AFARI: A Stylized Adaptive Mobility and Fitness Device for Outdoor Movement

 描述（由申请人提供）：骨关节炎（OA）是下肢肌肉骨骼残疾的主要原因，在超过15%的美国人口中被诊断出。虽然没有治愈方法，但无论年龄、合并症、疼痛、严重程度或残疾如何，运动仍然是管理OA的核心治疗方法。然而，许多患有这种疾病的人并没有定期健身 因此，由于疼痛和活动性降低，他们可能求助于侵入性和危险的关节置换手术，或者由于久坐不动的生活方式，他们可能经历健康下降。本I期STTR提案的目标是完成AFARI（tm）的设计、安全性和可用性测试，供诊断为下肢OA的个体使用。AFARI是一种三轮器械，旨在满足那些没有足够的移动支持就不太可能、完全不能或不愿意参加步行锻炼的人群的未满足需求，并提供了减轻体重的机制。AFARI的创建是为了促进参与户外步行，慢跑或跑步。虽然耐用的医疗设备（DME），如助行器，拐杖和手杖，可提供给那些谁需要它，DME是最低限度的功能，户外运动，并经常被认为是耻辱和不便。因此，许多患有下肢OA的人放弃了这些设备。AFARI旨在减轻下肢OA患者的放弃，并消除其定期户外健身活动的一些障碍。AFARI将允许用户安全和成功地启动、维持和/或增加其锻炼计划的长度和强度。在AFARI的初步市场调查中，受访者表示，如果他们采用AFARI，则形式与功能和易用性同样重要，并且器械的设计考虑了这些原则。通过STTR的努力，将研究AFARI及时商业化的几个主要障碍，以便消除这些障碍。AFARI的安全性和稳定性将通过机械测试和人体评估来证明。将同时根据体重承重测量值对承重监测系统进行确认。将对通过跌倒恐惧测试的跌倒风险降低进行评价;关于可用性、去污名化设计和总体 将收集AFARI的可取性，并计划任务，以教育临床医生， AFARI及其好处。为了实现本I期研究的目标，证明AFARI用于下肢OA患者的初步可行性，以便我们可以在II期继续扩大工作，将满足四个具体目标：AIM 1）AFARI的功能和安全性验证; AIM 2）承重监测系统的同步验证;目的3）进行初步可用性测试，重点关注舒适度、功能、便利性、减少耻辱感和设计偏好，目的4）规划关于AFARI的临床医生教育。

 DESCRIPTION (provided by applicant): Osteoarthritis (OA), diagnosed in over 15% of the US population, is the primary cause of musculoskeletal lower extremity disability. Although there is no cure, exercise remains the core treatment to manage OA regardless of age, comorbidity, pain, severity or disability. Yet, many people with this condition do not engage in regular fitness and thus may resort to invasive and risky joint replacement surgeries due to pain and decreased mobility, or they may experience health decline due to sedentary lifestyles. The goal of this Phase I STTR proposal is to complete the design, safety and usability testing of AFARI(tm), for use by individuals diagnosed with lower extremity OA. Created to fill an unmet need for populations who without adequate mobility support would be less likely, fully unable, or unwilling to participate in ambulatory exercise, AFARI is a three-wheeled device, and provides the mechanisms to unload body weight. AFARI was created to promote participation in outdoor walking, jogging, or running. Although durable medical equipment (DME) such as walkers, crutches and canes is available to those who need it, DME is minimally functional for outdoor exercise, and is often perceived as stigmatizing and inconvenient. Therefore, many people with lower-extremity OA abandon these devices. AFARI was designed to mitigate abandonment and eliminate a number of barriers to regular outdoor fitness activity by persons with lower-extremity OA. AFARI will allow the user to safely and successfully initiate, maintain, and/or increase the length and intensity of their exercise programs. In preliminary market research for AFARI, respondents indicated that form was as important as function and ease of use if they were to adopt AFARI and the device was designed with these principles in mind. Through this STTR effort, several major barriers to timely commercialization of AFARI will be researched so that they can be eliminated. The safety and stability of AFARI will be proven though mechanical testing and human evaluation. The weight bearing monitoring system will be concurrently validated against bodily weight bearing measures. An evaluation of the reduction in fall risk tested by fear of falling will be undertaken; Data on usability, destigmatizing design, and overall desirability of AFARI will be collected, and, tasks will be planned to educate clinicians regarding AFARI and its benefits. To accomplish the objective of this Phase I study, to demonstrate the initial feasibility of AFARI for people with lower extremity OA, such that we can proceed with expanded efforts in Phase II, four specific aims will be met: AIM 1) Validation of the functionalit and safety of AFARI; AIM 2) Concurrent validation of the weight bearing monitoring system; AIM 3) Conducting preliminary usability testing focusing on comfort, function, convenience, stigma reduction, and design preferences, and AIM 4) Planning for clinician education about AFARI.