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Minimal Shoes and Exercises for Plantar Fasciitis (NAPA Trial)

Phase 2
Recruiting
Research Sponsored by University of South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Heel/arch pain with prolonged walking (>15 min)
Active plantar fasciitis for a minimum of 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

"This trial aims to see if foot exercises and minimal footwear can help older adults with foot pain. Participants will be split into two groups - one with minimal shoes and exercises, and the other with supportive shoes

Who is the study for?
This trial is for aging adults who've had active plantar fasciitis for at least 6 months and experience heel or arch pain in the morning, with prolonged standing or walking. Participants should be able to stand and walk for 10 minutes with minimal pain.
What is being tested?
The study compares two approaches: one group will use minimal shoes combined with foot strengthening and flexibility exercises; the other will wear supportive footwear with orthotic devices and do flexibility exercises. Their step count and improvements in pain and function are monitored.
What are the potential side effects?
Potential side effects may include increased foot pain, discomfort while adjusting to new footwear or exercise routines, skin irritation from orthotics or shoes, muscle soreness from exercises, and possible injury due to changes in gait.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I experience heel or arch pain after walking more than 15 minutes.
Select...
I have had plantar fasciitis for at least 6 months.
Select...
I can stand and walk for 10 minutes with minimal pain.
Select...
I experience heel or arch pain after standing for more than 15 minutes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Foot Health Status Questionnaire (FHSQ)
Foot pain
Global Rating Outcome Change (GROC)
+2 more
Secondary study objectives
International Physical Activity Questionnaire (IPAQ)
Muscle Strength
Muscles size of cross sectional area
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Minimal Footwear (Vivobarefoot)Experimental Treatment1 Intervention
The experimental intervention involves the combination of foot strengthening/stretching and minimal footwear to promote the foot strengthening beyond the exercise program to mitigate weakening from chronic support.
Group II: Supportive FootwearActive Control1 Intervention
The control intervention is considered the standard of care and involves combination of foot stretching and the addition of supportive shoes and foot orthoses.

Find a Location

Who is running the clinical trial?

University of HartfordOTHER
13 Previous Clinical Trials
455 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,865 Total Patients Enrolled
University of South FloridaLead Sponsor
422 Previous Clinical Trials
189,089 Total Patients Enrolled
~53 spots leftby May 2025
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