Foot Strengthening to Improve Balance and Gait in Older Adults

NCT07384754 | Recruiting FDA Device

• 1 other identifier: 26834, 23946
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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; Foot Strengthening Device (ToePro); Control Condition; Traditional Foot Exercise Program

Keywords

Balance; Gait; Intrinsic Foot Muscles; Minimalist footwear; Aging; Fall prevention

Outcome Measures

Primary Outcomes (15)

• Change From Baseline in Hallux Flexion Strength (Curl)

  Change in maximal hallux (big toe) flexion strength assessed using a standardized hallux curl test (i.e., flexion at the metatarsal interphalangeal joints) with a dynamometer. Participants perform brief maximal voluntary contractions, and peak force output is recorded. Higher values indicate greater hallux curl strength.

  From enrollment to the end of the intervention at 8 weeks

• Change From Baseline in Lesser Toes Flexion Strength (Curl)

  Change in maximal lesser toes flexion strength assessed using a standardized lesser toes curl test (i.e., flexion at the metatarsal interphalangeal joints) with a dynamometer. Participants perform brief maximal voluntary contractions, and peak force output is recorded. Higher values indicate greater lesser toes curl strength.

  From enrollment to the end of the intervention at 8 weeks

• Change From Baseline in Hallux Flexion Strength (Press)

  Change in maximal hallux flexion strength assessed using a toe press test that isolates hallux flexion at the metatarsophalangeal joint. Strength is measured using a force-instrumented platform, with higher values indicating greater hallux press strength.

  From enrollment to the end of the intervention at 8 weeks

• Change From Baseline in Lesser Toe Flexion Strength (Press)

  Change in maximal lesser toes flexion strength assessed using a toe press test that isolates flexion at the metatarsophalangeal joints. Strength is measured using a force-instrumented platform, with higher values indicating greater lesser toes press strength.

  From enrollment to the end of the intervention at 8 weeks

• Change From Baseline in Gait Kinetic Variables

  Change in gait kinetic variables derived from motion capture and force measurement systems during walking. Measures include ground reaction force variables such as peak vertical force. Values reflect loading patterns during gait.

  From enrollment to the end of the intervention at 8 weeks

• Change From Baseline in Joint Angles during Gait

  Change in lower-limb and foot joint angles measured during walking using motion capture. Joint angles are calculated across the gait cycle and represent segmental motion of the foot and lower extremity.

  From enrollment to the end of the intervention at 8 weeks

• Change From Baseline in Joint Range of Motion During Gait

  Change in joint range of motion (ROM) of the foot and lower extremity measured during walking using motion capture. ROM is calculated as the difference between maximum and minimum joint angles during the gait cycle.

  From enrollment to the end of the intervention at 8 weeks

• Change From Baseline in Stance Time During Gait

  Change in stance time measured during walking using motion capture. Stance time represents the duration the foot remains in contact with the ground during each gait cycle.

  From enrollment to the end of the intervention at 8 weeks

• Change From Baseline in Step Length During Gait

  Change in step length measured during walking using motion capture. Step length is defined as the anterior-posterior distance between successive foot contacts.

  From enrollment to the end of the intervention at 8 weeks

• Change From Baseline in Cadence During Gait

  Change in walking cadence measured during gait analysis using motion capture. Cadence is expressed as steps per minute.

  From enrollment to the end of the intervention at 8 weeks

• Change From Baseline in Step Width During Gait

  Change in step width measured during walking using motion capture. Step width reflects the mediolateral distance between foot placements and is used as an indicator of gait stability.

  From enrollment to the end of the intervention at 8 weeks

• Change From Baseline in 6-Minute Walk Test Distance

  Change in distance walked during the 6-Minute Walk Test (6MWT), measured in meters. Greater distance indicates better functional walking capacity.

  From enrollment to the end of the intervention at 8 weeks

• Change From Baseline in 30-Second Sit-to-Stand Test Performance

  Change in functional lower-extremity performance assessed using the 30-Second Sit-to-Stand Test. Outcomes include the total number of completed sit-to-stand repetitions, with higher values indicating better performance.

  From enrollment to the end of the intervention at 8 weeks

• Change From Baseline in 4-Stage Balance Test Performance

  Change in standing balance performance assessed using the 4-Stage Balance Test. Outcomes include the ability to successfully complete progressively challenging standing positions for the required duration.

  From enrollment to the end of the intervention at 8 weeks

• Change From Baseline in Single-Leg Heel-Raise Test Performance

  Change in plantar flexor endurance assessed using the single-leg heel-raise test. Outcomes include the number of consecutive heel raises completed with proper form, with higher values indicating greater muscular endurance.

  From enrollment to the end of the intervention at 8 weeks

Secondary Outcomes (6)

• Change From Baseline in IMU-Derived Gait Acceleration Magnitude

  From enrollment to the end of the intervention at 8 weeks

• Footwear Minimalism (Minimalist Index)

  Baseline

• Intervention Compliance Survey Responses

  Throughout the 8-week intervention period

• FitBit-Derived Moderate-to-Vigorous Physical Activity (MVPA)

  Throughout the 8-week intervention period

• Change From Baseline in International Physical Activity Questionnaire (IPAQ) Scores

  From enrollment to the end of the intervention at 8 weeks

Study Arms (4)

Minimalist footwear

EXPERIMENTAL

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

Device: Minimalist footwear

Control

NO INTERVENTION

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

Foot strengthening device (ToePro)

ACTIVE COMPARATOR

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

Device: ToePro foot strengthening device

Foot exercise program

EXPERIMENTAL

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

Behavioral: Foot strengthening exercises

Interventions

Minimalist footwear DEVICE

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

Minimalist footwear

Foot strengthening exercises BEHAVIORAL

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

Foot exercise program

ToePro foot strengthening device DEVICE

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

Foot strengthening device (ToePro)

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

School of Public Health-Bloomington

Bloomington, Indiana, 47405, United States

RECRUITING

Study Officials

• Allison H. Gruber, PhD

  Indiana University, Bloomington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marni Wasserman, MS

CONTACT

812-856-2447; marnwass@iu.edu

Allison H. Gruber, PhD

CONTACT

812-856-2447; ahgruber@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 3, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

US (1)