Characterizing the Effects of the X10D Sole on Walking Behavior in Healthy Subjects
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
- CoP path during ankle-foot roll-over movement as measured by pressure plates integrated in the treadmill
研究概览
简要总结
The aim of this study is to characterize the biomechanical effects of the X10D sole using objective, quantitative measurement methods.
The walking pattern of many people is becoming increasingly passive, and the muscles of the feet and legs are getting weaker. The X10D shoe is an adapted shoe designed to make walking more active and dynamic again.
This study investigates the detailed biomechanical effects of the X10D shoe on the walking pattern of healthy participants. For this purpose, walking with the X10D shoe will be compared with (1) walking in a control shoe with a neutral sole and (2) walking in the participants' everyday sports shoes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The inclusion criteria are:
- •Healthy subjects aged 50-65 years
- •Ability to walk at minimum 30 minutes at a regular pace without assistance or breaks
- •Written informed consent as documented by signature (see informed consent form)
排除标准
- •The exclusion criteria are:
- •Women who are pregnant or breast feeding
- •Current neurological problems affecting walking function and balance
- •Current orthopedic problems affecting upper and lower extremity movements
- •History of alcohol abuse or the intake of psychotropic drugs
- •History of major cardiac condition (e.g., infarction, insufficiency (NYHA II-IV))
- •History of major pulmonary condition (e.g., chronic obstructive pulmonary disease (GOLD II-IV))
- •Current major depression or psychosis
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia
- •Fever of unknown origin
研究组 & 干预措施
Interventional shoe
干预措施: X10D shoe (Device)
结局指标
主要结局
CoP path during ankle-foot roll-over movement as measured by pressure plates integrated in the treadmill
时间窗: up to 4 weeks
次要结局
未报告次要终点