What this study is
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
What's being tested
- Minimalist footwear
Intervention · DEVICE
Habitual use of low-cushion, low-structure footwear designed to increase intrinsic foot muscle engagement during daily activities.
- Foot strengthening exercises
Intervention · BEHAVIORAL
Home-based exercises including toe flexion, toe press, and arch-control movements performed several times per week.
- ToePro foot strengthening device
Intervention · DEVICE
A dense foam exercise platform designed to strengthen intrinsic foot muscles through loaded toe press exercises in lengthened muscle positions.
Study details
- Official title
- Evaluation of a Novel Foot Strengthening Device for Improving Fall Risk, Balance, and Gait With Age
- Sponsor
- Indiana University
- Conditions
- Minimalist Footwear · Traditional Foot Exercise Program · Foot Strengthening Device (ToePro) · Control Condition
- Enrolling
- 160 people
- Starts
- 2025-10-21
- Est. completion
- 2027-06-30
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 45 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openSchool of Public Health-Bloomington
Bloomington, Indiana, United States
Recruiting
Study team
Sponsor
Indiana University
Study ID 26834, 23946
Principal investigator
Allison H. Gruber, PhD
Indiana University, Bloomington
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.