Introduction Assessing an individual’s physical capacity to move independently and safely to perform activities of daily living (i.e., functional mobility) can be approached through various modalities, including performance-based physiological tests, observational assessments, and self-report questionnaires. The purpose of this study was to establish a patient-reported outcome measure (PROM), termed PROWalkTM, based on the PROMIS Item Bank 2.0 – Physical Function, to assess perceived mobility challenges, specifically related to gait and balance function, and evaluate its performance in comparison to the Patient-Specific Functional Scale (PSFS) within a population of individuals with sensory peripheral neuropathy.

Methods The PROWalk PROM was developed with expert clinician input as a custom short form composed of selected items from the Item Bank. Participants with lower extremity peripheral neuropathy who had been prescribed a wearable sensory prosthesis were administered the PROWalk and the PSFS, a perceived functional mobility assessment via telecommunications at baseline and six weeks after wearing the sensory prosthesis.

Results Both measures displayed significant increases (i.e., improvements) over time with large effect sizes and upward linear trends for each instrument between baseline and six weeks. When normalized, the measures showed no bias, large limits of agreement, and no normalized change between the instruments.

Discussion The PROWalk PROM detected significant improvements in perceived functional mobility over time and showed strong temporal stability and suitability for standardized group-level comparisons, which were similar to the PSFS. Overall, the PROWalk appears to be a valid PROM for capturing improvements in self-reported functional mobility related to gait and balance function.

Lars Oddsson is cofounder of RxFunction and coinventor of the Walkasins sensory prosthesis device. He is CTO of the company, serves on the Board of Directors, and is a shareholder in the company. Sutton B. Richmond is a full-time employee of RxFunction, while Laura Jacobs and Yvonne Rumsey are part-time employees of RxFunction. Caleb Kumar and Carole A. Tucker have no conflict of interest to declare.

This study was funded by RxFunction, Inc.

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Ethics committee/IRB of Advarra IRB gave ethical approval for this work

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