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

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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.