Wear and Tear Evaluation of New Nike Sport Sole, an Accessory Attachable and Detachable to the Running Prosthesis Cheetah Xceed
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 主要终点
- Percentage of Wear and Tear of the Nike Sport Sole
研究概览
简要总结
Running Specific Feet are based on the original Flex-Foot design using the energy storage and release function as the main design feature. Running specific prosthetic feet are intended for running and jogging. They all have similar design features such as a C-shaped spring carbon fiber foot plate that absorbs and returns energy when load is applied deflecting the carbon. In order to accommodate the running pattern which does not show a double stance phase as compared to walking, the Running Specific products do not feature a heel spring but directly load the C-shape spring at initial contact. The Running Specific Feet are usually equipped with additional accessory parts such as a traction sole or spike pad for smoother and more natural rollover.
The investigational device, the Nike Sport Sole, is an accessory for the Cheetah Xceed running prosthetic foot. Cheetah Xceed has already been placed on market and bears a CE mark, but the Nike Sport Sole is an upgraded Nike Sole design and the objective of this clinical investigation is to evaluate the observed wear and tear of the soles after 6-8 week usage among other usability aspects.
详细描述
The primary objective of this study is to evaluate the observed wear and tear of the new Nike Sport Sole after 6-8 weeks usage among other usability aspects compared to subjects current prescribed running prosthesis/sole combination.
i) Recruitment Potential subjects will be identified from the customer base of the Local Principal Investigator (LPI). LPI evaluates, based on previous experience of interaction with and servicing of patients, if a potential participant is cognitively capable. If a potential participant fits the inclusion and exclusion criteria the LPI will contact them via telephone. During the telephone call the LPI will verify if they are interested in participating in a study. If interest is expressed at this point, they will answer some screening questions and if the eligibility criteria are met an appointment will be made for the clinical visit and signing of the ICF. Questions relating to the duration of the study, number of clinical visits required, and the investigational device will be answered.
Potential risk of participating in the investigation will be explained to the subject at this point to the candidate for enrolment.
The LPI will communicate to the study monitor the number of users he has identified that meet the inclusion criteria and are willing to participate.
ii) Test procedure There are two scheduled study events. At the initial visit, the first study event, for each subject a researcher qualified to obtain informed consent will seat the subject and proceed as described in chapter 13.8 Informed consent.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50Kg< body weight < 116Kg
- •K-level: K3 and K4
- •Amputation level: Unilateral, bilateral, Trans-tibial, trans-femoral
- •Currently using running prosthesis with the option to connect to the components the investigational device is compatible to
- •Minimum build height: Distance from ground to socket adapter needs to be 318 mm or more.
- •Comfortable and stable socket fit
- •Willing and able to participate in the study and follow the protocol
排除标准
- •50Kg> body weight > 116Kg
- •Users with socket problems
- •Users with cognitive impairment
- •Younger than 18 years old
研究组 & 干预措施
Wear and tear of new Nike Sport Sole
The investigational device, the Nike Sport Sole, is an accessory for the Cheetah Xceed running prosthetic foot. Cheetah Xceed has already been placed on market and bears a CE mark, but the Nike Sport Sole is an upgraded Nike Sole design and the objective of this clinical investigation is to evaluate the observed wear and tear of the soles after 6-8 week usage among other usability aspects.
干预措施: Nike Sport Sole (Device)
结局指标
主要结局
Percentage of Wear and Tear of the Nike Sport Sole
时间窗: 6-8 weeks
Visual inspection of wear and tear of the Nike Sport Sole using a custom Wear/Tear Scoring Sheet. The Wear/Tear Scoring Sheet is an ordinal rating scale designed to evaluate the physical condition and durability of different regions of the sole-mounted prosthetic product after use. Each item was rated on a 5-point scale (1 = severe wear/damage, 5 = no or minimal wear/damage). Higher scores indicate better product condition and less wear, while lower scores indicate greater wear or damage. Item scores were summed across all assessed regions, divided by the maximum possible total score, and multiplied by 100 to obtain a percentage score. Higher percentages indicate less wear and better overall product condition.
次要结局
未报告次要终点