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

开发标准化、可靠且易于使用的临床仪器来测量前足内侧的第一射线活动度和位置，以协助临床决策和治疗

• 批准号: 10483379
• 负责人: Howard J. Hillstrom
• 金额: $ 25.96万
• 依托单位: BIOMED CONSULTING, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-16 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10483379
• 关键词: Address; Algorithms; Ankle; Attention; Biomechanics; Capital; Cellular Phone; Clinic; Clinical; Clinical assessments; Computerized Medical Record; Consult; Data; Data Set; Deformity; Degenerative Disorder; Degenerative polyarthritis; Development; Devices; Diabetic Foot; Diabetic Foot Ulcer; Doctor of Philosophy; Engineering; Equation; Exhibits; Flatfoot; Focus Groups; Funding; Gait; Goals; Hallux Limitus; Hallux Rigidus; Hallux Valgus; Hallux structure; Hand; Health; Height; Hip region structure; Holly; Incidence; Individual; Inferior; Investigation; Joints; Knee; Laboratories; Length; Limb structure; Manuals; Manufacturer Name; Marketing; Measurement; Measures; Mechanics; Medial; Metatarsal bone structure; Metatarsalgia; Metatarsophalangeal joint structure; Mission; Motion; National Institute of Arthritis and Musculoskeletal and Skin Diseases; Operative Surgical Procedures; Orthopedics; Osteotomy; Outcome; Pain; Paper; Pathologic; Pathology; Patients; Peer Review; Phalanx; Phase; Physicians; Plant Roots; Podiatry; Positioning Attribute; Procedures; Proxy; Publications; Publishing; Questionnaires; Research; Rotation; Self Assessment; Small Business Innovation Research Grant; Source; Standardization; Structure; Subgroup; Surgeon; Talipes cavus; Technology; Testing; Time; Transducers; Visual; Weight; base; cohort; cost; design; disability; encryption; falls; flexibility; foot; improved; indexing; innovation; instrument; instrumentation; laptop; physical therapist; portability; power analysis; prototype; response; smartphone Application; tool; usability; user-friendly; walking speed; wireless

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.

NIAMS任务的主要组成部分骨关节炎（OA）研究专注于臀部，膝盖和 手，稀疏的脚关注。第一个MetataTapophangeal（MTP）关节OA（Hallux rigidus），一个来源 实质性的疼痛和有限的活动性是脚最常见的退化性疾病。过多或 第一射线移动性不足（FRM）与众多痛苦，残疾和肢体威胁有关 病理包括：TARSOMETATATATATATASAL OA，HALLUX外血（HV），Hallux origidus（HR），Metatarsalgia，糖尿病 脚溃疡，PES Cavus和PES Planus。第一射线（内侧楔形，第1个meta骨，近端phalanx和 术语的移动性是这些骨质结构的上位移或下移 施加的负载。虽然存在一些实验室设备来测试第一射线过敏性（FRM≥8mm），但没有 诊所的市售，可靠，用户友好的FRM设备。研究目标是重新设计和 改善第一射线移动性和位置（MAP1ST）版本1（V1）原型（PCT/US21/22791）提供一个 临床上可行的仪器，以测量第一射线迁移率和位置。 MAP1ST V1有几个限制，包括 i）重量，ii）未接地的后脚，iii）视觉测量，iv）束缚的笔记本电脑和V）手动数据输入。这 具体目的是开发MAP1ST 2（V2），以提高可靠性，实用性，效率和易度性 用于测量FRM，位置和刚度的使用。在MAP1ST V2中，传感器将测量移动性和 位置的同时，基于智能手机的应用将替换笔记本电脑并计算刚度。结果将存储 在加密文件中并转移到电子病历中。使用此设备，并由电源引导 分析，将从20个不对称直肌（NRF = 20）的健康个体中获取数据集（n = 80英尺） 和Planus（NPF = 20）脚，10例Hallux feet（NHVF = 20）的患者和10例Hallux Ergidus脚的患者 （NHRF = 20）。评估者和评估者间的可靠性将从复制的措施中评估，而亚组 还将检查差异。设备实用程序将通过区分健康来评估 使用通用估计方程（GEE）的病理组。可用性问卷将评估 临床医生（MD，DPM，DPT，技术人员）对V1与V2的易用性。将测试三个假设：（1） 评估者和评估者间的可靠性将存在ICC（2,1）> 0.75用于使用MAP1ST V2； （2）第一个射线移动性，位置， 与不对称直肌，不对称平面，呼号外翻的个体之间的僵硬将有所不同 和Hallux Ergidus脚展示了设备实用程序； （3）可用性和效率将提高 MAP1ST V1和V2。这个调查团队已合作进行了10多个项目，并共同发布了50多个 脚步生物力学的出版物。此外，飞行员数据支持MAP1ST检测Planus中过度运动的能力 与直肌脚。因此，预计该项目的平稳完成完成。 MAP1ST V2将寻址 通过为临床提供可靠的第一射线移动性和位置测量，一种未满足的临床需求 可用于制定最终受益于患者的治疗算法的评估。