Improving Socket Fit in Female and Male Veterans with Transtibial and TransfemoralAmputation

改善经小腿和经股截肢术的女性和男性退伍军人的接受腔贴合度

• 批准号: 10424648
• 负责人: Alena Grabowski
• 金额: --
• 依托单位: VA EASTERN COLORADO HEALTH CARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10424648
• 关键词: 3D Print; Address; Affect; Amputation; Back; Back Pain; Biomechanics; Boa; Coupling; Custom; Degenerative polyarthritis; Diabetes Mellitus; Enrollment; Equilibrium; Evaluation; Female; Future; High Prevalence; Impairment; Individual; Injury; Joints; Kinetics; Knee; Knowledge; Leg; Limb Prosthesis; Limb structure; Low Back Pain; Lower Extremity; Manufacturer Name; Measures; Mechanics; Motion; Movement; Muscular Atrophy; Nylons; Obesity; Outcome; Pain; Participant; Patients; Persons; Physical activity; Prosthesis; Quality of life; Questionnaires; Reaction; Rehabilitation therapy; Research; Rest; Risk; Running; Scanning; Services; Skin; Suspensions; Technology; Tendon structure; Thick; Time; United States Department of Veterans Affairs; Veterans; Walking; carbon fiber; comorbidity; fall risk; functional loss; improved; improved functioning; kinematics; light weight; limb amputation; limb movement; male; novel; osteoarthritis pain; prosthesis wearer; prosthetic socket; rehabilitation research; residual limb; satisfaction; skin irritation; socket design; treadmill

A prosthetic socket is perhaps the most important part of a prosthesis because it allows force and energy to be transferred between the residual limb and prosthetic components, and influences successful rehabilitation following lower-limb amputation. People with lower-limb amputation are typically fit with a rigid prosthetic socket. However, the use of a prosthesis incorporating this type socket has led to negative secondary conditions such as osteoarthritis, back pain, residual limb skin breakdown and discomfort; 57% of prosthetic users are dissatisfied with the comfort of their prosthesis. People with unilateral transtibial or transfemoral amputation typically walk with asymmetric biomechanics, such as ground reaction forces, joint motion, and joint kinetics. People with unilateral amputation typically compensate for the functional loss of the muscles and tendons of the affected leg with greater forces borne by their unaffected leg. Asymmetric forces likely contribute to the higher prevalence of osteoarthritis and low back pain in people with a leg amputation. Pain and improper fit of the socket can result in loss of material, time, and money for patients, prosthetists, and manufacturers. An adjustable socket that accommodates residual limb volume fluctuations could allow prosthetists to optimize socket fit for each patient, which could reduce the risk of comorbidities such as osteoarthritis, pain, and the need to re-fit prosthetic sockets in the long term. Moreover, use of an adjustable socket design has the potential to improve function and comfort of Veterans with lower limb amputation. Quorum Prosthetics (Windsor, CO) has developed a new modular adjustable socket, the Quatro socket, that could decrease biomechanical asymmetry, decrease movement of the residual limb relative to the socket (socket pistoning), and improve comfort and satisfaction during walking due to its ability to accommodate residual limb volume changes of up to 12%. The Quatro socket is produced by 3D printing high-strength Nylon 12, which is stronger and lighter than typically used carbon fiber; 3D printing also decreases build time and allows customized changes down to 80 μm in thickness. Each socket can be custom printed from a scan of a patient's limb, cast, or existing socket, so it is form-fit to the individual user. The Quatro socket utilizes 3 Boa dials (Boa Technology, Steamboat Springs, CO) that ratchet to tighten or loosen cables that run through 4 padded panels to quickly and systematically adjust the volume and compression of the socket around the user's limb. This technology allows a user to don or doff the socket in ~20 sec and adjust for volume changes up to 12%. We will determine the effects of using a conventional rigid and an adjustable Quatro prosthetic socket with the same suspension and prosthetic components on the biomechanics, socket pistoning, and comfort/satisfaction of 10 female and 10 male Veterans with a unilateral transtibial amputation (Aim 1) and of 10 female and 10 male Veterans with a unilateral transfemoral amputation (Aim 2) during walking. Subjects will walk on a force-measuring treadmill at 0.75-1.5 m/s on level ground and at 1.0 m/s on uphill/downhill slopes of 3° and 6° using each socket. After each set of trials with a socket, subjects will complete a modified questionnaire (PEQ) that assesses their comfort/satisfaction. Prior to and each year for 4 years after enrollment, subjects will be asked to complete a PEQ. An adjustable prosthetic socket could improve the mechanical coupling between the person and prosthesis and reduce their biomechanical asymmetry, which could enhance function and lower the risk of secondary injury. Decreasing socket pistoning could reduce skin irritation and breakdown, which may lower abandonment of prostheses. A better fitting socket could improve comfort, satisfaction, rehabilitation, and function for Veterans with amputations, which could ultimately improve their quality of life. Our results can also be used to inform future prosthetic socket designs. In these ways, our research will advance knowledge in rehabilitation research, directly benefit Veterans, and contribute to the quality of services provided by the Department of Veterans Affairs.

