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Foot Strengthening to Improve Balance and Gait in Older Adults

NCT07384754 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-02-03

No results posted yet for this study

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

Interventions

DEVICE

Minimalist footwear

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

BEHAVIORAL

Foot strengthening exercises

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

DEVICE

ToePro foot strengthening device

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

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Allison H. Gruber, PhD · Indiana University, Bloomington

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07384754 on ClinicalTrials.gov