Qualitative & Quantitative Comparison of Hydrostatic vs Vacuum Casting Methods in Trans-Tibial Amputees
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Six-Minute Walk Test
研究概览
简要总结
The purpose of this graduate research study is to compare hydrostatic and vacuum casting techniques using patient mobility indicators, volume displacement, comfort, and overall satisfaction outcomes in trans-tibial amputees.
详细描述
Visit 1
- Informed Consent
- Subject will be casted using both the hydrostatic and vacuum system techniques
Visit 2 (7-10 days after Visit 1)
- One of two sockets will be randomly assigned and fitted/aligned by investigators
- Subject will be asked to perform a Timed Up and Go Test followed by a Six-Minute Walk Test
- Subject will fill out a comfort questionnaire for the prosthesis worn
Visit 3 (7 to 10 days after Visit 2)
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
- 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
- 是
入选标准
- •18 years of age or older
- •Trans-tibial amputation, unilateral
- •Able to walk for a six-minute minimum w/o a break
- •Amputation history of at least 6 months
排除标准
- •Syme amputation
- •Physical disability or injury affecting a natural gait pattern
- •Ulcers or blisters on the residual limb
研究组 & 干预措施
vacuum casting
Vacuum casting will be performed using the Ottobock vacuum casting system. For our vacuum casting procedures, we will be following the protocols outlined in the Harmony Fabrication Quick Guide
干预措施: vacuum casting (Other)
hydrostatic casting
For the aqua casting system, we will be using an in-house manufactured device. This device will be created following guidelines from the PCAST Technical Manual
干预措施: hydrostatic casting (Other)
结局指标
主要结局
Six-Minute Walk Test
时间窗: between 7-10- days after study enrollment
Participants will walk in a 100-ft hallway on a flat, hard surface in a period of 6 minutes.
次要结局
- Six-Minute Walk Test(between 14-20 days after study enrollment)
- Volume Calculation(between 14-20 days after study enrollment)
- Volume Calculation(between 7-10- days after study enrollment)
研究者
Heather Appling
Assistant Professor
Loma Linda University