A Comparative Assessment of Conventional and Adjustable Transfemoral Prosthetic Sockets
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Socket Fit Comfort Score
研究概览
简要总结
The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making.
详细描述
The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making. The investigators will explore a range of outcomes that have been found to be important for prostheses users and specifically assess the claims made by device manufacturers. Thirty adults with a transfemoral amputation will participate in four test sessions; one with their clinically prescribed, laminated socket, and three with different adjustable sockets. This data will be used to test the following aims: 1) does socket design impact socket comfort and prosthetic satisfaction? 2) does socket design impact of prosthetic socket on patient mobility and confidence, 3) how does prosthetic socket design influences prosthetic use in the home?, and 4) Are individual characteristics associated with benefits of specific socket designs?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Unilateral lower-limb amputation
- •Six months of independent ambulation
- •Own and regularly wear a prosthesis with socket
- •Minimum functional level of K2 on the Medicare Functional Classification Level (MFCL): corresponding to "the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces. Typical of the limited community ambulator"
排除标准
- •Pathology or injury of the intact limb
- •Medication that affects their ability to walk
- •Neurologic or cardiovascular disease
- •Significant vision problems
- •Suffer from an impaired mental capacity that negatively impacts verbal communication with the clinicians and research team, or requires a Legally Authorized Representative to facilitate communication
结局指标
主要结局
Socket Fit Comfort Score
时间窗: After at least 3 weeks of prosthetic socket use
The Socket Fit Comfort Score (SCS) is a single question in which subjects are asks: "On a scale from 0-10, if 0 represents the most uncomfortable socket fit you can imagine and 10 represents the most comfortable socket fit, how would you score the comfort of the socket fit of your artificial limb at the moment?"
Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ)
时间窗: After at least 3 weeks of prosthetic socket use
The PEQ consists of 82 items of which 41 items form nine subscales concerning Prosthesis Utility (UT), Residual Limb Health (RL), Appearance (AP), Sounds (SO), Ambulation (AM), Perceived Response (PR), Frustration (FR), Social Burden (SB), and Well-Being (WB). The remaining 41 items are analyzed as single items. These items are scored on a 100-mm visual analog scale with descriptors at the extremes (e.g. never and all the time). The scales are calculated as averages of the items on a metric from 0 to 100 with higher scores indicating better health.
Activities Specific Balance Confidence Scale
时间窗: After at least 3 weeks of prosthetic socket use
The ABC scale is a 16-item self-reported measure scored on a rating scale from 0 to 100, with higher scores indicate greater balance confidence. An average score is calculated by adding all item scores and dividing by the total number of items. The ABC scale has demonstrate high internal consistency, good test-retest validity, and good construct validity in people with lower limb amputation.
Mobility as Measured by the 10-meter Walk Test
时间窗: after at least 4 weeks of prosthetic socket use
The 10-m walk test measures elapsed time over 10 m from a standing start. Participants complete one practice trial and then two test trials. The outcome is the average speed walked during the two trials.
Mobility as Measured by Timed Up and Go (TUG)
时间窗: after at least 4 weeks of prosthetic socket use
The timed-up-and-go (TUG) assesses several aspects of mobility including getting out of a chair, walking 3 m, turning, and sitting down (Schoppen et al. 1999). The outcome is the time from buttocks off the chair to buttocks down. The best of three trials was recorded.
Mobility as Measured by Five Times Sit To Stand (FTSTS)
时间窗: after at least 4 weeks of prosthetic socket use
FTSTS is a measure of functional mobility, lower limb strength, and dynamic balance.
Self-reported Mobility Using the Prosthetic Limb Users Survey of Mobility (PLUMS-M) 12-item Short Form
时间窗: After at least 3 weeks of prosthetic socket use
The PLUS-M 12-item short form assess self-reported mobility. The questions are summed and the score is converted to a T-Score (e.g. 50 indicates the population mean with a standard deviation of 10). Values higher than 50 indicate self-reported mobility better than the average person with lower limb amputation, while those less than 50 are below the average.
次要结局
- Prosthetic Wear Time(After at least 3 weeks of prosthetic socket use)
- Time to Complete the L Test(After 4 weeks of prosthetic socket use)
- Steps Per Day Taken at Home(After three weeks of device use)
- Prosthetic Preference(After at least three weeks of prosthetic socket use.)
研究者
Deanna H Gates
Associate Professor
University of Michigan