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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimalist footwear | Device | Habitual use of low-cushion, low-structure footwear designed to increase intrinsic foot muscle engagement during daily activities. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in IMU-Derived Gait Acceleration Magnitude | Change in gait acceleration magnitude measured using an inertial measurement unit (IMU) during walking assessments. Acceleration magnitude is derived from tri-axial accelerometer signals and reflects overall movement intensity during gait. | From enrollment to the end of the intervention at 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marni Wasserman, MS | Contact | 812-856-2447 | marnwass@iu.edu | |
| Allison H. Gruber, PhD | Contact | 812-856-2447 | ahgruber@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Allison H. Gruber, PhD | Indiana University, Bloomington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Public Health-Bloomington | Recruiting | Bloomington | Indiana | 47405 | United States |
At this time, the plan for sharing individual participant data (IPD) from this study has not been finalized. Decisions regarding IPD sharing will be informed by ongoing discussions among the study team and institutional policies. Before a specific data sharing plan can be confirmed, the study team must establish appropriate procedures to ensure participant privacy and confidentiality in accordance with institutional review board (IRB) requirements.
Additional considerations include determining suitable methods for data de-identification, defining the scope of data and supporting documentation that could be shared, and identifying appropriate data access mechanisms that support responsible use by qualified researchers. Once these considerations have been addressed, an IPD sharing plan - including the data elements to be shared, timing of availability, and access criteria - will be finalized and made publicly available.
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| Foot strengthening exercises | Behavioral | Home-based exercises including toe flexion, toe press, and arch-control movements performed several times per week. |
|
| 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. |
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| 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 |
| Footwear Minimalism (Minimalist Index) | Footwear minimalism assessed using the Minimalist Index (MI) rating scale applied to participants' commonly worn footwear. Higher scores indicate greater footwear minimalism. | Baseline |
| Intervention Compliance Survey Responses | Participant-reported adherence to the assigned intervention assessed using standardized, electronic compliance surveys. Survey items quantify frequency and duration of prescribed footwear use, exercise sessions, or device use during the intervention period. Higher values indicate greater adherence to the assigned intervention protocol. | Throughout the 8-week intervention period |
| FitBit-Derived Moderate-to-Vigorous Physical Activity (MVPA) | Moderate-to-vigorous physical activity (MVPA) assessed using a wearable activity tracker (FitBit) during the intervention period. MVPA is quantified as minutes per day spent in moderate-to-vigorous intensity activity, summarized across the intervention period. Higher values indicate greater engagement in MVPA. | Throughout the 8-week intervention period |
| Change From Baseline in International Physical Activity Questionnaire (IPAQ) Scores | Change in self-reported physical activity assessed using the International Physical Activity Questionnaire (IPAQ). Outcomes include estimated time spent in physical activity at different intensity levels. | From enrollment to the end of the intervention at 8 weeks |
| Change From Baseline in Sedentary Behavior Questionnaire (SBQ) Scores | Change in self-reported sedentary behavior assessed using the Sedentary Behavior Questionnaire (SBQ). Outcomes include time spent in sedentary activities across multiple daily contexts. | From enrollment to the end of the intervention at 8 weeks |