Pilot Study to Assess Safety and Performances of a Energy Storing and Return (ESAR) Prosthetic Foot Made in Additive Manufacturing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of adverse events occurred during use of the Intervention prosthesis foot
研究概览
简要总结
A dynamic energy storage and return foot prosthesis is a type of prosthesis designed to mimic and restore the functionality and natural movement of the limb that has been amputated. This type of prosthesis is designed to allow patients to perform daily activities, even very dynamic ones, with greater ease and efficiency. The distinguishing feature of a dynamic energy storage and return prosthesis is the presence of a system that accumulates mechanical energy during the support phase on the ground and returns it during the push phase, increasing the amount of push itself. In foot prostheses, it is common to use carbon fiber blades or springs that deform during the support of the foot and then restore themselves, returning elastic energy during the subsequent push. This helps reduce the effort required to walk and allows for more fluid and natural movements. Additive Manufacturing (AM) technology is ideal for highly customized and high-value production. Orthoses/prostheses are particularly suited to exploit the potential of this technology. However, the lack of functional materials that meet different design needs, such as structure and comfort of the devices, has limited the use of AM mainly in orthoses. AM is promising for orthoses due to its customization capability and reduced production costs compared to traditional solutions. In particular, it has been shown how continuous filament carbon printing can lead to the creation of prostheses that have dynamic and energy return characteristics similar to or even superior to commercial ones. The present pilot clinical investigation aims to provide indications regarding the safety and performance of the 3D printed prosthesis - named PROFIL - in a real-world scenario. The state of the art has not yet defined the performance and safety of 3D printed prostheses with thermoplastic materials and continuous carbon fiber. Since greater comfort and the possibility of performing physical activity more easily with the use of these devices is expected, it is considered of interest for clinical practice to evaluate these prostheses. The primary objective of the study is therefore to evaluate the safety and performance of the device during walking on flat surfaces and more demanding tasks. The secondary objectives aims at evaluate usability and deformation of the 3D printed prosthesis under different loading conditions (slow and fast walking, ascending and descending ramps or steps) by mean of fiber-glass sensors integrated in the prosthesis foot.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Monolateral below knee amputation
- •Mobility level: K3 or K4
- •Age: 18-65 years old
- •Maximum weigth: 100 Kg
- •Collaborative subject
- •Clinically stable stump
排除标准
- •Not able to understand written and oral instructions
- •Problems to the stump
研究组 & 干预措施
PROFIL prosthesis foot
Recruited subjects with below kenen amputation wearing the experimental prosthesis foot (PROFIL)
干预措施: 3D printed prosthesis foot (Device)
Current prosthesis foot (PROFLEX XC)
Recruited subjects with below knee amputation wearing the currently used prosthesis foot (PROFIL)
干预措施: Current prosthesis foot (Device)
结局指标
主要结局
Number of adverse events occurred during use of the Intervention prosthesis foot
时间窗: Day 1 and Day 2
Adverse events may be: falling, stumbling, lower back pain as consequence of the prosthesis foot use, stump pain as consequence of the prosthesis foot use, breakage of the prosthesis foot
Change from Comparator of joints kinematics measured with Inertial Measurements Units (IMUs) placed on subject lower leg, upper arms and trunk
时间窗: Day 1 and Day 2
The IMUs record subject's joints kinematics while performing a series of motor tasks, i.e. walk of flat surfaces at a self-selected speed and ascend/descend stairs and ramps.
Change from Comparator of joints kinematics and dymamics measured with an optoelectronic system
时间窗: Day 1 and Day 2
The optoelectronic system records subject's joints kinematics and dynamics during subject's walk on a flat surface at a self-selected speed.
Change from Comparator of gait quality wihile ascending ramps with Hill Assessment Index (HAI)
时间窗: Day 1 and Day 2
HAI is a 11-points ordinal scale; the higher the score the better the gait quality while ascending ramps
Change from Comparator of gait quality while ascending stairs with Stair Ascending Index (SAI)
时间窗: Day 1 and Day 2
SAI is 13-points ordinal scale; the higher the score the better the gait quality while ascending ramps
Change from Comparator of equilibrium in orthostatism by mean of force plates
时间窗: Day 1 and Day 2
The subject is asked to stand still on a force plate for 30 seconds. The sway of the Centre of Pressure (COP) is recorded. The higher the sway, the lower the equilibrium in orthostatism
Change from Comparator of subject mobility with prosthesis by mean of the Amputee Mobility Predictor (AMP)
时间窗: Day 1 and Day 2
AMP is a 21-item objectve measure in which static and dynamic sitting and standing activities, as well as transfer and gait skills of progressing difficulty are performed. Score range is 0-47. Higher scores indicate better mobility.
Change form Comparator of functional mobility measured with the L-test
时间窗: Day 1 and Day 2
The subject starts from a sitting position. At the "Start" signal, the subject stands up from the chair, walks in a closed 10-meters L-shaped path, and sits down on the same chair. The time necessary to complete the path is measured. The lower the time, the higher the functional mobility.
Change from Comparator of load simmetry while standing up/sitting down from/on a chiar by mean of force plates
时间窗: Day 1 and Day 2
The subject is asked to sit on a chair with both the feets (sound foot and prosthesis foot) on different force plates. At the "Start" signal, the subject stands up, stands still for 5 seconds and sits down. The weigth distribution on the lower limbs is recorded during the entire task.
次要结局
- Change from Comparator of usability of the prosthesis foot(Day 1 and Day 2)
研究者
Emanuele Gruppioni
Engineer, Orthopaedic Techinician
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro