Foot Muscle Strengthening for Fall Prevention in Older Adults

Overseen By Regina Kaufman, EdD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Springfield College

Disqualifiers: Poor foot sensation, amputations, cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how strengthening foot muscles can help prevent falls in older adults. It compares two approaches: specific foot exercises (intrinsic foot muscle strengthening exercises) and wearing minimal footwear, against a control group receiving basic fall prevention advice. The goal is to determine if these methods can improve balance and reduce falls. Ideal participants are those who can walk short distances, feel unsteady on their feet, worry about falling, or have fallen in the past year. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance fall prevention strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that exercises to strengthen the small muscles in the feet are safe for older adults. Studies have found no reports of serious side effects, and participants experienced no major problems during these exercises.

Regarding minimal footwear, studies indicate that these shoes can improve balance and walking. Older adults wearing minimal footwear felt more stable and had better awareness of their feet, without reporting any major negative effects.

Both treatments are well-tolerated and have shown positive results in improving balance, with no serious safety concerns noted in previous research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for fall prevention in older adults, such as balance training or medication, intrinsic foot muscle strengthening exercises focus directly on enhancing the strength of the foot muscles themselves. This approach is unique because it aims to improve stability and reduce fall risk by targeting the muscles that play a crucial role in maintaining balance. Researchers are excited about this method because it could provide a more natural and sustainable way to prevent falls, potentially leading to greater independence and safety for older adults.

What evidence suggests that this trial's treatments could be effective for fall prevention in older adults?

Research has shown that strengthening the inner foot muscles can help older adults move better and may lower their risk of falling. In this trial, one group will perform intrinsic foot muscle strengthening exercises, which studies have found important for preventing falls by developing stronger toe muscles. Another group will wear special lightweight shoes while walking, which earlier research showed improves balance and movement. Older adults who wore these shoes reported feeling more stable and having better foot sensation. This trial tests both approaches to help older adults maintain their balance. ^{2 3 6 7 8}

Who Is on the Research Team?

Erin Futrell, PhD

Principal Investigator

Springfield College

Are You a Good Fit for This Trial?

This trial is for older adults who can walk at least household distances and have concerns about falling, either because they feel unsteady, worry about falls, or have fallen in the past year. It's also for those with a Timed Up and Go score over 12 seconds indicating fall risk.

Inclusion Criteria

I can walk around my house, with or without help like a cane.

I feel unsteady, worry about falling, or have fallen in the past year.

Exclusion Criteria

I have not had any lower back or leg injuries or surgeries in the last 6 months.

Poor foot sensation (Semmes-Weinstein)

I have had an amputation on my lower limb.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform intrinsic foot muscle strengthening exercises or minimal footwear prescribed walking for 16 weeks

16 weeks

1 initial in-person instruction session, 1 follow-up meeting, bimonthly phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment, with ongoing falls diaries and bimonthly phone calls

12 months

Long-term monitoring

Participants continue their intervention twice per week and are monitored for long-term fall rate

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Control
• Intrinsic foot muscle strengthening exercises
• Minimal footwear with prescribed walking

Trial Overview

The study tests two foot-strengthening methods to prevent falls: exercises targeting muscles inside the foot and walking prescribed distances in minimal footwear. Participants are compared with a control group not receiving these interventions.

How Is the Trial Designed?

Group I: Intrinsic foot muscle exercise Experimental Treatment 1 Intervention

This group will perform intrinsic foot muscle strengthening exercises

Group II: Minimal Footwear Active Control 1 Intervention

This group will perform prescribed walking in and daily wear of minimally cushioned footwear

Group III: Control Placebo Group 1 Intervention

This group will be given a falls prevention brochure and seated upper extremity and lower extremity active range of motion activities.

Who Is Running the Clinical Trial?

Springfield College

Lead Sponsor

Trials

10

Recruited

2,900+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Published Research Related to This Trial

Intrinsic foot muscle (IFM) strengthening exercises do not significantly change the mobility of the medial longitudinal arch (MLA) in the short term (4 weeks), but they show medium-term benefits (8 weeks) in improving MLA mobility, although the evidence quality is low.

IFM exercises enhance dynamic balance in healthy individuals both in the short term (4 weeks) and medium term (8 weeks), with common exercises including the short-foot and toe-towel curl, indicating their potential effectiveness for improving foot function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of intrinsic foot muscle strengthening on the medial longitudinal arch mobility and function: A systematic review. de Souza, TMM., de Oliveira Coutinho, VG., Tessutti, VD., et al.[2023]

Intrinsic foot muscle strengthening (IFMS) interventions in older adults (≥65 years) showed improvements in strength, balance, and functional mobility, potentially reducing fall risk, based on a systematic review of 9 studies involving 1674 participants.

