Exploratory Testing of a Pediatric Foot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 主要终点
- Overall Prosthetic Foot Stiffness
研究概览
简要总结
The purpose of the following study is of exploratory nature to provide design input for a prosthetic foot under development for children with lower limb loss, amputation or deficiency.
详细描述
The purpose of the following study is of exploratory nature to provide design input for a prosthetic foot under development for children with lower limb loss, amputation or deficiency.
User testing is needed to get data points for the stiffness curve of the foot. These datapoints are extrapolated from user testing and reduces the risk to design a too stiff or soft device.
Machine tests cannot replace user feedback. The user´s perception helps to detect performance deficits and address these in early stages of the design.
Walking performance may change if the foot is too stiff or too soft. Some of these changes can be spotted by observation through legal guardians or experienced prosthetists. Product changes may be justified based on the observations made by the child, legal guardian, Certified Prosthetist/Orthotist (CPO) or engineers specializing in foot design.
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
- 5 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cognitive ability to understand all instructions and questionnaires in the study (adapted to kids).
- •Active prosthesis user
- •Transtibial or transfemoral amputation, limb loss or similar level congenital limb deficiency.
- •Age 5 or older.
- •o Age 5-12 years preferred.
- •15 kg < Body weight < 55 kg
- •16 ≤ Foot size ≤ 24
- •Clearance: Size 16 > 50mm, Sizes 17-19 > 60mm, Sizes 20-24 > 70mm
- •Willing and able to participate in the study and follow the protocol, including consent to participate from legal guardian if under 16 years old.
排除标准
- •Users with severe residual limb pain or socket problems, which have negative impact on testing and outcome.
研究组 & 干预措施
Prosthetic Foot - Stiffness Testing
Test prosthetic feet with different stiffness properties.
干预措施: Prosthetic Foot (Device)
结局指标
主要结局
Overall Prosthetic Foot Stiffness
时间窗: 2 hours
User perception of provided prosthetic foot stiffness. Too soft good Too stiff
次要结局
- Overall Prosthetic Foot Performance(2 hours)