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.

骨关节炎 (OA) 研究是 NIAMS 任务的主要组成部分，重点关注髋关节、膝关节和 手部，稀疏关注足部第一跖趾 (MTP) 关节 OA (Hallux Rigidus)，这是骨关节炎的来源。 剧烈疼痛和活动受限是足部最常见的退行性疾病。 第一射线移动性 (FRM) 不足与许多疼痛、残疾和肢体威胁有关 病理包括：跗跖骨 OA、拇趾外翻 (HV)、拇趾僵硬 (HR)、跖骨痛、糖尿病 足部溃疡、高弓足和扁平足。 拇趾）移动性是指这些骨结构响应于垂直方向的上移或下移。 虽然有一些实验室设备可以测试第一射线过度活动性（FRM ≥8mm），但没有。 该研究的目标是重新设计和用于临床的商用、可靠、用户友好的 FRM 设备。 改进第一射线移动性和位置（MAP1st）版本1（V1）原型（PCT/US21/22791）以提供 临床上可行的测量第一射线移动性和位置的仪器有几个局限性，包括 i) 重量，ii) 不接地的后足，iii) 目视测量，iv) 系留笔记本电脑，以及 v) 手动数据输入。 具体目标是开发 MAP1st 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 MAP1st V2 中，传感器将测量移动性和刚度。 位置，同时基于智能手机的应用程序将取代笔记本电脑并存储计算结果。 使用此设备将其保存在加密文件中并传输到电子病历中，并由电源引导。 分析中，将从 20 名无症状直肌 (nrf = 20) 的健康个体获取数据集 (n=80 英尺) 扁平足 (npf = 20) 足、10 名拇外翻足 (nhvf = 20) 患者和 10 名拇强直足患者 (nhrf = 20) 评估者内部和评估者间的可靠性将通过重复测量进行评估，而分组 还将通过区分健康者之间的 FRM 来评估设备效用。 和病理组使用广义估计方程（GEE）进行可用性调查问卷的评估。 临床医生（MD、DPM、DPT、技术人员）V1 与 V2 的易用性将进行测试：(1) 内部。 使用 MAP1st V2 时，评估者和评估者间的可靠性将表现出 ICC (2,1)>0.75 (2) 第一射线迁移率、位置、 无症状直肌、无症状扁平肌、拇外翻的个体的硬度会有所不同， 和拇强直脚展示设备实用性；（3）可用性和效率将得到提高； MAP1st V1 和 V2。该研究团队已合作完成 10 多个项目并共同发表了 50 多个项目。 此外，试点数据支持 MAP1st 检测扁平肌过度活动的能力。 因此，预计 MAP1st V2 将顺利、成功地完成。 通过为临床提供可靠的第一射线移动性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。