- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05075005
The Effects of Terrain Variation on Intrinsic Foot Musculature in Healthy Individuals and Individuals With Plantar Fasciitis
A Randomized Control Trial Studying the Effects of Terrain Variation on Intrinsic Foot Musculature in Healthy Individuals and Individuals With Plantar Fasciitis:
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Human foot is one or the most complicated structures in the conveyance of normal gait, with its 26 bones, 33 articulations, 19 individual intrinsic muscles and direct contribution from all of the lower leg musculature. It also contains a complexity of ligamentous structures that not only act as stabilizers, but also store and release energy in a spring like fashion (Ker 1987). This group of anatomical structures is modulated by a complex system of mechanoreceptors that allow for adaptation to a multitude of varying terrain, while maintaining stability and control. (Franklin 2018) Thus the investigators see the structural, spring and muscular systems all coordinating together to allow for bipedal gait through the natural world.
Multiple observational studies have found an exceptionally low prevalence of common foot pathologies in unshod populations that ambulate on variable terrain daily (Shulman, Choi). At the same time, these same pathologies have become increasingly common in western societies. These findings suggest that something about the western lifestyle is contributing to the development of common foot pathologies. Modern footwear has already been implicated as a contributor to foot pathology and changes in the biomechanics of gait. In a study by K. D'AoÛt et al. on an unshod vs shod Indian population, they found that barefoot walkers had a more equal distribution of peak pressures over the entire load carrying surface than in the habitually shod subjects. The shod subjects had regions of very high or very low peak pressures throughout the load carrying surface.
The increase prevalence of foot pain in the developed world has long been recognized as a significant risk factor for ambulatory disability, (Hill, C. 2008) with plantar fasciitis and hallux valgus being two of the most common causes of foot discomfort presenting in the clinical setting today. Plantar fasciitis accounts for approximately 13% of all foot symptoms requiring professional medical treatment and is believed to be the result of weakening of the intrinsic foot musculature and chronic overload to the plantar foot supportive structure. (Buchanan, B. 2020). Intrinsic foot muscle function seems to play and import role in the development of foot pathology, and is one of the key factors effecting foot health.
The lack of terrain variation found in urbanized western society may directly contribute to the development of foot pathologies. Terrain variation in a minimally shod foot should allow for more coordination and strengthening of the muscular and spring like systems within the foot, through the increase and variation of stimuli encountered by its mechanoreceptors. Lack of terrain variation most probably contributes to a decreased intrinsic foot muscle function and response. There have been many studies showing the correlation between improved intrinsic foot musculature strength and the reduction of foot pain and discomfort, but to date, there are no studies that examined the relationship between terrain variation and intrinsic foot muscle function and strength.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Antony Merendino, DPM
- Phone Number: 352-273-7198
- Email: merena@ortho.ufl.edu
Study Contact Backup
- Name: Alex Barnett, MS
- Phone Number: 352-273-7337
- Email: barneam@ortho.ufl.edu
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32611
- Recruiting
- UF Health Orthopaedics and Sports Medicine Institute
-
Contact:
- Aimee M Struk, MEd
- Phone Number: 352-273-7419
- Email: strukam@ortho.ufl.edu
-
Contact:
- MaryBeth Horodyski, Ed.D.
- Phone Number: 352-273-7074
- Email: horomb@ortho.ufl.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
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.
|
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Revised Foot Function Index (FFI-R)
Time Frame: Up to 9 weeks
|
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)
Time Frame: Up to 9 weeks
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Antony Merendino, DPM, University of Florida
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB202100081
- OCR40929 (Other Identifier: UF OnCore)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Plantar Fasciitis
-
University of VirginiaRecruitingPlantar Fascitis | Plantar Fasciopathy | Plantar Fasciitis, Chronic | Plantar Fasciitis of Both Feet | Plantar Fasciitis of Right Foot | Plantar Fasciitis of Left FootUnited States
-
Cairo UniversityNot yet recruiting
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...RecruitingPlantar FascitisItaly
-
Chinese University of Hong KongRecruiting
-
Istanbul Medeniyet UniversityNot yet recruiting
-
Chinese University of Hong KongRecruitingPlantar FascitisHong Kong
-
Stanford UniversityNot yet recruitingPlantar Fascitis
-
Hospital for Special Surgery, New YorkActive, not recruiting
-
Riphah International UniversityCompletedPlantar FascitisPakistan
-
Universidad Complutense de MadridUnknownPlantar Fasciitis | Ultrasound Therapy | Plantar Fasciitis, ChronicSpain
Clinical Trials on Treatment Cohort
-
Cerenovus, Part of DePuy Synthes Products, Inc.Active, not recruitingChronic Subdural HematomaUnited States
-
Centro Hospitalar NordesteCompletedColorectal Cancer
-
Sucampo Pharma Americas, LLCTakedaCompletedHealthy VolunteersUnited States
-
New Mexico Cancer Care AllianceCompleted
-
Y Biologics Inc.Novotech (Australia) Pty LimitedActive, not recruitingAdvanced Solid TumorsKorea, Republic of, Thailand, Australia
-
Institut du Cancer de Montpellier - Val d'AurelleNot yet recruiting
-
Kangabio AUSTRALIA LTD PTYNot yet recruitingAdvanced or Metastatic Solid TumorsAustralia
-
XOMA (US) LLCCompletedCongenital HyperinsulinismUnited Kingdom, United States
-
MedImmune LLCCompletedHealthyUnited States, Australia, Spain, Germany, Canada, Finland, South Africa, Brazil, Israel
-
AstraZenecaActive, not recruitingCOVID-19, SARS-CoV-2Japan