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?

This trial examines whether different methods to strengthen feet can improve foot strength, balance, and walking ability in people aged 45 to 85. It will compare minimalist footwear, a foot exercise program, and a foot-strengthening device called ToePro against no intervention. Participants must be able to walk unaided and should not have had foot or ankle surgery. Those who have not regularly used minimalist footwear and have no serious foot issues might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative methods for enhancing foot health and mobility.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these foot-strengthening strategies are safe for improving balance and gait?

A previous study found that wearing minimalist shoes for an extended period helped older adults improve their balance and reduced their risk of falling. Most participants felt more stable in these shoes. The ToePro device strengthens foot and leg muscles, aiding balance and walking. Although specific safety data is unavailable, it is generally used for exercise.

Research has shown that foot exercises can increase foot muscle size by up to 22.3% and improve balance. Participants reported feeling more aware of their feet and legs. These exercises also enhanced balance and reduced the fear of falling.

Overall, these treatments—minimalist shoes, the ToePro device, and foot exercises—are generally well-tolerated, with no serious side effects reported. They focus on strengthening feet and improving balance, offering practical and safe ways to support better walking and stability in daily life.12345

Why are researchers excited about this trial?

Researchers are excited about the potential of foot strengthening exercises, minimalist footwear, and the ToePro device to improve balance and gait issues. Unlike standard treatments, which often involve orthotics or physical therapy focusing on the entire lower body, these methods specifically target the foot and ankle muscles, potentially leading to more direct improvements. Minimalist footwear encourages natural foot movement, while the ToePro device offers a focused exercise protocol, making these options unique by promoting intrinsic foot muscle engagement. This approach may lead to enhanced stability and mobility, offering hope for more effective and tailored interventions for those struggling with balance and gait problems.

What evidence suggests that this trial's treatments could be effective for improving foot strength, balance, and gait?

Research has shown that minimalist shoes, which participants in this trial may wear, can help older adults improve balance and reduce the risk of falling. People wearing these shoes often feel steadier and walk in a way that increases muscle activity in their thighs. Another treatment arm in this trial involves the ToePro foot-strengthening device, which increased foot strength by an average of 55% in just eight weeks. This device targets the muscles in the foot and leg. Additionally, some participants will engage in foot strengthening exercises, which also lead to better balance and walking ability. These exercises strengthen the foot muscles, helping to prevent falls and improve walking.12678

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+

Citations

The effects of intrinsic foot muscle strengthening interventions ...

Anticipated results​​ We hypothesize that both IFM strengthening exercises and prescribed minimal footwear use will result in reduced fall risk ...

Effects of a 12-week intrinsic foot muscle strengthening ...

Strengthening the plantar intrinsic foot muscles (PIFM) may improve gait and balance in older adults and, therefore, may have potential for fall prevention.

The impact of intrinsic foot muscle strengthening exercises in ...

Previous researches have demonstrated IFM strengthening exercise is effective in improving functional outcomes, including balance, strength ...

Effects of a 12-week gait retraining program combined with ...

After the 12-week gait retraining combined with foot core exercise, the strength of hallux flexion and the MPJ flexors improved effectively. It ...

Foot–ankle therapeutic exercise program can improve gait ...

The 12-week foot–ankle therapeutic exercises improved significantly fast-gait speed (primary outcome) (p = 0.020), ankle range of motion (p = ...

Effects of a foot strengthening program on foot muscle ...

8-weeks of foot exercises increased the intrinsic foot muscles volumes up to 22.3%. · Strengthening the intrinsic foot muscles positively affected running ...

The Effects of Physical Exercise on Balance and Prevention of ...

The meta-analysis showed improvements in dynamic balance (p = 0.008), static balance (p = 0.01), participants' fear of falling (p = 0.10), balance confidence (p ...

The effect of a gait and balance training program on an...

The aim of this study was to investigate the effect of a gait and balance training program on an unstable mudflats surface in older adults.