Assessing the Acceptability and Effectiveness of a Novel Therapeutic Footwear in Reducing Foot Pain and Improving Function among Older Adults: A Crossover Randomized Controlled Trial

Abstract

Introduction: Nearly, a quarter of older adults suffer from frequent foot pain, impacting their quality of life. While proper footwear can alleviate this, design issues often hinder regular use. This study evaluated novel therapeutic footwear, designed for aesthetics and custom fit, to reduce foot pain. We hypothesized that older adults would experience less foot pain and favor the new footwear over their own.

Methods: This 12-week crossover randomized controlled trial evaluated the effectiveness of OrthoFeet therapeutic footwear on reducing foot pain in older adults (n = 50, age = 65 ± 5, 18% male) with moderate to severe pain. Participants were assigned to either the AB or BA sequence. In AB, they wore OrthoFeet shoes for 6 weeks and then their own shoes for another 6 weeks; BA followed the reverse order. Pain and function were measured using the Foot Function Index. Acceptability was assessed through a technology acceptance model (TAM) questionnaire. Data collected at baseline, six, and 12 weeks were analyzed using t tests, χ2 tests, and generalized linear model.

Results: Compared to participants' own shoes, OrthoFeet shoes significantly reduced foot pain and disability. Notable improvements were observed in "foot pain at its worst," "foot pain at the end of the day," "overall pain score," and "overall Foot Function Index score," all showing statistically significant reductions (p < 0.050). Participants reported high adherence to wearing the OrthoFeet shoes, averaging 8 h per day and 5.8 days per week. TAM scores favored OrthoFeet shoes over participants' own shoes in terms of ease of use, perceived benefit, and intention to recommend. Significant differences were noted in components representing perceived joint pain relief (p < 0.001, χ2 = 21.228) and the intention of use as determined by the likelihood of recommending the shoes to a friend with a similar condition (p < 0.001, χ2 = 29.465). Additionally, a majority of participants valued the appearance of the shoes, with 66% prioritizing shoe appearance and 96% finding the study shoes more stylish than their previous ones.

Conclusion: This study underscores the significance of design and custom fit in promoting continuous wear for effective foot pain reduction in older adults. More research is needed on the intervention's long-term impacts.

Keywords: Foot; Foot orthoses; Pain perception; Patient preference; Shoes.