The goal of this clinical trial is to learn whether different foot-strengthening strategies can improve foot strength, balance, walking ability, and fall-related outcomes in middle-aged and older adults (ages 45-85 years).
The main questions it aims to answer are:
* Does foot strength change from baseline after an 8-week foot-strengthening intervention? * Do balance, gait, and physical function improve following different foot-strengthening approaches?
Researchers will compare minimalist footwear use, a foot exercise program, a foot-strengthening device (ToePro), and no intervention to see if these interventions lead to greater improvements in foot strength, balance, gait, and fall-related outcomes than no intervention.
Participants will:
* Complete baseline and post-intervention laboratory testing of foot strength, balance, physical function, and walking gait * Perform foot strengthening exercises or wear minimalist footwear (if applicable) five days/week for eight weeks * Complete daily logs to record intervention compliance
Healthy adults: 45 years of age or older
Able to walk without an assistive walking device or lower limb prosthesis for at least 6 minutes
No history of foot or ankle surgery
No history of regular minimalist footwear use
Deemed unfit for physical activity by the Physical Activity Readiness Questionnaire (PAR-Q)
Current or history of an unresolved musculoskeletal, neurological, cardiovascular, pulmonary/respiratory, metabolic, renal condition, disease, or problem
Use of orthotics in daily (i.e., non-athletic) footwear
Pregnancy
Parallel
Minimalist footwear
DeviceHabitual use of low-cushion, low-structure footwear designed to increase intrinsic foot muscle engagement during daily activities.
Foot strengthening exercises
BehavioralHome-based exercises including toe flexion, toe press, and arch-control movements performed several times per week.
ToePro foot strengthening device
DeviceA dense foam exercise platform designed to strengthen intrinsic foot muscles through loaded toe press exercises in lengthened muscle positions.
Change From Baseline in Hallux Flexion Strength (Curl)
Change in maximal hallux (big toe) flexion strength assessed using a standardized hallux curl test (i.e., flexion at the metatarsal interphalangeal joints) with a dynamometer. Participants perform brief maximal voluntary contractions, and peak force output is recorded. Higher values indicate greater hallux curl strength.
Change From Baseline in Lesser Toes Flexion Strength (Curl)
Change in maximal lesser toes flexion strength assessed using a standardized lesser toes curl test (i.e., flexion at the metatarsal interphalangeal joints) with a dynamometer. Participants perform brief maximal voluntary contractions, and peak force output is recorded. Higher values indicate greater lesser toes curl strength.
Change From Baseline in Hallux Flexion Strength (Press)
Change in maximal hallux flexion strength assessed using a toe press test that isolates hallux flexion at the metatarsophalangeal joint. Strength is measured using a force-instrumented platform, with higher values indicating greater hallux press strength.
Change From Baseline in Lesser Toe Flexion Strength (Press)
Change in maximal lesser toes flexion strength assessed using a toe press test that isolates flexion at the metatarsophalangeal joints. Strength is measured using a force-instrumented platform, with higher values indicating greater lesser toes press strength.
Change From Baseline in IMU-Derived Gait Acceleration Magnitude
Change in gait acceleration magnitude measured using an inertial measurement unit (IMU) during walking assessments. Acceleration magnitude is derived from tri-axial accelerometer signals and reflects overall movement intensity during gait.
Footwear Minimalism (Minimalist Index)
Footwear minimalism assessed using the Minimalist Index (MI) rating scale applied to participants' commonly worn footwear. Higher scores indicate greater footwear minimalism.
Intervention Compliance Survey Responses
Participant-reported adherence to the assigned intervention assessed using standardized, electronic compliance surveys. Survey items quantify frequency and duration of prescribed footwear use, exercise sessions, or device use during the intervention period. Higher values indicate greater adherence to the assigned intervention protocol.
FitBit-Derived Moderate-to-Vigorous Physical Activity (MVPA)
Moderate-to-vigorous physical activity (MVPA) assessed using a wearable activity tracker (FitBit) during the intervention period. MVPA is quantified as minutes per day spent in moderate-to-vigorous intensity activity, summarized across the intervention period. Higher values indicate greater engagement in MVPA.
Click on the lead sponsor to view all of their trials.
