Foot Strengthening to Improve Balance and Gait in Older Adults

Indiana University

Status: Enrolling

Conditions: Traditional Foot Exercise Program; Minimalist Footwear; Control Condition; Foot Strengthening Device (ToePro)

Treatments: Device: Minimalist footwear; Device: ToePro foot strengthening device; Behavioral: Foot strengthening exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT07384754

26834, 23946

Details and patient eligibility

About

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

Full description

This randomized controlled trial evaluates the effects of multiple foot-strengthening interventions on foot strength, balance, gait, and fall-related outcomes in adults aged 45-85 years. Participants are recruited using a unified screening process and randomized to one of several intervention arms across two coordinated protocols. Interventions include habitual use of minimalist footwear, a prescribed foot exercise program, use of a commercially available foot-strengthening device (ToePro), or a no-intervention control condition.

All participants complete two in-laboratory data collection sessions conducted at baseline and after an 8-week intervention period. Laboratory assessments include measurements of foot morphology, intrinsic and extrinsic foot muscle strength, standing balance, physical function, and walking gait. Participants also complete standardized questionnaires assessing physical activity, balance confidence, fall history, and foot health. A follow-up questionnaire assessing physical activity, footwear use, foot health, and falls is administered six months after the intervention period.

During the 8-week intervention period, participants assigned to an active intervention are instructed to follow standardized intervention protocols specific to their assigned group. Physical activity levels during the intervention period are monitored for all groups using wearable activity tracking devices that record metrics such as daily step count and time spent in moderate-to-vigorous physical activity. These data are used to characterize habitual physical activity during the intervention period and to account for potential differences in overall activity levels between groups.

Intervention compliance is monitored throughout the 8-week period using self-reported compliance surveys. Participants report adherence to assigned footwear use, exercise sessions, or device use according to their intervention group. Compliance data are used to quantify adherence to the prescribed intervention protocols and to support interpretation of intervention effects.

Data from both protocols are pooled to allow direct comparison of the effects of different foot-strengthening strategies on foot strength, balance, gait, and fall-related outcomes in middle-aged and older adults.

Enrollment: 160 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults: age 45-85 years old
• Able to walk without an assistive walking device or lower limb prosthesis
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 4 patient groups

Minimalist footwear

Experimental group

Description:

Participants are instructed to wear minimalist footwear during activities of daily living for 8 weeks, progressively increasing wear time according to a standardized schedule.

Treatment:

Device: Minimalist footwear

Control

No Intervention group

Description:

Participants do not receive any foot-strengthening intervention and continue usual activities.

Foot strengthening device (ToePro)

Active Comparator group

Description:

Participants use a commercially available foot-strengthening device (ToePro) for a prescribed exercise protocol over 8 weeks.

Treatment:

Device: ToePro foot strengthening device

Foot exercise program

Experimental group

Description:

Participants complete a prescribed foot and ankle strengthening exercise program targeting intrinsic and extrinsic foot muscles over an 8-week period.

Treatment:

Behavioral: Foot strengthening exercises