What this study is
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.
What's being tested
- Treatment Cohort
Intervention · 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
Intervention · 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
- Official title
- A Randomized Control Trial Studying the Effects of Terrain Variation on Intrinsic Foot Musculature in Healthy Individuals and Individuals With Plantar Fasciitis:
- Sponsor
- University of Florida
- Conditions
- Plantar Fasciitis
- Enrolling
- 60 people
- Starts
- 2024-09-15
- Est. completion
- 2027-01-20
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 100 YearsSex ALLHealthy volunteers AcceptedGroup A
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
You can't join 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
Group B
You may qualify if
- Healthy individuals in the general population of Gainesville and surrounding areas
- Age >18
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUF Health Orthopaedics and Sports Medicine Institute
Gainesville, Florida, United States
- Aimee M Struk, MEd · Contact352-273-7419strukam@ortho.ufl.edu
- MaryBeth Horodyski, Ed.D. · Contact352-273-7074horomb@ortho.ufl.edu
Recruiting
Study team
Sponsor
University of Florida
Study ID IRB202100081
Principal investigator
Antony Merendino, DPM
University of Florida
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.