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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT05075005
Status
Recruiting
Apply to this trial

Conditions

  • Plantar Fasciitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Jul 15, 2022
Status verified
Aug 2025
Primary completion
Aug 20, 2026
Completion
Aug 20, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Revised Foot Function Index (FFI-R) [ Time Frame: Up to 9 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UF Health Orthopaedics and Sports Medicine InstituteGainesvilleFlorida32611
Aimee M Struk, MEd
[email protected]
352-273-7419
MaryBeth Horodyski, Ed.D.
[email protected]
352-273-7074

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By research site
UF Health Orthopaedics and Sports Medicine Institute· Gainesville, FL

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