Foot Strengthening to Improve Balance and Gait in Older Adults

Official title

Evaluation of a Novel Foot Strengthening Device for Improving Fall Risk, Balance, and Gait With Age

Overview

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

Detailed 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.

Interventions

• 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.

Primary outcome measures

• Change From Baseline in Hallux Flexion Strength (Curl) [Time frame: From enrollment to the end of the intervention at 8 weeks]
• Change From Baseline in Lesser Toes Flexion Strength (Curl) [Time frame: From enrollment to the end of the intervention at 8 weeks]
• Change From Baseline in Hallux Flexion Strength (Press) [Time frame: From enrollment to the end of the intervention at 8 weeks]
• Change From Baseline in Lesser Toe Flexion Strength (Press) [Time frame: From enrollment to the end of the intervention at 8 weeks]
• Change From Baseline in Gait Kinetic Variables [Time frame: From enrollment to the end of the intervention at 8 weeks]
• Change From Baseline in Joint Angles during Gait [Time frame: From enrollment to the end of the intervention at 8 weeks]
• Change From Baseline in Joint Range of Motion During Gait [Time frame: From enrollment to the end of the intervention at 8 weeks]
• Change From Baseline in Stance Time During Gait [Time frame: From enrollment to the end of the intervention at 8 weeks]
• Change From Baseline in Step Length During Gait [Time frame: From enrollment to the end of the intervention at 8 weeks]
• Change From Baseline in Cadence During Gait [Time frame: From enrollment to the end of the intervention at 8 weeks]

Secondary outcome measures (6)

• Change From Baseline in IMU-Derived Gait Acceleration Magnitude [Time frame: From enrollment to the end of the intervention at 8 weeks]
• Footwear Minimalism (Minimalist Index) [Time frame: Baseline]
• Intervention Compliance Survey Responses [Time frame: Throughout the 8-week intervention period]
• FitBit-Derived Moderate-to-Vigorous Physical Activity (MVPA) [Time frame: Throughout the 8-week intervention period]
• Change From Baseline in International Physical Activity Questionnaire (IPAQ) Scores [Time frame: From enrollment to the end of the intervention at 8 weeks]
• Change From Baseline in Sedentary Behavior Questionnaire (SBQ) Scores [Time frame: From enrollment to the end of the intervention at 8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• School of Public Health-Bloomington — Bloomington

Identifiers

NCT: NCT07384754 · 26834, 23946

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