Evaluation of a Novel Foot Strengthening Device for Improving Fall Risk, Balance, and Gait in Adults Aged 45-85

What this Trial Is About

Researchers are evaluating whether different foot-strengthening methods can improve foot strength, balance, walking ability, and outcomes related to falls in middle-aged and older adults aged 45 to 85 years. The study compares minimalist footwear, a foot exercise program, a foot-strengthening device called ToePro, and no intervention to see which approach may provide greater benefits. Participants are randomly assigned to one of four groups: wearing minimalist footwear during daily activities for eight weeks, completing foot and ankle exercises targeting foot muscles for eight weeks, using the ToePro device for prescribed exercises over eight weeks, or receiving no intervention and continuing usual activities. All participants undergo two lab sessions at the start and end of the eight-week period to assess foot strength, balance, physical function, and walking gait. During the study, physical activity is monitored using wearable devices and participants complete daily logs to track adherence to their assigned intervention. Additional questionnaires about physical activity, balance confidence, foot health, and falls are collected at baseline, after the intervention, and six months later. The main outcomes measured include changes in foot muscle strength, gait characteristics, balance tests, and walking performance.

Foot Strengthening to Improve Balance and Gait in Older Adults