NCT03662399已完成不适用
A Single Centre, Cross-over Study to Evaluate the Effect of a Range of Pre-formed Orthoses on Function of the Foot and Leg to Generate Technical Data on How the Individual Insoles Impact Gait, Distribution of Load and Stability in a Healthy Population.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
研究概览
简要总结
This study aims to evaluate the effect of a range of pre-formed orthoses on function of the foot and leg to generate technical data on how the individual insoles impact gait, distribution of load and stability in a healthy population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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 male and female subjects between the ages of 18-60 years inclusive.
- •Subjects who are able to give written informed consent.
- •Subjects who are able to understand the study, cooperate with the study procedures and are able to attend all study assessments.
- •Subjects who are willing to wear a t-shirt and shorts during the study assessments.
- •Subjects who are willing and able to stand for a minimum of two hours at a time during the study assessments.
- •Subject with shoe size between 4.5 to 11 (UK) / 37 to 45 (European).
- •Subjects who can achieve the acceptable fit of standard shoes.
- •Subjects who do not have any walking impairments and can walk without distress. This will be determined through walking at a speed of 3-5 kmph for a distance of 30 m.
- •Subjects with a Foot Posture Index (FPI) between 6 and 9 showing mild pronation as determined by the study Investigator or designees.
- •Subjects with a BMI between 18.5 - 24.9 kg/m2.
排除标准
- •Subjects who are pregnant or who have given birth within the last 6 months.
- •Subjects who have a medical condition that could compromise the use of the orthotic insoles (peripheral vascular disease or sensory neuropathy).
- •Subjects that have Leg Length Discrepancy (LLD) of more than 5 mm. This will be determined using the Downings Sign (7), a test which is used to establish actual versus functional LLD. This will be cross-referenced with anatomical land marks.
- •Subjects that use prescribed or self-administrated orthotics to correct biomechanical or other issues.
- •Subject that have received any previous orthotic treatment.
- •Subjects who have a current or previous injury that has prevented their usual activities for more than 3 weeks in the last year.
- •Subjects with history of lower limb or foot surgery, inflammatory disease, neurological disease, diabetes, leg ulceration, skin grafts or any other condition that in the opinion of the Investigator or designees could interfere with the assessments in this study.
- •Subjects having ischemia or poor blood supply to the feet, Charcot Arthropathy, autoimmune disease (e.g. rheumatoid arthritis) and connective tissue disease (e.g. scleroderma).
- •Subjects demonstrating symptoms of macrovascular diseases (e.g. angina, stroke).
- •Individuals suffering from other conditions affecting the feet, such as infectious foot conditions, which in the opinion of the Investigator or designees, would interfere with the generation of data and risk the spread of infection to other subjects through the use of the standard shoe.
- •Individuals with broken/irritated or damaged skin on their feet.
- •Individuals suffering from relevant product allergies or sensitivities.
- •Individuals who have consulted a healthcare professional for a gait related or foot pain issue.
- •Individuals who were previously in another clinical study within the last 3 months prior to screening assessment.
- •Employees who are directly involved with the study at study site.
- •Any partner or first degree relative of anyone that has a role in the study at the CRO/Site/Sponsor.
研究组 & 干预措施
Insole A
Experimental
Investigational product - Insole A
干预措施: Insoles (Device)
Insole B
Experimental
Investigational product - Insole B
干预措施: Insoles (Device)
Insole C
Experimental
Investigational product - Insole C
干预措施: Insoles (Device)
Insole D
Experimental
Investigational product - Insole D
干预措施: Insoles (Device)
Insole E
Experimental
Investigational product - Insole E
干预措施: Insoles (Device)
Insole F
Experimental
Investigational product - Insole F
干预措施: Insoles (Device)
Insole G
Experimental
Non-Investigational product - Standard shoe
干预措施: Standard shoe (Other)
结局指标
主要结局
In shoe dynamic pressure (shock absorption and loading pattern) Impact on Gait
时间窗: 2 hours
Peak pressure (PP)
3D gait analysis
时间窗: 2 hours
Rearfoot angle at contact
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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