Foot-strengthening approaches to improve balance and walking in adults 45–85
Official title: Evaluation of a Novel Foot Strengthening Device for Improving Fall Risk, Balance, and Gait With Age
Run by Indiana University · NCT07384754 · Data updated 2026-11-12
This program will test whether wearing minimalist shoes, doing a home foot-exercise program, or using a ToePro device can strengthen feet and improve balance, walking, and fall outcomes in adults ages 45–85.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 45 Years and up |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Bloomington, Indiana) |
| Status | Recruiting |
| Started | October 21, 2025 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | August 19, 2026 |
| Trial ID | NCT07384754 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 45–85 who can walk without an assistive device, have no history of foot or ankle surgery, do not regularly use minimalist footwear, and have a BMI ≤ 40 are ideal candidates.
✕Probably not a fit
People with unresolved musculoskeletal, neurological, cardiovascular, pulmonary, metabolic, or renal conditions, current pregnancy, daily orthotic use, or any condition that limits safe participation in low-intensity exercise are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial assigns adults aged 45–85 to one of four groups: habitual minimalist footwear use, a prescribed foot-exercise program, use of a ToePro foot-strengthening device, or a no-intervention control. Participants complete laboratory testing of foot morphology, intrinsic and extrinsic foot muscle strength, standing balance, physical function, and walking gait at baseline and after an 8-week intervention. Active interventions are performed five days per week for eight weeks while all participants wear activity trackers to monitor daily steps and activity. A questionnaire-based follow-up on physical activity, footwear use, foot health, and falls is collected six months after the intervention period.
Why it matters
Potential benefit: If successful, these approaches could strengthen foot muscles, improve balance and walking stability, and lower fall risk for middle-aged and older adults.
How similar studies have gone: Smaller trials and pilot studies suggest foot-exercise programs and minimalist footwear can increase intrinsic foot strength and sometimes improve balance, but results are mixed and large randomized head-to-head comparisons are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * No foot or ankle issues for which study activities may be contraindicated * BMI \<= 40 Exclusion Criteria: * 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 * Any other disease or problems that may affect movement or the ability to exercise even at a low intensity
Where it's running
-
School of Public Health-Bloomington
Bloomington, Indiana, United States Recruiting
Study contacts
- Principal investigator: Allison H. Gruber, PhD — Indiana University, Bloomington
- Study coordinator: Marni Wasserman, MS
- Email: marnwass@iu.edu
- Phone: 812-856-2447
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.