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，目标将侧重于发现不同的客户，以获得更清晰的了解 客户群和收入流，将团队的发明转化为影响力， 价值主张，将技术从研究实验室推向商业世界， 未满足的临床需求。将对100多个利益攸关方进行调查。结果评估，连同知识 在I-Corps课程中获得的知识将用于加强我们的商业化计划。母公司SBIR 第一阶段的目标详述如下。 骨关节炎（OA）的研究主要集中在髋关节、膝关节和手部，对足部的关注较少。第一 跖趾（MTP）关节OA（拇趾僵硬），一种严重疼痛和活动受限的来源，是 最常见的足部退行性疾病。过度或不足的第一射线流动性（FRM）已被 与许多疼痛、致残和威胁肢体的病理相关。第一射线流动性是上级的 或骨结构响应于垂直载荷而沿MTP关节沿着向下移位。虽然有几个 存在用于测试第一射线超动性（FRM ≥ 8 mm）的实验室装置，没有市售的， 为临床提供可靠、用户友好的FRM设备。第一射线移动性和位置（MAP 1st）版本1（V1） 原型（PCT/US 21/22791）具有若干限制。母公司SBIR第一阶段项目的具体目标 是开发MAP第1版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。 MAP 1st V2正在进行原型设计，以解决MAP 1st V1的局限性。一项焦点小组研究显示， 一些有用的功能来满足客户的需求。将从20名健康人中获取数据集（n=80英尺） 无症状的直肌和扁平足患者，以及20例病理患者。评级者内部和评级者之间 将从重复测量中评估评定者可靠性，同时还将检查亚组差异。 将通过使用以下方法区分健康组和病理组之间的FRM来评估器械效用 广义估计方程可用性调查问卷将评估V1与V2的临床医生易用性。 SBIR第一阶段项目将检验三个假设：（1）评分者内和评分者间的信度将表现出 ICC（2，1）>0.75，适用于MAP 1st V2;（2）第一射线移动性、位置和刚度将在不同的 具有无症状直肌、无症状扁平、拇趾外翻和拇趾僵硬足的个体， 证明器械实用性;以及（3）MAP 1st V1和V2之间的可用性和效率将得到改善。 这个研究团队已经合作了10多个项目，共同出版了50多篇出版物 生物力学此外，飞行员数据支持MAP 1st检测平足与直足过度活动的能力。 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.