160 Participants Needed

Foot Strengthening for Balance and Gait Issues

MW
AH
Overseen ByAllison H. Gruber, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Indiana University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

AH

Allison H. Gruber, PhD

Principal Investigator

Indiana University, Bloomington

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 45-85 who can walk without help and have not had foot or ankle surgery. They should not be regular users of minimalist footwear, have a BMI of 40 or less, and no foot issues that would make the study's activities unsafe for them.

Inclusion Criteria

I can walk without help from devices or prosthetics.
No history of regular minimalist footwear use
I don't have any foot or ankle problems that would stop me from joining the study.
See 3 more

Exclusion Criteria

I use orthotics in my everyday shoes.
Pregnancy
I have a condition that could affect my ability to do even low-intensity exercise.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline laboratory testing of foot strength, balance, physical function, and walking gait

1 week
1 visit (in-person)

Intervention

Participants perform foot strengthening exercises or wear minimalist footwear five days/week for eight weeks

8 weeks
Daily logs for compliance

Post-Intervention Assessment

Participants complete post-intervention laboratory testing of foot strength, balance, physical function, and walking gait

1 week
1 visit (in-person)

Follow-up

A follow-up questionnaire assessing physical activity, footwear use, foot health, and falls is administered

6 months
1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Foot strengthening exercises
  • Minimalist footwear
  • ToePro

Trial Overview

The trial tests if different ways to strengthen feet—using a ToePro device, wearing minimalist shoes, doing exercises, or no treatment at all—can improve balance, walking ability, and reduce falls over an eight-week period.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: Minimalist footwearExperimental Treatment1 Intervention
Group II: Foot exercise programExperimental Treatment1 Intervention
Group III: ControlActive Control1 Intervention
Group IV: Foot strengthening device (ToePro)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+