Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
Healthy Volunteers
ID05075005

A Randomized Control Trial Studying the Effects of Terrain Variation on Intrinsic Foot Musculature in Healthy Individuals and Individuals With Plantar Fasciitis

Led by University of Florida · Updated on 2025-08-28

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to explore how walking on different types of terrain affects the strength and function of the small muscles inside the foot. It focuses on both healthy individuals and those with plantar fasciitis, a common foot condition causing heel pain. The study is based on observations that people who walk barefoot on varied natural surfaces tend to have fewer foot problems compared to those in modern societies who wear shoes and walk mostly on flat surfaces. Participants are divided into two groups. One group will walk on a natural trail wearing minimalist shoes called Vibram Fivefingers, while the other group will wear the same shoes but walk on hard surfaces like sidewalks or tracks. Both groups will follow a training schedule of about 30 minutes per session, three times a week, for eight weeks. Participants will use a smartphone app to track their walking time, distance, and routes. During the study, researchers will assess foot function and pain using tools like the Revised Foot Function Index and a Visual Analog Scale over a period of up to nine weeks. Participants will be monitored for any changes in their foot muscle strength and discomfort. The study includes adults aged 18 to 100 years and involves regular tracking of walking sessions and pain levels to understand the effects of terrain variation on foot health.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • For Group A: Patients with heel pain lasting more than 60 days with pain on palpation or insidious onset
  • Pain worsens after long periods of standing or rest and improves after light activity
  • Failure to improve after 6 months of treatments like stretching, anti-inflammatory medication, insoles, or night splints
  • For Group B: Healthy individuals without foot pain
  • Ability to use the MapMyRun smartphone application for tracking walking sessions
Not Eligible

You will not qualify if you...

  • History of foot or lower leg surgery, trauma, or fracture in the past year for Group A
  • Diagnosed diabetic neuropathy, fibromyalgia, neurological disease, Achilles tendinopathy, metatarsalgia, tarsal tunnel syndrome, or heel pad syndrome for Group A
  • For both groups: Body Mass Index (BMI) over 35
  • Current use of anti-inflammatory medications or medications for nerve conditions
  • Third trimester pregnancy
  • For Group B: Any foot or lower limb condition causing discomfort or difficulty walking

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants walk approximately 30 minutes, three times per week for 8 weeks wearing minimalist shoes while walking on either natural terrain or hard surfaces depending on their assigned group. They will use a smartphone application to record their walking sessions and stop if they experience increased pain or discomfort.

Three walking sessions per week with app tracking

Trial Site Locations

Total: 1 location

1

UF Health Orthopaedics and Sports Medicine Institute

Gainesville, Florida, United States, 32611

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Research Team

A

Antony Merendino, DPM

S

Shea Herlihy, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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