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RECRUITING Not applicable ClinicalTrials.gov

The Effects of Terrain Variation on Intrinsic Foot Musculature in Healthy Individuals and Individuals With Plantar Fasciitis

Sponsor: University of Florida • ClinicalTrials.gov ID: NCT05075005

Registry updated: 2026-09-10
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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

  • Treatment Cohort (Other)
    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.
  • Control Cohort (Other)
    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.

Eligibility criteria

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 * Age \>18 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 * BMI \>35 * Currently taking or applying any anti-inflammatory medication or medication to control nerve pathology, prescription or over the counter * Third trimester pregnancy

Conditions

Plantar Fasciitis

Locations

  • UF Health Orthopaedics and Sports Medicine Institute — Gainesville, Florida, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record