Biomechanical Characterisation of 3D Printed Comfort Insoles
Biomechanical and Satisfaction Analysis of 3D Printed Comfort Insoles
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Baranya
-
Pécs、Baranya、匈牙利、7624
- University of Pecs
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- age between 18 and 65 years, able to walk independently, with no significant cognitive deficit which may limit the cooperation, willing to use the insole for 3 weeks, 3 hours daily and signed informed consent
Exclusion Criteria:
- pregnancy during the study period, any neurologic deficit or trauma related pathology likely to alter normal gait, and any sores or injuries distal to the ankle joint
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:治疗
|
3D printed comfort insole
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Likert based satisfaction analysis
大体时间:3 weeks
|
12 item 5 point Likert scale Q1. The insole is comfortable for wearing in my regular shoes, even for all-day wear Q2. The insole is comfortable for wearing in my regular shoes, for 1-2 hours maximum Q3. I am satisfied with the appearance of my insoles Q4. The design of the insole is suitable (it fits my foot size and my foot shape) Q5. My new insoles are more comfortable than my previous insoles Q6. I would recommend this technology and the insole to others Q7. My pain has been reduced by wearing insoles Q8. The insole did not move/slip when placed in my shoe during wear Q9. Insole comfort was unaffected by foot perspiration Q10. I am satisfied with the time it took to make the insoles (including sampling, production and delivery) Q11. The insoles did not damage my shoes Q12. Regardless of the study, I will use the insoles in the future |
3 weeks
|
|
temporal-spatial gait parameters
大体时间:3 weeks
|
Pedogait system (plantar pressure & gait analysis): - temporal-spatial gait: step length, stride length, center of pressure trajectory in cms |
3 weeks
|
|
gait timing measures
大体时间:3 weeks
|
stride time, walking phase durations: stance-, swing time, single/double support contact time and timing of heel strike in seconds (s)
|
3 weeks
|
|
pressure distribution parameters
大体时间:3 weeks
|
peak plantar pressure by region (heel, midfoot, forefoot, toes), pressure distribution by foot region in Newton (N)
|
3 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
spinal and postural assessment
大体时间:3 weeks
|
Diers Formetric 4D (surface topography / spinal posture): 3D surface topography of the back (no radiation)Trunk imbalance / lateral deviation Spinal curvature angles: thoracic kyphosis, lumbar lordosis, scoliosis-related measures: vertebral lateral deviation, scoliosis angle / "Cobb equivalent", Vertebral rotation, hump height, pelvic parameters: pelvic inclination, pelvic torsion, Sagittal and coronal vertical balance, shoulder imbalance, symmetry indices and change over time, knee flexion, ankle flexion, in degrees (°)
|
3 weeks
|
合作者和调查者
调查人员
- 首席研究员:Luca Tóth, M.D PhD、University of Pécs Neurosurgery Clinic
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 16779-6/2024
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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