The evidence quality was fair, and while IFMS had little effect on gait, subjective reports suggested that enhanced proprioception and sensory input may contribute to improved mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of intrinsic foot muscle strengthening on functional mobility in older adults: A systematic review. Futrell, EE., Roberts, D., Toole, E.[2022]

The review analyzed studies on intrinsic foot muscles in individuals with Hallux Valgus (HV) deformity, revealing that these muscles have different functional capacities and morphological characteristics compared to those without HV.

Specifically, there is evidence of muscle performance impairment in the abductor hallucis and flexor hallucis brevis muscles in subjects with HV, indicating a potential area for targeted rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The functional capacity and morphological characteristics of the intrinsic foot muscles in subjects with Hallux Valgus deformity: A systematic review. Moulodi, N., Azadinia, F., Ebrahimi-Takamjani, I., et al.[2021]

This study will assess the impact of a 12-week intrinsic-foot-muscle exercise program on postural stability in 120 older adults at risk of falls, comparing it to other exercise methods and a control group.

The trial aims to provide evidence on how strengthening intrinsic foot muscles can improve stability and potentially reduce falls, while also monitoring for any adverse events during the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of intrinsic-foot-muscle exercise combined with the lower extremity resistance training on postural stability in older adults with fall risk: study protocol for a randomised controlled trial. Lai, Z., Pang, H., Hu, X., et al.[2021]

Strengthening exercises for the plantar intrinsic foot muscles (PIFMs) may improve foot function during walking, with low-certainty evidence showing a beneficial effect on vertical ground reaction forces.

There is very low-certainty evidence that PIFM strength training can enhance dynamic balance control, highlighting the need for more rigorous studies, especially in older adults who are at higher risk of falls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of interventions anticipated to improve plantar intrinsic foot muscle strength on fall-related dynamic function in adults: a systematic review. Willemse, L., Wouters, EJM., Bronts, HM., et al.[2022]

A 12-week program of gradually increasing physical activity in 27 adults with obesity led to significant improvements in foot structure, including thinner feet and higher, stiffer arches.

While ankle muscle strength also increased with physical activity, changes in foot arch height and stiffness were not linked to improvements in ankle muscle strength, suggesting that physical activity benefits foot structure independently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of increasing physical activity on foot structure and ankle muscle strength in adults with obesity. Zhao, X., Tsujimoto, T., Kim, B., et al.[2020]

A study involving 16 healthy adults found that different 3D foot-ankle exercises, specifically short foot (SF) and toe spread out (TSO), significantly activated intrinsic foot muscles, particularly the abductor hallucis (AbH) and flexor hallucis brevis (FHB).

The 3D flexion exercise was more effective than other exercises in activating the extensor hallucis longus (EHL), suggesting that specific exercises can be tailored for targeted strengthening of intrinsic foot muscles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Intrinsic Foot Muscle Activities between Therapeutic and Three-Dimensional Foot-Ankle Exercises in Healthy Adults: An Explanatory Study. Park, DJ., Hwang, YI.[2021]

Strength training of the intrinsic foot muscles (IFMs) significantly improves foot function, as evidenced by reductions in navicular drop and Foot Posture Index scores, along with enhancements in balance and strength, based on a meta-analysis of 13 studies.

While IFM exercises showed positive effects on foot posture and balance, they did not significantly reduce pain, indicating that while they are beneficial for certain outcomes, they may not address all foot-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence of Intrinsic Foot Muscle Training in Improving Foot Function: A Systematic Review and Meta-analysis. Jaffri, AH., Koldenhoven, R., Saliba, S., et al.[2022]

Walking in minimalist footwear significantly increases foot muscle size and strength, showing similar effectiveness to dedicated foot strengthening exercises over an 8-week period with 57 runners participating.

Both interventions (minimalist shoe walking and foot strengthening exercises) led to measurable improvements in muscle size and strength, while the control group showed no changes, highlighting the importance of stimulating foot muscles to prevent injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Walking in Minimalist Shoes Is Effective for Strengthening Foot Muscles. Ridge, ST., Olsen, MT., Bruening, DA., et al.[2019]

The novel intrinsic foot muscle (IFM) dynamometer demonstrated moderate-to-excellent reliability for measuring IFM strength in a study of 34 healthy volunteers, making it a promising tool for clinicians.

The dynamometer showed good agreement with a handheld dynamometer, validating its use, and was found to correlate with foot morphology and activity levels, suggesting that these factors may influence IFM strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Intrinsic Foot Muscle Strength Dynamometer Demonstrates Moderate-To-Excellent Reliability and Validity. Xu, J., Goss, DD., Saliba, SA.[2023]

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Strengthening the plantar intrinsic foot muscles might benefit mobility in older adults, which may contribute to the reduction of fall risk.

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Strengthening the plantar intrinsic foot muscles might benefit mobility in older adults, which may contribute to the reduction of fall risk.

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