Investigating Auto Adjusting Dynamic AFO
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Longest Running Bout Duration
研究概览
简要总结
Offloading Ankle Foot Orthoses (AFOs) are devices designed for people following lower-limb reconstruction to restore mobility by reducing mechanical loading through the injury site and redistributing it proximally. While they perform well for some users, their current form limits full functional potential and may put joints proximal to the injury at risk of long-term damage. This study is directed toward designing and testing a lightweight, variable stiffness, dynamic brace that can adjust in response to user activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Longest Running Bout Duration
时间窗: Across all days of data collection (up to 4 weeks), the longest bout of continuous activity will be identified (minutes).
Collected while participant uses device in free-living environment.
Time Running Per Day
时间窗: Calculated across all days of data collection (up to 4 weeks).
Collected while participant uses device in free-living environment.
PROMIS-Fatigue
时间窗: Following their time out in their free-living environment (up to 4 weeks at a time), participants will be asked to complete a questionnaire related to fatigue.
Participants will be asked to fill out a questionnaire related to their experience using the variable stiffness AFO 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 a greater level of fatigue.
Pain Score
时间窗: Following their time out in their free-living environment (up to 4 weeks at a time), participants will be asked to complete a questionnaire related to pain.
Participants will be asked to fill out a questionnaire related to their experience using the variable stiffness AFO out of lab in various test configurations. Each Pain-Score question asks participants to rank on a scale from 1 to 10 (categorical options), with higher scores indicating a greater level of pain.
Orthotic Evaluation Questionnaire (OEQ)
时间窗: Following their time out in their free-living environment (up to 4 weeks at a time), participants will be asked to complete an OEQ.
Similar to the Prosthesis Evaluation Questionnaire (PEQ), the OEQ will ask various questions concerning their experience wearing the variable stiffness AFO. Participants will rate their overall satisfaction, ability to ambulate, the health of their limb, the utility of the device, and their overall well-being after wearing the device.
Running Speed on Treadmill
时间窗: In-lab testing will occur over the course of up to 2 hours at a time.
Participants carrying out the in-lab protocol will be asked to run using the variable stiffness AFO and running speed will be documented at various time points.
Extended Figure-of-8 Test
时间窗: In-lab testing wil occur over the course of up to 2 hours at a time.
Participants carrying out the in-lab protocol will be asked to do a Figure-of-8 test.
次要结局
未报告次要终点
研究者
Joan Sanders
Professor: Engineering
University of Washington