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使命的主要组成部分，主要集中在髋关节、膝关节和 手，稀疏的注意到脚。第一跖趾（MTP）关节OA（拇趾僵硬）， 严重疼痛和活动受限是足部最常见的退行性疾病。过度或 第一射线活动度（FRM）不足与许多疼痛、残疾和肢体威胁有关 病理学包括：跗跖OA、拇外翻（HV）、拇强直（HR）、跖骨痛、糖尿病 足溃疡、高弓足和扁平足。第一排（内侧楔骨、第一跖骨、近节趾骨和 拇趾）移动性是这些骨结构响应于垂直方向的移动而上级或向下移位。 外加载荷虽然有几个实验室设备可以测试第一射线超动性（FRM ≥ 8 mm），但没有 市售的、可靠的、用户友好的、用于临床的FRM设备。该研究的目标是重新设计和 改进第一射线移动性和位置（MAP 1st）版本1（V1）原型（PCT/US 21/22791），以提供 临床上可行的仪器，用于测量第一射线移动性和位置。MAP 1st V1有几个限制，包括 i）重量，ii）不接地的后足，iii）视觉测量，iv）系留的膝上型计算机，以及v）手动数据输入。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 用于测量FRM、位置和刚度。在MAP 1st V2中，传感器将测量移动性， 而基于智能手机的应用程序将取代笔记本电脑和计算刚度。结果将被存储 并将其传输到电子病历中。使用这个装置，在能量的引导下 分析时，将从20名无症状直肌（nrf = 20）的健康个体中采集数据集（n=80英尺） 10例拇外翻足（NHVF = 20），10例拇僵硬足 (nhrf= 20）。将根据重复测量评估评估者内和评估者间可靠性，而亚组 也将审查差异。将通过区分FRM与健康 和病理组使用广义估计方程（GEE）。可用性调查问卷将评估 V1与V2的临床医生（MD、DPT、技师）易用性。三个假设将被测试：（1）内- 对于使用MAP 1st V2，评定者和评定者间可靠性将表现出ICC（2，1）>0.75;（2）第一射线移动性，位置， 并且刚度在患有无症状直肌、无症状扁平肌、拇趾外翻 和拇趾僵硬足，证明器械实用性;（3）可用性和效率将在 MAP 1st V1和V2。这个研究团队已经合作了10多个项目，共同出版了50多本 足部生物力学的出版物。此外，飞行员数据支持MAP 1st检测扁平部过度活动的能力 vs.直肌足因此，预计该项目将顺利、圆满完成。MAP 1st V2将解决 通过为临床提供可靠的第一射线移动性和位置测量， 评估，其可用于制定最终将使患者受益的治疗算法。