ABSTRACT Introduction Falls are a major concern for older women and can result in significant injury. Footwear has been shown to improve or impair balance performance in older women, contingent upon footwear design features. Balance‐enhancing shoes may reduce the risk of falling but their acceptability is unknown. Acceptability is important because it influences the level of adherence to the intervention. The aim of this trial protocol is to describe the methodology of a randomised crossover trial to compare the acceptability of balance‐enhancing outdoor shoes versus minimalist outdoor shoes in older women and compare the effects of these two interventions on the perceived risk of falling and balance performance. Methods The trial will use a randomised two‐period crossover trial methodology. We will recruit 44 community‐dwelling women aged 65 years or older who will be randomised to receive a pair of minimalist shoes (Basic Lace Up Canvas Shoes, Kmart Australia Ltd, Mulgrave, Australia) or a pair of balance‐enhancing shoes (Balla Balance Leather Lace Up Boots, Ziera Australia, Abbotsford, Australia), which encompass key features known to be beneficial for balance such as adequate fixation, a firm heel counter, high heel collar, firm midsole and textured insole. The order of the interventions will be randomised. Cross‐over to the second shoe condition will occur at 6 weeks. Outcome measures will be collected at baseline, six and 12 weeks; the primary endpoint for assessing footwear acceptability for each shoe condition will be 6 weeks. The primary outcome measure will be footwear acceptability, evaluated using a modified version of the Monitor Orthopaedic Shoes Questionnaire. Secondary outcome measures include perceived risk of falling (the Falls Efficacy Scale International) and balance performance (upper body stability when walking, using the GyKo wearable sensor). Discussion This trial will evaluate the acceptability, perceived risk of falling and balance performance of minimalist shoes versus balance‐enhancing shoes. The findings will provide much‐needed evidence as to the acceptability of these two shoe types in older women. Such information may support footwear design to increase balance performance and reduce risk of falling. Trial Registration Australian and New Zealand Clinical Trial Registry (ACTRN12624001496505)
Azhar et al. (Wed,) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: