Recruiting

Minimalist Footwear, ToePro, Foot Exercises

Sponsor:

Indiana University

Code:

NCT07384754

Conditions

Minimalist Footwear

Traditional Foot Exercise Program

Foot Strengthening Device (ToePro)

Control Condition

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Accepted

Interventions

Minimalist footwear

Foot strengthening exercises

ToePro foot strengthening device

Study Details

Brief summary:

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

Conditions

Minimalist Footwear

Traditional Foot Exercise Program

Foot Strengthening Device (ToePro)

Control Condition

Study ID

NCT07384754

Start date

Oct 21, 2025

Status verified date

Aug, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Minimalist footwear

Habitual use of low-cushion, low-structure footwear designed to increase intrinsic foot muscle engagement during daily activities.

Foot strengthening exercises

Home-based exercises including toe flexion, toe press, and arch-control movements performed several times per week.

ToePro foot strengthening device

A dense foam exercise platform designed to strengthen intrinsic foot muscles through loaded toe press exercises in lengthened muscle positions.

Primary outcome measure

  • Change From Baseline in Hallux Flexion Strength (Curl) [ Time Frame: From enrollment to the end of the intervention at 8 weeks ]
  • Change From Baseline in Lesser Toes Flexion Strength (Curl) [ Time Frame: From enrollment to the end of the intervention at 8 weeks ]
  • Change From Baseline in Hallux Flexion Strength (Press) [ Time Frame: From enrollment to the end of the intervention at 8 weeks ]
  • Change From Baseline in Lesser Toe Flexion Strength (Press) [ Time Frame: From enrollment to the end of the intervention at 8 weeks ]
  • Change From Baseline in Gait Kinetic Variables [ Time Frame: From enrollment to the end of the intervention at 8 weeks ]
  • Change From Baseline in Joint Angles during Gait [ Time Frame: From enrollment to the end of the intervention at 8 weeks ]
  • Change From Baseline in Joint Range of Motion During Gait [ Time Frame: From enrollment to the end of the intervention at 8 weeks ]
  • Change From Baseline in Stance Time During Gait [ Time Frame: From enrollment to the end of the intervention at 8 weeks ]
  • Change From Baseline in Step Length During Gait [ Time Frame: From enrollment to the end of the intervention at 8 weeks ]
  • Change From Baseline in Cadence During Gait [ Time Frame: From enrollment to the end of the intervention at 8 weeks ]
  • Change From Baseline in Step Width During Gait [ Time Frame: From enrollment to the end of the intervention at 8 weeks ]
  • Change From Baseline in 6-Minute Walk Test Distance [ Time Frame: From enrollment to the end of the intervention at 8 weeks ]
  • Change From Baseline in 30-Second Sit-to-Stand Test Performance [ Time Frame: From enrollment to the end of the intervention at 8 weeks ]
  • Change From Baseline in 4-Stage Balance Test Performance [ Time Frame: From enrollment to the end of the intervention at 8 weeks ]
  • Change From Baseline in Single-Leg Heel-Raise Test Performance [ Time Frame: From enrollment to the end of the intervention at 8 weeks ]

Central Contacts and Locations

Central contacts

Marni Wasserman, MS

812-856-2447marnwass@iu.edu

Allison H. Gruber, PhD

812-856-2447ahgruber@iu.edu

Locations

School of Public Health-Bloomington

Recruiting

Bloomington, Indiana, United States, 47405

More Information

Sponsor

Indiana University

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Balance
  • Gait
  • Intrinsic Foot Muscles
  • Minimalist footwear
  • Aging
  • Fall prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Indiana University on 2026-08-19.