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

骨关节炎(OA)研究是NIAMS任务的主要组成部分，主要集中在髋关节、膝盖和 手，注意脚部的稀疏。第一跖趾(MTP)关节骨关节炎(Hallux Rigidus)，来源之一 剧烈疼痛和活动受限，是足部最常见的退行性疾病。过度或 第一射线活动能力不足(FRM)与许多疼痛、残疾和肢体威胁有关。 病理包括：跖骨性关节炎、外翻(HV)、内翻(HR)、踝关节痛、糖尿病 足部溃疡，足底凹陷，足底扁平。第一条射线(内侧楔骨、第一跖骨、近节指骨和 拇指)移动性是指这些骨骼结构在垂直方向上的移位 施加的载荷。虽然有几个实验室设备可以测试第一条射线的超移动性(frm≥8 mm)，但没有 市场上可获得的、可靠的、用户友好的临床FRM设备。研究目标是重新设计和 改进第一射线移动和定位(MAP1)版本1(V1)原型(PCT/US21/22791)，以提供 临床上可行的测量第一射线迁移率和位置的仪器。MAPirstV1有几个限制，包括 I)重量，ii)不接地的后脚，iii)视觉测量，iv)系绳膝上型电脑，以及v)手动数据输入。这个 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 用于测量FRM、位置和刚度。在MAP1 V2中，传感器将测量迁移率和 定位，而基于智能手机的应用程序将取代笔记本电脑和计算刚性。结果将被存储 保存在加密文件中并传输到电子病历中。使用这个设备，并以权力为导向 分析，数据集(n=80足)取自20例无症状直肌(NRF=20例)健康个体。 和扁平足(NPF=20)，拇外翻足10例(nhvf=20)，拇指僵硬足10例 (nhrf=20)。评分者内部和评价者之间的可靠性将通过重复测量进行评估，而分组 此外，还将考察不同之处。设备效用将通过区分健康的FRM和 和病理组使用广义估计方程(GEE)。可用性调查问卷将评估 临床医生(MD、DPM、DPT、技术员)V1与V2的易用性。将检验三个假设：(1)内部- 评分员和评分员之间的可靠性将表现出使用MAPfirst V2的ICC(2，1)&>0.75；(2)第一射线流动性，位置， 没有症状的直肌，无症状的扁平肌，拇外翻， 和拇指僵硬的脚展示了设备的实用性；(3)可用性和效率将在 MAP1V1和V2。这个研究团队已经合作了10多个项目，并共同发表了50多个项目 关于足部生物力学的出版物。此外，Pilot数据支持MAPfirst检测平面肌过度活动的能力 对直肌的脚。因此，预计该项目将顺利、成功地完成。MAPfirst V2将解决 通过为临床提供可靠的第一射线活动度和位置测量来满足未满足的临床需求 评估可用于制定最终使患者受益的治疗算法。

Osteoarthritis (OA) research, a primary component of the NIAMS mission, 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 including: tarsometatarsal OA, Hallux Valgus (HV), Hallux Rigidus (HR), metatarsalgia, diabetic foot ulceration, pes cavus, and pes planus. First ray (medial cuneiform, 1st metatarsal, proximal phalanx, and hallux) mobility is the superior or inferior displacement of these bony structures in response to a vertically applied 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 study goal is to redesign and improve the 1st Ray Mobility and Position (MAP1st) version 1 (V1) prototype (PCT/US21/22791) to provide a clinically viable instrument to measure 1st ray mobility and position. MAP1st V1 has several limitations, including i) weight, ii) ungrounded hindfoot, iii) visual measurement, iv) tethered laptop, and v) manual data entry. The Specific Aim is to develop MAP1st version 2 (V2) to increase the reliability, utility, efficiency, and ease of use for measuring FRM, position, and stiffness. In MAP1st V2, a transducer will measure mobility and position while a smartphone-based App will replace the laptop and compute stiffness. Outcomes will be stored in an encrypted file and transferred to electronic medical records. Using this device, and guided by power analysis, a data set (n=80 feet) will be acquired from 20 healthy individuals with asymptomatic rectus (nrf = 20) and planus (npf = 20) feet, 10 patients with hallux valgus feet (nhvf = 20) and 10 patients with hallux rigidus feet (nhrf = 20). 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 (GEE). A usability questionnaire will assess clinician (MD, DPM, DPT, technician) ease of use for V1 versus V2. Three hypotheses will be tested: (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; (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 smooth, successful completion of this project is anticipated. MAP1st V2 will address an unmet clinical need by providing reliable first ray mobility and position measurements for clinical assessment which could be used to formulate treatment algorithms that will ultimately benefit the patient.