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: 10772958
• 负责人: Howard J. Hillstrom
• 金额: $ 5.5万
• 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 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10772958
• 关键词: Address; Algorithms; Ankle; Attention; Biomechanics; Capital; Clinic; Clinical; Collaborations; Data; Data Set; Deformity; Degenerative Disorder; Degenerative polyarthritis; Development; Devices; Diabetic Foot Ulcer; Doctor of Philosophy; Educational Curriculum; Elderly; Engineering; Equation; Evaluation; Exhibits; Flatfoot; Focus Groups; Funding; Gait; Hallux Limitus; Hallux Rigidus; Hallux Valgus; Hallux structure; Hand; Health; Height; Hip region structure; Holly; Incidence; Individual; Inferior; Innovation Corps; Joints; Knee; Knowledge; Laboratories; Length; Limb structure; Manuals; Manufacturer; Marketing; 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; Pain; Paper; Parents; Pathologic; Pathology; Patients; Peer Review; Phalanx; Phase; Physicians; Positioning Attribute; Procedures; Proxy; Publications; Publishing; Questionnaires; Recommendation; Research; Self Assessment; Small Business Innovation Research Grant; Source; Standardization; Stream; Structure; Subgroup; Surgeon; Surveys; Technology; Testing; Time; Translating; Visual; Weight; cohort; commercialization; cost; design; disability; falls; flexibility; foot; improved; indexing; innovation; instrument; instrumentation; invention; laptop; manufacture; meetings; mobility aid; physical therapist; portability; programs; prototype; response; smartphone application; tool; usability; user-friendly; walking speed; wireless

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.

项目概要 在 I-Corps 计划期间，目标将侧重于发现多样化的客户，以获得更清晰的了解 客户群和收入流、团队发明的转化以产生影响、定义 价值主张，将技术从研究实验室推进到商业世界，并满足 超过 100 个利益相关者将接受调查结果评估以及知识。 在 I-Corps 课程期间获得的成果将用于加强我们的母公司 SBIR 的商业化计划。 第一阶段的目标详述如下。 骨关节炎 (OA) 研究主要集中在髋部、膝部和手部，而对足部的关注较少。 跖趾 (MTP) 关节 OA（拇趾僵硬）是造成剧烈疼痛和活动受限的原因之一。 第一射线移动性过度或不足（FRM）是足部最常见的退行性疾病。 与许多疼痛、致残和威胁肢体的病变相关的第一射线移动性是优越的。 或骨结构在垂直载荷作用下沿 MTP 关节发生向下位移。 存在用于测试第一射线过度活动性（FRM ≥8mm）的实验室设备，但没有市售设备， 适用于诊所的可靠、用户友好的 FRM 设备。第一射线移动性和位置 (MAP1st) 版本 1 (V1)。 原型（PCT/US21/22791）有几个局限性。 SBIR 第一阶段项目的具体目标。 的目标是开发 MAP1st 版本 2 (V2)，以提高可靠性、实用性、效率和易用性 测量 FRM、位置和刚度。 焦点小组研究表明，MAP1st V2 正在制作原型，以解决 MAP1st V1 的局限性。 将从 20 个健康者那里获取一些有用的功能来满足客户需求。 患有无症状直肌和扁平足的个体，以及 20 名有病理的个体。 评估者的可靠性将根据重复的测量进行评估，同时还将检查亚组差异。 将通过区分健康组和病理组之间的 FRM 来评估设备效用 通用估计方程将评估临床医生对 V1 与 V2 的易用性。 SBIR 第一阶段项目将测试三个假设：(1) 将展示评估者内和评估者间的可靠性 使用 MAP1st V2 时 ICC (2,1)>0.75；(2) 第一射线移动性、位置和刚度将有所不同 患有无症状直肌、无症状扁平足、拇外翻和拇强直足的个体， 展示设备实用性；(3) MAP1st V1 和 V2 之间的可用性和效率将得到提高。 该研究团队已合作开展了 10 多个项目，并共同出版了 50 多篇出版物 此外，试点数据支持 MAP1st 检测扁平足与直肌过度活动的能力。 因此，预计该项目能够顺利完成。