Impact of Improving Footwear Options for Women Veterans With Amputations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Amputation-Specific Body Image Scale-Revised (ABIS-R) Change
研究概览
简要总结
Veterans with leg amputations have limited footwear options because their artificial feet do not change shapes for different shoes. Studies have shown that women with amputations receive more frequent prosthetics care than men, but are less satisfied with the fit, comfort, and appearance of their prostheses. The investigators' previous research indicates that women Veterans would like to be able to wear a broader variety of footwear, and those who perceive more footwear limitations tend to have poorer body image and community participation. A new prosthesis designed by the investigators' group allows Veterans with amputations to use their footwear of choice using 3D-printed artificial feet with a single ankle. The novel prosthesis will be tested in this project with women Veterans with amputations to determine the impact of improving footwear options on body image and community participation.
详细描述
Background - Veterans with leg amputations have limited footwear options because their artificial feet do not change shapes for different shoes. Studies have shown that women with amputations receive more frequent prosthetics care than men, but are less satisfied with the fit, comfort, and appearance of their prostheses. The investigators' previous research indicates that women Veterans would like to be able to wear a broader variety of footwear, and those who perceive more footwear limitations tend to have poorer body image and community participation. A new prosthesis designed by the investigators' group allows Veterans with amputations to use their footwear of choice using 3D-printed artificial feet with a single ankle. The investigators seek to understand the impact of improving footwear options for women Veterans with amputations on body image and community participation following a 6-month take-home trial.
Research Questions (Objectives) - The purpose of this project is to evaluate the effect of a new prosthetic ankle-feet system on body image and participation among women Veterans with lower limb amputations.
Relevance to VA - Women Veterans with amputations is a small but growing demographic of US military Veterans. Women with amputations receive more frequent prosthetics care, but are less satisfied with the fit, comfort, and appearance of their prostheses than men. These findings are not surprising as most prosthesis components are not gender-specific and seem to have been designed for men. The investigators' group has developed a 3D-printed ankle feet system customized to fit a wide range of footwear, including shoes of different heel heights and widths. This new prosthesis system dramatically improves footwear options for persons using leg prostheses, enabling potential to increase body image and community participation for women Veterans with leg amputations. This study is an important next step in the investigators' line of research and is needed to determine the impact of improving footwear options for this important and growing subpopulation of Veterans.
Number of Research Participants (Sample Size) - We will recruit up to 18 women Veterans with transtibial amputations to participate and anticipate that at least 12 participants will complete the entire study. The investigators plan to screen women Veterans from a national sample to accomplish the recruitment and completion goals.
Participating Sites - Minneapolis VA Health Care System
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •US military Veterans that identify as women
- •Transtibial (below-knee) amputation
- •Using a definitive prosthesis for at least 6 months (limb has accommodated to prosthesis use post-amputation)
- •Well fitting and well aligned prosthesis
- •Blessed Orientation-Memory-Concentration (Short Blessed) score between 0-6
- •Access to computer, tablet, or smart phone and internet for video conferencing and RedCap data collection
排除标准
- •Residual limb skin problems
- •Residual limb too long to accommodate the RECOVER prosthetic ankle-feet system
- •Unable or unwilling to travel to Minneapolis
- •Not a regular prosthesis user
- •Mass over 125 kg
- •Documented neurocognitive disorder (e.g., dementia) with evidence of impact on activities of daily living and/or instrumental activities of daily living
- •Baseline ABIS-R or PROMIS-APSRA scores at the maximum levels (no room for improvement on primary outcomes)
结局指标
主要结局
Amputation-Specific Body Image Scale-Revised (ABIS-R) Change
时间窗: Baseline, 1-month, 6-months
The ABIS-R is a 14-item scale that assesses body image disturbance among individuals with amputations. Responses are reported on a 1 to 3 scale, with higher values representing greater body image disturbance.
PROMIS Ability to Participate in Social Roles and Activities (PROMIS APSRA) Change
时间窗: Baseline, 1-month, 6-months
The PROMIS Ability to Participate in Social Roles and Activities (PROMIS-APSRA) specifically measures one's ability to participate in social roles and activities, including one's ability to do leisure activities and activities with friends and family. The PROMISAPSRA is an 8-item form that uses a 5-point scale, where higher values indicate a higher degree of ability to participate.
次要结局
未报告次要终点