Minimalist FootwearNCT07384754
Foot Strengthening to Improve Balance and Gait in Older Adults
A study testing Minimalist footwear, Foot strengthening exercises and ToePro foot strengthening device in people with Minimalist Footwear and Traditional Foot Exercise Program, run by Indiana University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Minimalist Footwear, Traditional Foot Exercise Program, Foot Strengthening Device (ToePro)
- What is being tested?
- Minimalist footwear, Foot strengthening exercises and ToePro foot strengthening device
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults: 45 years of age or older
- Able to walk without an assistive walking device or lower limb prosthesis for at least 6 minutes
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
School of Public Health-Bloomington
Bloomington, Indiana, 47405
About this study
Official title: Evaluation of a Novel Foot Strengthening Device for Improving Fall Risk, Balance, and Gait With Age
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:
Read more
- 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
Read the detailed description
This randomized controlled trial evaluates the effects of multiple foot-strengthening interventions on foot strength, balance, gait, and fall-related outcomes in older adults. 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.
- Conditions
- Minimalist Footwear, Traditional Foot Exercise Program, Foot Strengthening Device (ToePro), Control Condition
- Being tested
- Minimalist footwear, Foot strengthening exercises, ToePro foot strengthening device
- Keywords
- Balance, Gait, Intrinsic Foot Muscles, Minimalist footwear, Aging, Fall prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimalist footwearDevice
Habitual use of low-cushion, low-structure footwear designed to increase intrinsic foot muscle engagement during daily activities.
Foot strengthening exercisesBehavioural
Home-based exercises including toe flexion, toe press, and arch-control movements performed several times per week.
ToePro foot strengthening deviceDevice
A dense foam exercise platform designed to strengthen intrinsic foot muscles through loaded toe press exercises in lengthened muscle positions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Foot strengthening exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of the intervention at 8 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of the intervention at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start21 Oct 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimalist FootwearStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Gruber, PhD, Indiana University
- Investigators
- Allison H. Gruber, PhD, Principal investigator, Indiana University, Bloomington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384754
- Sponsor's protocol ID
- 26834, 23946
- Status last verified
- Aug 2026
- First submitted
- 20 Jan 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Foot Strengthening Device for Improving Fall Risk, Balance, and Gait With Age
- ClinicalTrials.gov ID
- NCT07384754
- Acronym / sponsor ID
- 26834, 23946
- Conditions
- Minimalist Footwear, Traditional Foot Exercise Program, Foot Strengthening Device (ToePro), Control Condition
- Keywords
- Balance, Gait, Intrinsic Foot Muscles, Minimalist footwear, Aging, Fall prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 older adults. 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Minimalist footwear | Experimental | Device: Minimalist footwearParticipants are instructed to wear minimalist footwear during activities of daily living for 8 weeks, progressively increasing wear time according to a standardized schedule. |
| Control | No intervention | –Participants do not receive any foot-strengthening intervention and continue usual activities. |
| Foot strengthening device (ToePro) | Active comparator | Device: ToePro foot strengthening deviceParticipants use a commercially available foot-strengthening device (ToePro) for a prescribed exercise protocol over 8 weeks. |
| Foot exercise program | Experimental | Behavioral: Foot strengthening exercisesParticipants complete a prescribed foot and ankle strengthening exercise program targeting intrinsic and extrinsic foot muscles over an 8-week period. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy adults: 45 years of age or older
- Able to walk without an assistive walking device or lower limb prosthesis for at least 6 minutes
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimalist footwearHabitual use of low-cushion, low-structure footwear designed to increase intrinsic foot muscle engagement during daily activities. | Device | Minimalist footwear |
| Foot strengthening exercisesHome-based exercises including toe flexion, toe press, and arch-control movements performed several times per week. | Behavioural | Foot exercise program |
| ToePro foot strengthening deviceA dense foam exercise platform designed to strengthen intrinsic foot muscles through loaded toe press exercises in lengthened muscle positions. | Device | Foot strengthening device (ToePro) |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Minimalist Footwear
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allison H. Gruber, PhD principal investigator
Indiana University, Bloomington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimalist footwear, Foot strengthening exercises and ToePro foot strengthening device in people with Minimalist Footwear and Traditional Foot Exercise Program, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marni Wasserman, MS (812-856-2447, marnwass@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Hallux Flexion Strength (Curl) (time frame: From enrollment to the end of the intervention at 8 weeks). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.