Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Prosthetic Comfort and Utility Questionnaire (Version 1)
研究概览
简要总结
iFIT Prosthetics, LLC® created and commercialized a modular, immediate fit, fully adjustable, prosthetic system suitable for mass production using high strength injection molded polymer materials. The aim of this project is to assess the design, user satisfaction and feasibility of this device. The investigators will be fitting transtibial and transfemoral amputees with the iFIT prosthetic system. Patients will wear the device for 2 weeks in order to compare the device to their own prosthetic (if they currently have one). They will report any device breakages or adverse events. They will also fill out a questionnaire to determine if the iFIT prosthetic is a feasible option for treating patients with limb loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •transtibial or transfemoral level of amputation
- •functional ambulator with or without a cane
- •six months or more since amputation.
排除标准
- •patient have skin ulcerations on the residual limb
- •have other central nervous system disorders such as strokes and brain injuries that interfere with safe ambulation and gait testing
- •severe phantom or limb pain
- •weight over 260 lbs
结局指标
主要结局
Prosthetic Comfort and Utility Questionnaire (Version 1)
时间窗: 2 weeks
This questionnaire is based off of the Prosthetic Evaluation Questionnaire; it involves questions taken from the original that focus on comfort, satisfaction and utility of a prosthetic socket. We used numeric values from 1 (Poor) through 5 (Excellent) for evaluation. This version featured seven questions for a total of 35 points possible and the lowest score being 7 (higher scores are better). Scores are reported as total with standard deviations.
Prosthetic Comfort and Utility Questionnaire (Version 2)
时间窗: 2 weeks
This questionnaire is based off of the Prosthetic Evaluation Questionnaire; it involves questions taken from the original that focus on comfort, satisfaction and utility of a prosthetic socket. We used numeric values from 1 (Poor) through 5 (Excellent) for evaluation. This version features fourteen questions for a total of 70 points total, with the lowest score being 14. Higher scores are better. Scores are reported as total with standard deviations.
Prosthetic Comfort and Utility Evaluation (Version 3)
时间窗: 2 weeks
This questionnaire is based off of the Prosthetic Evaluation Questionnaire; it involves questions taken from the original that focus on comfort, satisfaction and utility of a prosthetic socket. We used numeric values from 1 (Poor) through 5 (Excellent) for evaluation. This version features ten questions for a total of 50 points possible, with the lowest score being 10. Higher scores are better. Scores are reported as total with standard deviations.
次要结局
- Number of Participants With Device Related Adverse Events(2 weeks)
- Residual Limb Circumference Measurements to Internal Socket Diameter(Same Day)
- Gait Analysis - Limp Index(2 weeks)
- Gait Analysis - Stride Length(2 weeks)
- Gait Analysis Stance Phase(2 weeks)
- Gait Analysis- Walking Speed(two weeks)
- Gait Analysis - Double Support(2 weeks)
- Internal Socket Pressure(Two weeks)