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

NCT05075005 | Recruiting

• 2 other identifiers: IRB202100081OCR40929
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Plantar Fasciitis

Outcome Measures

Primary Outcomes (2)

• Revised Foot Function Index (FFI-R)

  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).

  Up to 9 weeks

• Visual Analog Scale (VAS)

  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).

  Up to 9 weeks

Study Arms (2)

Treatment Cohort

ACTIVE COMPARATOR

Treatment Cohort: Will utilize a minimalist shoe (Vibram® Fivefingers) and follow the training protocol described below for training on natural terrain.

Other: Treatment Cohort; Other: Control Cohort

Control Cohort

EXPERIMENTAL

Control Cohort: Will utilize the same minimalist shoe and follow the same training schedule as the treatment group, with the modification of training on hardscapes.

Other: Treatment Cohort; Other: Control Cohort

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; Treatment Cohort

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.

Control Cohort; Treatment Cohort

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Healthy individuals in the general population of Gainesville and surrounding areas
• Age \>18

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32611, United States

RECRUITING

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Antony Merendino, DPM

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antony Merendino, DPM

CONTACT

352-273-7198; merena@ortho.ufl.edu

Shea Herlihy, MS

CONTACT

352-273-7361; herliso@ortho.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, randomized control trial of patients randomly assigned to one of two groups

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: October 12, 2021
• Study Start: July 15, 2022
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)