假肢插座可能是假肢最重要的部分，因为它提供力量和能量。 在残肢和假体之间的转移，并影响成功 下肢截肢后的康复。下肢截肢的人通常适合使用僵硬的 假肢插座。然而，包含这种类型插座的假体的使用已经导致了负面的 继发性疾病，如骨关节炎、背痛、残肢皮肤受损和不适；57%的 假肢使用者对假肢的舒适性不满意。患有单侧经胫骨或 经股截肢手术通常采用不对称的生物力学，如地面反作用力、关节 运动和关节动力学。单侧截肢的人通常会补偿失去的功能 受影响腿的肌肉和肌腱，其未受影响的腿承受更大的力。不对称力 可能导致截肢的人患骨性关节炎和腰背痛的几率更高。 疼痛和插座的不适当安装可能会导致患者、修复师和 制造商。可调节肢体体积波动的可调节插座可以 假肢医生优化适合每个患者的插座，这可以降低并发症的风险，如 骨关节炎、疼痛，以及长期重新安装假体插座的需要。此外，使用可调节的 插座设计有可能改善下肢截肢退伍军人的功能和舒适度。 Quorum Prosthetics(Windsor，CO)开发了一种新的模块化可调插座，Quatro插座， 这可以减少生物力学的不对称性，减少残肢相对于窝的运动 (插座活塞)，并提高了步行的舒适性和满意度，因为它能够容纳 残肢体积变化高达12%。Quatro插座由3D打印高强度尼龙制成 12，比通常使用的碳纤维更坚固、更轻；3D打印还可以缩短构建时间和 允许定制厚度最小为80μm的更改。每个插座都可以通过扫描 患者的四肢、石膏或现有插座，因此它适合个人用户的形状。Quatro插座使用3个Boa 拨盘(Boa Technology，Steamboft Springs，CO)，用于棘轮拧紧或松开贯穿4个月的电缆 衬垫面板可快速、系统地调整插座周围的音量和压缩 使用者的肢体。这项技术允许用户在约20秒内戴上或脱下插座，并根据音量变化进行调整 高达12%。我们将确定使用传统的刚性假体和可调节的四边形假体的效果。 插座具有相同的悬架和假体上的生物力学部件，插座活塞，以及 10名女性和10名男性退伍军人单侧胫骨截肢的舒适度/满意度(目标1)和 10名女性和10名男性退伍军人在步行过程中进行单侧股骨截肢(目标2)。 受试者将在测力跑步机上以0.75m/1.5m/S的平地和1.0m/S的速度行走 每个插座使用3°和6°的上坡/下坡坡度。在每一组带有插座的试验之后，受试者将 完成一份修改后的问卷(PEQ)，评估他们的舒适度/满意度。在此之前及每年4 注册数年后，受试者将被要求完成PEQ。一种可调节的假肢插座可以 改善人与假体的机械耦合，降低其生物力学性能 不对称，可以增强功能，降低二次损伤的风险。减径套筒活塞 可减少对皮肤的刺激和破坏，从而减少假体的丢弃。更好的贴合 插座可以改善退伍军人截肢后的舒适度、满意度、康复和功能，这是 最终可以提高他们的生活质量。我们的结果也可以用来为未来的假体插座提供信息 设计。通过这些方式，我们的研究将推进康复研究的知识，直接受益 为退伍军人提供服务，并为退伍军人事务部提供的服务质量作出贡献。