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: 10609490
• 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/10609490
• 关键词: 3D Print; Address; Affect; Amputation; Back; Back Pain; Biomechanics; Boa; Compensation; Coupling; Custom; Degenerative polyarthritis; Diabetes Mellitus; Enrollment; Equilibrium; Evaluation; Female; Femur; Future; High Prevalence; Impairment; Individual; Injury; Joints; Kinetics; Knee; Knowledge; Leg; Limb structure; Low Back Pain; Lower Extremity; Manufacturer; Measures; Mechanics; Motion; Movement; Muscular Atrophy; Nylons; Obesity; Outcome; Pain; Participant; Patients; Persons; Physical activity; Printing; Prosthesis; Quality of life; Questionnaires; Reaction; Refit; Rehabilitation therapy; Research; Rest; Risk; Risk Reduction; Running; Scanning; Services; Skin; Suspensions; Technology; Tendon structure; Thick; Time; United States Department of Veterans Affairs; Veterans; Walking; carbon fiber; comorbidity; fall risk; functional improvement; functional loss; improved; kinematics; light weight; limb amputation; limb movement; male; manufacture; novel; prosthesis fitting; 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.

假肢接受腔也许是假肢中最重要的部分，因为它允许力和能量 在残肢和假肢组件之间转移，并影响成功 下肢截肢后的康复。下肢截肢的人通常都有一个刚性的 假肢接受腔然而，使用包含这种类型的接受腔的假体导致了负面影响。 继发性疾病，如骨关节炎、背痛、残肢皮肤破裂和不适; 57%的 假肢使用者对他们的假肢的舒适性不满意。单侧经胫骨或 经股截肢术通常以不对称的生物力学行走，例如地面反作用力、关节 运动和关节动力学。单侧截肢的人通常会补偿 受影响的腿的肌肉和肌腱与他们的未受影响的腿承担更大的力量。非对称力 可能导致截肢患者骨关节炎和腰痛的患病率更高。 接受腔的疼痛和不适当的配合会导致患者、修复师和患者的材料、时间和金钱的损失。 厂商一个可调节的插座，适应残肢体积的波动， 修复师优化每个患者的承窝匹配，这可以降低合并症的风险，如 骨关节炎，疼痛，以及需要长期重新安装假肢接受腔。此外，使用可调节的 接受腔设计有可能改善下肢截肢退伍军人的功能和舒适度。 Quorum Prosthetics（温莎，CO）开发了一种新的模块化可调节插座，Quatro插座， 这可以减少生物力学的不对称性，减少残肢相对于接受腔的运动， （套筒活塞），并因其适应能力而提高步行过程中的舒适度和满意度 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打印还减少了构建时间， 允许定制厚度变化，最小可达80 μm。每个插座都可以通过扫描 患者的肢体、石膏或现有的关节窝，因此它与个人用户形状匹配。Quatro插座采用3个Boa 拨盘（Boa Technology，汽船泉，CO），棘轮收紧或放松贯穿4 填充面板，以快速，系统地调整周围的插座的体积和压缩， 用户的肢体。这项技术允许用户在20秒内戴上或打开插座，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和可调节的Quatro假肢的效果 在生物力学、接受腔活塞运动和 10名女性和10名男性退伍军人接受单侧经胫骨截肢（目标1）， 10名女性和10名男性退伍军人在行走过程中单侧经股截肢（Aim 2）。 受试者将在测力跑步机上以0.75-1.5 m/s的速度在平地上行走， 使用每个插座的3°和6°上坡/下坡。在每一组插座试验后，受试者将 完成一份改良问卷（PEQ），评估他们的舒适度/满意度。之前和每年4 入组后10年，将要求受试者完成PEQ。一种可调节的假肢接受腔可以 改善人与假肢之间的机械耦合，并降低其生物力学性能 不对称，这可以增强功能并降低二次损伤的风险。渐缩套筒活塞 可以减少皮肤刺激和破损，这可能会降低假体的废弃率。具有更好贴合性 接受腔可以改善截肢退伍军人的舒适度、满意度、康复和功能， 最终可以改善他们的生活质量。我们的研究结果也可以用来告知未来的假肢接受腔 的设计.在这些方面，我们的研究将促进康复研究的知识，直接受益 退伍军人，并有助于退伍军人事务部提供的服务质量。