Foot-strengthening approaches to improve balance and walking in adults 45–85
Evaluation of a Novel Foot Strengthening Device for Improving Fall Risk, Balance, and Gait With Age
NA · Indiana University · NCT07384754
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 45 Years to 85 Years |
| Sex | All |
| Sponsor | Indiana University (other) |
| Locations | 1 site (Bloomington, Indiana) |
| Trial ID | NCT07384754 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy adults: age 45-85 years old * Able to walk without an assistive walking device or lower limb prosthesis * 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 this trial is running
Bloomington, Indiana
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Minimalist Footwear, Traditional Foot Exercise Program, Foot Strengthening Device, Control Condition, Balance, Gait, Intrinsic Foot Muscles, Minimalist footwear