Orthofeet: A Prospective Proof of Concept Trial to Evaluate an Innovative Pain Relief Footwear

A clinical study at Baylor College of Medicine is being conducted to evaluate the short- and intermediate-term benefits and effectiveness of a novel pain relief footwear, Orthofeet. This 12-week randomized crossover trial aims to recruit 50 eligible ambulatory adults (aged 50 years or older) with moderate self-reported foot pain. Participants will be randomly assigned to Group AB (25 subjects) or Group BA (25 subjects), with no differences in assessments or eligibility criteria between the groups. In Group AB, participants will wear Orthofeet shoes for 6 weeks, followed by their own shoes for another 6 weeks, while Group BA will follow the reverse order. Pain and function, the primary outcomes, will be measured using the Foot Function Index (FFI), and acceptability will be assessed using a Technology Acceptance Model (TAM) questionnaire. Data will be collected at baseline, 6 weeks, and 12 weeks.