NIH Release/Relock Socket
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Limb Volume
研究概览
简要总结
The goal of the research is to create and evaluate a new technology for management of daily residual limb fluid volume fluctuation.
详细描述
Limb fluid volume changes that can occur in the residual limb of a lower-limb amputee can result in changes in socket fit that lead to discomfort, skin injuries, and reduced mobility. It is known that limb fluid volume fluctuations can be reduced for some people by intermittently removing (doffing) the socket throughout the day. It is believed that partially doffing the socket may have a similar benefit, and could be made more convenient thereby promoting easier compliance for prosthetic users.
The goal of the research is to create and evaluate a new technology for management of daily residual limb fluid volume fluctuation. The technology enables partial doffing through the release and relock of a socket panel and the prosthetic pin used to hold the limb in place. The expected outcomes are an enhanced understanding of how socket adjustments after activity facilitate limb fluid volume recovery, subsequent fluid retention, and improved socket fit.
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
- •Had trans-tibial amputation at least 18 months prior to enrollment
- •Regularly wear a definitive prosthesis for at least 7 hours per week
- •Have a residual limb length of at least 9 cm
- •K2 or higher MFCL
- •Able to walk continuously with a prosthesis for at least 2 minutes at a time
- •Sit, stand, and negotiate a step of 5.0 cm
- •Participants involved remotely will have to meet the following inclusion criteria:
- •Have a spare prosthesis
- •No cognitive issues
- •Good hand dexterity and strength (not frail)
- •Capable of communication over a video Zoom conference call.
排除标准
- •Current presence of skin breakdown
- •Unable to satisfy inclusion criteria
结局指标
主要结局
Change in Limb Volume
时间窗: Change from baseline period (no release/relock) to test period (release/relock), commonly each 1 hour long and separated by a seated period of approximately 30 minutes
Limb volume fluctuations will be measured in real-time as socket release/relock strategies are tested. This will be accomplished using a portable bioimpedance device with thin sticky electrodes that are placed on the residual limb. Specifically, the change in limb volume will be assessed from a baseline period where no socket adjustments are made to another period within the same test session where socket adjustments are made.
Prosthesis Evaluation Questionnaire (PEQ)
时间窗: Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments.
Participants will be asked to fill out a questionnaire related to their experience using the test socket out of lab in various test configurations. Each question on the PEQ can receive a score form 0 to 100, with higher scores indicating greater satisfaction.
PROMIS-Fatigue
时间窗: Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments.
Participants will be asked to fill out a questionnaire related to their experience using the test socket out of lab in various test configurations. Each PROMIS-Fatigue question asks participants to rank on a scale from 1 to 5 (categorical options), with higher scores indicating greater level of fatigue.
Socket Comfort Score (SCS)
时间窗: Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments.
Participants will be asked to rank their comfort while using the test socket out of lab in various test configurations. The SCS ranges from 0 to 10 (categorical), with higher scores indicating greater level of comfort.
次要结局
未报告次要终点
研究者
Joan Sanders
Professor, Department of Bioengineering
University of Washington