Moderate or severe obesity (body mass index >35kg/m2)
- •Known diagnosis of cardiovascular, orthopaedic, or neurological conditions, uncontrolled diabetes, or any condition that impacts normal walking ability
- •Any current ankle, knee, hip or low back pain
- •Currently using any knee or ankle brace on a regular basis for joint pains
- •Severe back pain, prior spinal fusion or spinal deformity that would affect gait
- •Major cardiac or pulmonary conditions and any orthopedic limitation that precludes their ability to independently walk for 10 minutes or longer
- •Any major orthopedic injury within the prior 12 months
研究组 & 干预措施
Healthy men and women
Participants will serve as their own control. Balance and gait measures will be collected during an initial visit and after one week of using the experimental foot device
干预措施: experimental foot device (Device)
结局指标
主要结局
Center of Peak Speed of Displacement.
时间窗: At 1 week of acclimation
Two-foot stance, Single foot balance, and Tandem stance- and the peak speed of displacement (cm per second) will be determined.
Center of Mass Displacement (Sway) During Standing
时间窗: At 1 week of acclimation
Two-foot stance, Single foot balance, and Tandem stance- Once the data are collected, calculations of center of mass displacement (in cm) will be determined. These values will provide insight about direction of sway and how quickly sway occurs during these three balance conditions.
Center of Variability Displacement During Standing
时间窗: At 1 week of acclimation
Two-foot stance, Single foot balance, and Tandem stance- the variability of displacement and area (cm2) will be determined
次要结局
未报告次要终点