A Low-Cost Upper-Extremity Prosthesis for Under-Served Populations

为服务不足的人群提供低成本上肢假肢

基本信息

批准号：
7619979
负责人：
BRADLEY D VEATCH
金额：
$ 34.03万
依托单位：
ADA TECHNOLOGIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-09-26 至 2010-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7619979
关键词：
Academy Accidents Address Adoption Affect Africa Agriculture American Amputation Amputees Animal Husbandry Appearance Area Award Belize Businesses Cambodia Central America Cessation of life Child Client Clinic Clinical Clinical Sciences Cognitive Computer software Computers Consult Cost Control Country Creativeness Development Devices Diagnosis Disabled Persons Disadvantaged Disease Documentation Durable Medical Equipment Economics Educational Materials Educational process of instructing Elderly Elements Emotional Engineering Ensure Equipment Eritrea Evaluation Facility Accesses Family Foot-drop Fostering Foundations Funding Gap Junctions Hand Heating Home environment Hour Human Humidity Individual Informed Consent Institutes Insurance Insurance Carriers Insurance Coverage International Investments Kenya Knowledge Laboratories Laws Left Leg Legal Legal patent Length Letters Licensing Life Life Style Light Limb structure Liquid substance Location Logistics Lower Extremity Manufactured Materials Manufacturer Name Marketing Mechanics Medical Methods Microprocessor Mining Mission Modeling Muscle Names National Institute of Child Health and Human Development Nicaragua Occupations Operative Surgical Procedures Orthopedics Orthotic Devices Patients Pattern Performance Persons Phase Physiological Physiology Play Polymers Population Preparation Prevalence Principal Investigator Procedures Process Prosthesis Prosthesis Design Qualifying Recommendation Recreation Red Cross Rehabilitation therapy Relief Work Reporting Research Research Design Research Ethics Committees Research Infrastructure Research Project Grants Residual state Resources Right-On Risk Role Rural Schools Science Self Perception Self-Help Devices Services Shipping Ships Shoulder Sierra Leone Small Business Innovation Research Grant Social Welfare Societies Solutions Source Sri Lanka Staging Stifle joint Stigmata Stress Stretching System Technology Test Result Testing Therapeutic Time Torque Training Translations Travel Underserved Population Uninsured United States United States National Institutes of Health Upper Extremity Validation Violence Visit Walking Work Wrist ankle joint dorsiflexor commercialization cost design disability engineering design experience extreme temperature flexibility follow-up foot functional restoration grasp gratitude human subject innovation instrument international center man manufacturing process member multiple disability new technology news orthotics outreach peer prevent product development programs prosthesis fitting psychologic psychological shock repaired research and development restoration rural area satisfaction self-renewal sensor skills social social stigma success symposium theories virtual ward web site working group

项目摘要

DESCRIPTION (provided by applicant): New upper-extremity assistive appliances coming into the orthotics and prosthetics (O&P) market are increasingly technologically sophisticated and expensive, which has given rise to a growing population of amputees who cannot obtain them or make use of them for various reasons and thereby enjoy no benefit. Current estimates put the number of upper-extremity amputees worldwide at nearly 25,000,000 persons, with approximately 80% of these living in rural areas and surviving through agriculture and animal husbandry. It is advantageous to help these amputees because experience has shown that with functional restoration comes renewed self-sufficiency and independence, and a majority of amputees fit with functional prostheses resume productive occupations, benefiting themselves, their families, and society at large. For this reason, some humanitarian agencies focus on providing assistive appliances, and while lower-extremity prosthetic options exist, they have been hampered in their efforts to assist upper-extremity amputees owing to a lack of affordable hardware. The Fundamental Objective of this three-phase SBIR program is to create a complete upper-extremity prosthesis that can be manufactured and distributed on a large scale to enable and delight disadvantaged amputees for whom few or no other viable rehabilitative options exist. In Phase I of this SBIR project, ADA successfully demonstrated the technical and economic feasibility of a new low-cost upper- extremity prosthesis intentionally designed for distribution in the United States and abroad to overcome treatment disparities affecting under-served populations. As recommended by expert prosthetists active in humanitarian relief efforts, ADA's prosthetic system conveys specific benefits to amputees: 1) it is comfortable and restores useful grasping function; 2) it alleviates emotional and psychological shock caused by amputation and fosters a positive self-image; and 3) it restores a more normal appearance that bolsters social acceptance, particularly in cultures having strong stigmas against disfigurement and disability. Phase II incorporates two stages of field validations involving human subjects. These evaluations will be IRB- approved and will enable ADA's well-qualified research team to fully validate the system's performance, amputees' functional proficiency using it, and its acceptability in a cultural context. A kit comprising the prosthesis and additional materials will be developed to facilitate global distribution while helping amputees become proficient and able to use the systems to maximum advantage in their lives. Finally, manufacturing infrastructure will be set up to supply Phase III market demand; distribution channels already exist and have expressed their eagerness to begin supplying ADA's system to their clients.

描述（由申请人提供）：进入矫形器和假肢（O＆P）市场的新上超级辅助设备在技术上越来越复杂且昂贵，这导致了越来越多的amputees人群，这些amputees无法获得或出于各种原因而使用它们，因此没有受益。目前的估计数量使全球范围内的高级截肢数量达到了近25,000,000人，其中约有80％的人居住在农村地区，并通过农业和畜牧业生存。帮助这些截肢者是有利的，因为经验表明，随着功能恢复的发展，自给自足和独立性会带来重新获得的自给自足和独立性，并且大多数截肢者都符合功能性假体恢复生产性职业，从而使自己，家庭和整个社会受益。因此，一些人道主义机构专注于提供辅助设备，尽管存在低级假体选择，但由于缺乏负担得起的硬件，他们努力协助高级截肢者的努力受到了阻碍。这个三相SBIR计划的基本目标是创建一个完整的高级假体，可以大规模制造和分发，以使和使弱势群体感到厌恶，而很少有或根本没有其他可行的康复选择。在该SBIR项目的第一阶段，ADA成功地证明了有意在美国和国外分发的新的低成本上肢假体的技术和经济可行性，以克服影响服务不足人群的治疗差异。正如专业的假肢专家所建议的那样，ADA的假肢系统传达了对截肢者的特定好处：1）舒适并恢复有用的掌握功能； 2）它减轻截肢引起的情感和心理冲击，并促进积极的自我形象； 3）它恢复了更正常的外观，以增强社会认可，尤其是在具有强烈的污名化和残疾的文化中。第二阶段结合了涉及人类受试者的两个现场验证阶段。这些评估将获得IRB批准，并将使ADA合格的研究团队能够充分验证系统的性能，使用IT的Amputees的功能能力及其在文化背景下的可接受性。由假体和其他材料组成的套件将开发出来，以促进全球分布，同时帮助截肢者熟练并能够利用系统来最大程度地利用其生活。最后，将建立制造基础设施以提供III期市场需求；分销渠道已经存在，并表示渴望开始向客户提供ADA的系统。