Foot Strengthening to Improve Balance and Gait in Older Adults

DEVICE

Minimalist footwear

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

BEHAVIORAL

Foot strengthening exercises

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

DEVICE

ToePro foot strengthening device

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

Change From Baseline in Hallux Flexion Strength (Curl)

Time frame: From enrollment to the end of the intervention at 8 weeks

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.

Change From Baseline in Lesser Toes Flexion Strength (Curl)

Time frame: From enrollment to the end of the intervention at 8 weeks

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.

Change From Baseline in Hallux Flexion Strength (Press)

Time frame: From enrollment to the end of the intervention at 8 weeks

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.

Change From Baseline in Lesser Toe Flexion Strength (Press)

Time frame: From enrollment to the end of the intervention at 8 weeks

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.

Change From Baseline in Gait Kinetic Variables

Time frame: From enrollment to the end of the intervention at 8 weeks

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.

Change From Baseline in Joint Angles during Gait

Time frame: From enrollment to the end of the intervention at 8 weeks

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.

Change From Baseline in Joint Range of Motion During Gait

Time frame: From enrollment to the end of the intervention at 8 weeks

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.

Change From Baseline in Stance Time During Gait

Time frame: From enrollment to the end of the intervention at 8 weeks

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.

Change From Baseline in Step Length During Gait

Time frame: From enrollment to the end of the intervention at 8 weeks

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

Change From Baseline in Cadence During Gait

Time frame: From enrollment to the end of the intervention at 8 weeks

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

Change From Baseline in Step Width During Gait

Time frame: From enrollment to the end of the intervention at 8 weeks

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.

Change From Baseline in 6-Minute Walk Test Distance

Time frame: From enrollment to the end of the intervention at 8 weeks

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

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

Time frame: From enrollment to the end of the intervention at 8 weeks

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.

Change From Baseline in 4-Stage Balance Test Performance

Time frame: From enrollment to the end of the intervention at 8 weeks

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.

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

Time frame: From enrollment to the end of the intervention at 8 weeks

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.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.