Impact of a Prosthetic Foot With Adjustable Heel Height on Physical Appearance and Participation: a Randomized Crossover Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Prosthetic Evaluation Questionnaire - Appearance scale (PEQ-AP)
研究概览
简要总结
Most prosthetic feet have a fixed heel height, which requires users to always wear shoes with the same heel height. A fixed heel height is a significant constraint, whereas the ability to choose one's clothing freely is an important aspect of coping with a physical disability.
The Taleo Adjust is a prosthetic foot with a hydraulic ankle that allows the user to adjust the heel height from 0 to 7 cm, depending on the type of shoe worn.
This study aims to evaluate the impact of an adjustable-heel-height foot on physical appearance and participation.
详细描述
The amputation or absence of a lower limb affects both mobility and appearance, which can lead to restrictions in social, family, and professional participation. The choice of prosthetic components aims to compensate as effectively as possible for the functional and physical disability, in line with the patient's expectations and life plan.
The prosthetic foot is a key component of the prosthesis. Most feet have a fixed heel height-most often around 10 to 15 mm-which requires users to always wear shoes with the same heel height, since prosthetic alignment, essential for harmonious and safe walking, is set accordingly.
A fixed heel height is a significant constraint for many users who wish to wear different types of shoes for aesthetic reasons (e.g., city shoes or pumps for work or going out; flip-flops or flat ballet flats in summer), for safety reasons (e.g., boots for motorcycling or gardening), or to be able to walk barefoot (e.g., at home). The ability to choose one's clothing freely is an important aspect of coping with a physical disability.
The Taleo Adjust is an energy-storing and energy-returning prosthetic foot with a hydraulic ankle that allows the user to adjust the heel height from 0 to 7 cm, depending on the type of shoe worn. Thanks to this articulation, prosthetic alignment is preserved and walking quality is not compromised.
This study aims to evaluate the impact of an adjustable-heel-height foot on physical appearance and participation.
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
- 否
入选标准
- •Adult patient with a major lower limb amputation whose life project includes:
- •movement in buildings other than the home (ICF d4601),
- •movement outside the home and other buildings (ICF d4602),
- •and other specified activities related to movement in other various places (ICF d4608).
- •Patient who has been using an Enregy storage and Return (ESR) foot for at least 3 months
- •Patient who wishes to walk with shoes with different heel heights, and/or barefoot
排除标准
- •Patient with a high impact level (e.g.: sport)
- •Patient with hip disarticulation or equivalent
- •Patient with an unstabilised residual limb and/or an unsuitable socket
- •Patient who cannot be fitted with a Taleo Adjust foot due to the technical characteristics of the product (user weight greater than 115kg; required foot size <22 or >28; mounting height less than 118 mm)
- •Patient whose usual foot has a heel height adjustment system
- •Patient unavailable for the duration of the study and/or unable to understand the instructions and/or answer questionnaires in French
- •Patient already participating in another study
- •Patient in an emergency situation or pregnant woman
结局指标
主要结局
Prosthetic Evaluation Questionnaire - Appearance scale (PEQ-AP)
时间窗: 30 days
A 5-item self-reported measure of the appearance domain. The participant rates each item by marking a 100-mm line. Scores range from 0 to 100, with higher scores indicating a more positive perception.
Prosthetic Evaluation Questionnaire - Appearance scale (PEQ-AP)
时间窗: 30 days
A 5-item self-reported measure of the appearance domain. The participant rates each item by marking a 100-mm line. Scores range from 0 to 100, with higher scores indicating a more positive perception.
次要结局
- Patient Specific functional Scale (PSFS)(30 days)
- Psychosocial Impact of Assistive Device Scale (PIADS)(30 days)
- Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)(30 days)
- Visual Analog Scale (VAS) for the adequacy to life's project(30 days)
- EuroQuol - 5 Dimensions - 5 Levels (EQ-5D-5L)(30 days)
- Prosthetic Limb Users Survey of Mobility (PLUS-M)(30 days)
- Socket Comfort Scale (SCS)(30 days)
- Patient Specific functional Scale (PSFS)(30 days)
- Psychosocial Impact of Assistive Device Scale (PIADS)(30 days)
- Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)(30 days)
- Visual Analog Scale (VAS) for the adequacy to life's project(30 days)
- EuroQuol - 5 Dimensions - 5 Levels (EQ-5D-5L)(30 days)
- Prosthetic Limb Users Survey of Mobility (PLUS-M)(30 days)
- Socket Comfort Scale (SCS)(30 days)