Development of a Standardized, Reliable and Easy-to-Use Clinical Instrument to Measure First Ray Mobility and Position of the Medial Forefoot to Assist with Clinical Decisions and Treatments

项目摘要 在i-Corps计划期间，目标将集中在多样化的客户发现上，以获得更清晰的了解 客户细分和收入流，转变团队的发明以产生影响，定义 价值主张，将技术从研究实验室推进到商业世界，并满足 未得到满足的临床需求。将对100多名利益相关者进行调查。结果评估，连同知识 在i-Corps课程期间获得的，将用于加强我们的商业化计划。父SBIR 第一阶段目标详述如下。 骨关节炎(OA)的研究主要集中在髋关节、膝盖和手部，而对足部的研究较少。第一 掌指(MTP)关节骨关节炎(Hallux Rigidus)是疼痛和活动受限的来源 足部最常见的退行性疾病。第一射线移动性(FRM)过高或不足 与许多疼痛、致残和威胁肢体的病理有关。第一光线机动性是最好的 或垂直载荷作用下沿MTP关节的骨性结构下移。虽然有几个人 存在用于测试第一射线超迁移率(Frm≥8 mm)的实验室设备，尚无商用设备， 适用于临床的可靠、用户友好的FRM设备。第一光线移动和定位(MAP1)版本1(V1) 原型(PCT/US21/22791)有几个限制。母公司SBIR第一阶段项目的具体目标 是开发MAP1版本2(V2)，以提高可靠性、实用性、效率和易用性 测量FRM、位置和刚度。 MAP1V2正在进行原型设计，以解决MAP1V1的局限性。一项焦点小组研究显示， 一些有用的功能，以满足客户需求。一个数据集(n=80英尺)将从20名健康人那里获得 无症状的直肌和扁平足患者，20例有病理改变的患者。评分员内和评分员间 评分员的可靠性将通过重复测量进行评估，同时还将检查分组差异。 设备的效用将通过区分健康组和病理组之间的FRM来评估 广义估计方程。可用性问卷将评估临床医生对V1和V2的易用性。 SBIR第一阶段项目将检验三个假设：(1)评价员内部和评价员之间的可靠性将表现出 使用MAP1V2的ICC(2，1)&gt；0.75；(2)第一射线的迁移率、位置和硬度在以下方面有所不同 有无症状的直肌、无症状的扁平肌、拇外翻和拇指僵硬的人， 展示了设备的实用性；以及(3)MAP1V1和V2之间的可用性和效率将得到提高。 这个研究团队已经合作了10多个项目，并共同出版了50多本关于徒步的出版物 生物力学。此外，Pilot数据支持MAP1功能，以检测平直肌与直肌之间的过度活动。 因此，预计该项目将圆满完成。

Project Summary During the I-Corps program, the aim will focus on diverse customer discovery to gain a clearer understanding of the customer segments and revenue streams, transformation of the team’s invention to impact, defining the value proposition, advancing the technology from the research lab to the commercial world, and meeting unmet clinical needs. Over 100 stakeholders will be surveyed. The result evaluation, together with knowledge gained during the I-Corps curriculum, will be used to strengthen our commercialization plan. The parent SBIR Phase I aim is detailed below. Osteoarthritis (OA) research has focused on the hip, knee, and hand, with sparse attention to the foot. First metatarsophalangeal (MTP) joint OA (Hallux Rigidus), a source of substantial pain and limited mobility, is the most common degenerative disease in the foot. Excessive or insufficient 1st ray mobility (FRM) has been associated with numerous painful, disabling, and limb threatening pathologies. First ray mobility is the superior or inferior displacement of bony structures along the MTP joint in response to vertical load. While a couple of laboratory devices exist to test 1st ray hypermobility (FRM ≥8mm), there are no commercially available, reliable, user friendly, FRM devices for the clinic. The 1st Ray Mobility and Position (MAP1st) version 1 (V1) prototype (PCT/US21/22791) has several limitations. The Specific Aim of the parent SBIR Phase I project is to develop MAP1st version 2 (V2) to increase the reliability, utility, efficiency, and ease of use for measuring FRM, position, and stiffness. MAP1st V2, is being prototyped to address the limitations of MAP1st V1. A focus group study has revealed some useful features to address customer needs. A data set (n=80 feet) will be acquired from 20 healthy individuals with asymptomatic rectus and planus feet, and 20 individuals with pathology. Intra-rater and inter- rater reliability will be assessed from replicated measures, while subgroup differences will also be examined. Device utility will be assessed by distinguishing FRM between the healthy and pathologic groups using Generalized Estimation Equations. A usability questionnaire will assess clinician ease of use for V1 versus V2. Three hypotheses will be tested for the SBIR Phase I project: (1) Intra-rater and inter-rater reliability will exhibit an ICC (2,1)>0.75 for use of MAP1st V2; (2) First ray mobility, position, and stiffness will be different across individuals with asymptomatic rectus, asymptomatic planus, hallux valgus, and hallux rigidus feet, demonstrating device utility; and (3) Usability and efficiency will be improved between MAP1st V1 and V2. This investigational team has collaborated on 10+ projects and co-published 50+ publications on foot biomechanics. Further, pilot data supports MAP1st ability to detect hypermobility in planus vs. rectus feet. Hence, a successful completion of this project is anticipated.