Development of a conceptual model and measure of the impact of fear of falling in multiple sclerosis.

Fear of falling (FoF) is a common and distressing concern among persons with multiple sclerosis (MS) due to the gait and balance impairments associated with the disease. FoF – a persistent concern about falling that may cause individuals to avoid activities they are capable of performing safely – is often the focus of clinical care and research. Most efforts concentrate on assessing and reducing degree of FoF with a lack of attention to how FoF affects daily living activities and contributes to poorer function. The Falls Efficacy Scale International (FES-I), the most commonly used FoF measure for persons with MS, asks respondents to rate their FoF in the context of real or imagined activities (including those they do not perform) but does not assess FoF's impact on those activities. For example, a person may report high FoF on a FES-I item that asks about walking in places with crowds, but that high score does not reflect whether they actually do walk in crowded places or avoid that activity because of their FoF. In this scenario, the FoF score on the FES-I, though high, would still mask the functional limitations associated with FoF. Assessing the impact of FoF on daily living activities could serve as a more comprehensive indicator in clinical trials and research, offering a thorough understanding of the challenges faced by persons with MS regarding FoF and guide rehabilitation approaches. Unfortunately, existing measures of the impact of FoF, developed for the geriatric population, have conceptual limitations that may affect their clinical utility for use in persons with MS. The advancement of FoF research among persons with MS is currently stymied by two major factors, 1) the lack of a foundational conceptual model of FoF and 2) the lack of an outcome measure of the impact of FoF that takes into consideration input from persons with MS. The end goal of this study is to develop a validated and reliable Fear of Falling Impact Patient Reported Outcome (FOFI-PRO) measure. First, we will conduct focus groups with persons with MS to develop a patient-centered conceptual model of FoF in MS (Specific Aim 1). Then, we will develop FOFI-PRO item pools, containing a broad range of items that assess the impact of FoF (Specific Aim 2). Finally, we will deliver a finalized, validated, and reliable FOFI-PRO item bank and companion static short form for use in persons with MS (Specific Aim 3). Item pool development will involve a multi-stage process including extensive literature review, development of items based on focus group content, cognitive interviews with persons with MS, translatability and literacy evaluation, and expert input. The conceptual model and the FOFI-PRO measure produced in the proposed study will reveal specific activity groups and domains that are relevant for persons with MS but avoided due to FoF. These findings will guide the development and testing of a multidisciplinary intervention (a subsequent R01 application) to reduce the impact of FoF on daily living activities and promote independence. This study will help to personalize clinical practice, provide tools for new approaches in clinical trials, and ultimately improve the independence and quality of life of persons with MS. Project Number: 1R03HD117818-01A1 | Fiscal Year: 2026 | NIH Institute/Center: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Principal Investigator: Libak Abou | Institution: UNIVERSITY OF MICHIGAN AT ANN ARBOR, ANN ARBOR, MI | Award Amount: $312,000 | Activity Code: R03 | Study Section: Special Emphasis Panel[ZRG1 BP-G (92)] View on NIH RePORTER: https://reporter.nih.gov/project-details/11301611