Digital Weight Bearing Shape Capture Socket Technology to Preserve Limb Health and Improve Rehabilitation Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Trans-Epidermal Water Loss (TEWL)
研究概览
简要总结
The study will determine if Symphonie Aqua Digital System, a new method of socket creation, in a weight-bearing environment, may produce more successful fitting and comfortability & functional outcomes than traditional sockets (non-weight bearing scanning). Additionally, the study will determine if a well-fitting socket will positively impact the overall health of amputee residual limb.
详细描述
This study will compare the use of Symphonie Aqua Digital System, which is a new way to create a socket for prosthetics, to the current method that is generally used to create sockets. The study will look at the differences in comfort and fit between the Symphonie Aqua Digital System and the current standard of care (SOC).
The study will determine if Symphonie Aqua Digital System, a new method of socket creation, in a weight-bearing environment, may produce more successful fitting and comfortability & functional outcomes than traditional sockets (non-weight bearing scanning). Additionally, the study will determine if a well-fitting socket will positively impact the overall health of amputee residual limb.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- •Ages 18 and above
- •Unilateral trans-tibial amputees
- •Ambulate at a K3 level or higher
- •At least 3 months post-amputation per physician discretion
- •Trans-tibial limb length greater than 4.5 inches in length
- •Able to follow directions and independently give informed consent
- •Must be able to ambulate without assistance
排除标准
- •Age < 18 years
- •Conditions that prevent wearing a prosthetic socket
- •Soc Socket made with weight bearing system
- •Cognitive deficits or mental health problems that would limit ability to consent and participate fully in the study protocol
- •Women who are pregnant or who plan to become pregnant in the near future
- •Weight > 280 lbs
研究组 & 干预措施
Symphonie Aqua System - Non-Digital (Socket B)
A digital weight bearing test socket where shape capturing is done in full weight bearing
干预措施: Symphonie Aqua Digital System mediated sh (Device)
Standard of Care (SoC)
This is standard of care socket design where sockets are fabricated in non-weight bearing position
干预措施: Symphonie Aqua Digital System mediated sh (Device)
结局指标
主要结局
Trans-Epidermal Water Loss (TEWL)
时间窗: 6 weeks
Differences between two systems and effects on Trans-Epidermal Water Loss (TEWL) will be measured by placing a non-invasive probe on the surface of the skin. Each measurement takes approximately 7-30 seconds each. The data is presented as g x m\^-2xh\^-1. Higher number indicates worse outcome.
次要结局
- Laser Speckle Imaging (LSI)(6-weeks)
- In-socket Pressure(6-weeks)
- Mobility (6MWT)(6-weeks)
- Balance During Ambulation (TUG)(6-weeks)
研究者
Dr. Sashwati Roy
Professor of Surgery
Indiana University