Foot Strengthening to Improve Balance and Gait in Older Adults

Part of paid clinical trials in Bloomington, Indiana.

Sponsor
Indiana University
Study ID
NCT07384754
Status
Recruiting
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Conditions

  • Control Condition
  • Foot Strengthening Device (ToePro)
  • Minimalist Footwear
  • Traditional Foot Exercise Program

Eligibility Criteria

Sex
ALL
Age
45 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Minimalist footwear — DEVICE
    Habitual use of low-cushion, low-structure footwear designed to increase intrinsic foot muscle engagement during daily activities.
  • Foot strengthening exercises — BEHAVIORAL
    Home-based exercises including toe flexion, toe press, and arch-control movements performed several times per week.
  • ToePro foot strengthening device — DEVICE
    A dense foam exercise platform designed to strengthen intrinsic foot muscles through loaded toe press exercises in lengthened muscle positions.

Study Details

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

Key Dates

Start date
Jan 1, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Minimalist footwear
    Participants are instructed to wear minimalist footwear during activities of daily living for 8 weeks, progressively increasing wear time according to a standardized schedule.
  • No Intervention: Control
    Participants do not receive any foot-strengthening intervention and continue usual activities.
  • Active Comparator: Foot strengthening device (ToePro)
    Participants use a commercially available foot-strengthening device (ToePro) for a prescribed exercise protocol over 8 weeks.
  • Experimental: Foot exercise program
    Participants complete a prescribed foot and ankle strengthening exercise program targeting intrinsic and extrinsic foot muscles over an 8-week period.

Primary Outcome Measure

Change From Baseline in Hallux Flexion Strength (Curl) [ Time Frame: From enrollment to the end of the intervention at 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
School of Public Health-BloomingtonBloomingtonIndiana47405-

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By research site
School of Public Health-Bloomington· Bloomington, IN

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