NCT05075005 · University of Florida
The Effects of Terrain Variation on Intrinsic Foot Musculature in Healthy Individuals and Individuals With Plantar Fasciitis
What this study is about
Modern footwear has been implicated as a contributor to foot pathology and changes in the biomechanics of gait. In addition to footwear, the investigators propose that the lack of terrain variation may directly contribute to the development of common foot pathologies, resulting from decreased intrinsic foot muscle function.
View original scientific description
Modern footwear has been implicated as a contributor to foot pathology and changes in the biomechanics of gait. In addition to footwear, the investigators propose that the lack of terrain variation may directly contribute to the development of common foot pathologies, resulting from decreased intrinsic foot muscle function. This study will examine the current understanding of terrain variation on foot musculature strength and its possible correlation with structural and functional changes within the foot.
Interventions
OTHER
Treatment Cohort
Subjects will walk on a specified University of Florida Natural Area Teaching Laboratory's (NATL) nature trail for approximately 30 minutes, three times per week for 8 weeks while wearing the minimalist shoes provided by the study team. Time, distance, and GPS walking route will be recorded utilizing the MapMyRun smartphone application, which is free to download and easy to use. The study team will assist each subject with downloading the application onto their smartphone and provide a brief training on app use at their pre-trial visit. Subjects will be asked to save each training session within the app to report to the study team upon completion of the 8-week training protocol. Subjects will be instructed to walk at a comfortable pace and to stop if they begin experiencing increased pain or discomfort.
OTHER
Control Cohort
Subjects will walk on hardscapes (e.g. sidewalk, asphalt, track, etc) for approximately 30 minutes, three times per week for 8 weeks while wearing the minimalist shoes provided by the study team. Similarly to the treatment group, subjects will be asked to utilize the MapMyRun smartphone application to record their training sessions. Subjects will be instructed to walk at a comfortable pace and to stop if they begin experiencing increased pain or discomfort.
Primary outcome measures
Revised Foot Function Index (FFI-R)
Time frame: Up to 9 weeks
34 questions rated on a scale from 1 to 4, will be used to evaluate change in overall foot function, foot health, and quality of life at trial onset, at the end of each week throughout the training protocol and upon completion of the training protocol (total of 9 times).
Visual Analog Scale (VAS)
Time frame: Up to 9 weeks
Zero millimeters on the VAS corresponds to 'no pain,' while 100 millimeters on the VAS corresponds to 'worst pain imaginable.' The participant will be asked to draw a vertical line perpendicular to the VAS line at the point that depicts their pain intensity on average throughout the week. The distance from the zero millimeter line to the participant's vertical mark will be measured to yield a score that ranges from 0 to 100. The change in these measurements is being assessed at the end of each week of the training protocol and upon completion of the training protocol (total of 9 times).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- for Group A:
- Patients presenting to the University of Florida Orthopaedics and Sports Medicine Institute with pain on the plantar medial or central heel for greater than 60 days with the following features
- Pain upon palpation, or insidious pain onset
- Pain accentuated after long periods of weight bearing activities or after periods of rest
- A reduction in pain following light activities (McPoil et al., 2008)
- Failure to respond to treatment modalities for 6 months, including plantar fascia and muscle stretching, nonsteroidal anti-inflammatory medication, supportive insoles, and night splints
- Age \>18 years Inclusion Criteria for Group B:
- Healthy individuals in the general population of Gainesville and surrounding areas
Exclusion criteria
- for Group A:
- History of lower leg or foot surgery, hindfoot trauma or fracture of the affected limb within the previous year.
- Diagnosis of diabetic neuropathy, fibromyalgia, neurological disease, Achilles tendinopathy, metatarsalgia, tarsal tunnel syndrome or heel pad syndrome
- Body Mass Index (BMI) \> 35
- Currently taking or applying any anti-inflammatory medication or medication to control nerve pathology, prescription or over the counter
- Third trimester pregnancy Exclusion Criteria for Group B:
- Any foot or lower limb pathology resulting in discomfort or gait limitation
- Diagnosis of diabetic neuropathy, fibromyalgia, neurological disease
- Currently taking or applying any anti-inflammatory medication or medication to control nerve pathology, prescription or over the counter
- Third trimester pregnancy
Where
- Gainesville, Florida
Related conditions & keywords
Frequently asked questions
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.
Data: ClinicalTrials.gov · synced Aug 28, 2025 · Source of record for eligibility and locations