Prosthetic Socket Interface Design on Socket Comfort, Residual Limb Health, and Function for the Transfemoral Amputee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Skin Temperature
研究概览
简要总结
The primary objective of this clinical trial is to determine if the Dynamic Socket and Sub-Ischial alternative interface designs improve socket comfort, residual limb health, increase function and be preferred over the standard of care Ischial Ramus Containment (IRC) interface for the military and veteran living with transfemoral limb loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral above the knee amputees of non-dysvascular etiology
- •100-275 lbs
- •≥ 1 yr. of prosthetic experience
- •Independent community ambulator
- •Self-reported ability to walk for 20min consecutively
排除标准
- •Above the knee amputees of dysvascular etiologies
- •Body weight <100 or >275 lbs
- •Does not speak English or Spanish
- •Use of an assistive device (i.e. canes, walkers)
- •Transtibial, hip disarticulation, hemipelvectomy, partial foot and bilateral amputees
- •Known skin issues
- •Known cognitive impairment
研究组 & 干预措施
Socket 1 (Ischial Ramus Containment)
This arm included unilateral transfemoral amputees who were assessed while using the Ischial Ramus Containment socket.
干预措施: Ischial Ramus Containment (IRC) (Device)
Socket 2 (Dynamic Socket IRC)
This arm included unilateral transfemoral amputees who were assessed while using the Dynamic Socket Ischial Ramus Containment socket.
干预措施: Dynamic Socket Ischial Ramus Containment (IRC) (Device)
Socket 3 (Sub-Ischial Interface)
This arm included unilateral transfemoral amputees who were assessed while using the Sub-Ischial Interface socket.
干预措施: Sub-Ischial Interface (Sub-I) (Device)
结局指标
主要结局
Skin Temperature
时间窗: Accommodation with new prosthetic sockets is approximately 10 days
Continuous skin temperature measurement (Celsius) will be taken during treadmill walking at self-selected comfortable speed
Perspiration
时间窗: Accommodation with new prosthetic sockets is approximately 10 days
Perspiration will be measured by tare weight (grams) following treadmill walking.
Vertical Interface Movement (Pistoning)
时间窗: Accommodation with new prosthetic sockets is approximately 10 days
Pistoning will be defined as the numerical difference of interface to skeletal movement (cm) between simulated swing (lifting the prosthetic side) and stance (single support on the prosthetic side) as measured by coronal X-Ray.
次要结局
- Comfort(Accommodation with new prosthetic sockets is approximately 10 days)
- Balance and Stability(Accommodation with new prosthetic sockets is approximately 10 days)
- Preference(Accommodation with new prosthetic sockets is approximately 10 days)