CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 37 enrolled
Drug / intervention
Home Exercise Program +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06106958
NCT06106958N/ACompleted

The Effects of Foot Rehabilitation And Minimalist Shoes (FRAMES) on Pain, Strength, and Function in Adults With Plantar Fasciopathy

University of Virginia·interventional·Posted Oct 30, 2023·Updated Jul 16, 2025

In Brief

A clinical study evaluating Home Exercise Program and Minimalist Shoes for Plantar Fascitis and 5 related conditions. Completed, enrolled 37 participants across 1 site.

Detailed Summary

The goal of this clinical trial is to compare the effects of 8 weeks of foot rehabilitation exercises in conjunction with wearing minimalist shoes in individuals with plantar fasciopathy, compared to only performing foot rehabilitation exercises. The main questions it aims to answer are: * Will individuals with plantar fasciopathy be able to reduce their pain and improve their self-reported function by performing rehabilitation exercises and wearing minimalist shoes, compared to those only performing rehabilitation exercises? * Will individuals with plantar fasciopathy be able to increase their intrinsic foot muscle strength and size, their balance, and gait biomechanics by performing rehabilitation exercises and wearing minimalist shoes, compared to those only performing rehabilitation exercises? * What characteristics of individuals with plantar fasciopathy make them most suited to succeed in a protocol of performing rehabilitation exercises and wearing minimalist shoes? Participants will be asked to come into the lab at the start of the intervention and after 8 weeks, where the following will be assessed: * Patient-reported outcomes * Foot morphology * Intrinsic foot muscle strength * Balance * Gait biomechanics For the intervention, participants in both groups will perform the same rehabilitation exercises, including: * Massage to the bottom of the foot * Calf-raises * Calf and foot stretches

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedOct 30, 2023
Enrollment StartFeb 14, 2024
Primary CompletionJan 20, 2025
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 2.7 years ago

Interventions

Home Exercise Programbehavioral

Participants will receive a home exercise program that consists of 2 exercises and 3 stretches. The exercises include: * Massage on the bottom of the foot with a ball * Calf-raises * Lunge calf-stretch with the knee straight * Calf-stretch with the knee bent * Stretch for the bottom of the foot These exercises are intended to be performed daily.

Minimalist Shoesbehavioral

Participants will receive a pair of minimalist shoes. They will wear them for an allotted amount of time per day each week, in order to allow for a slow adjustment into the shoes. The protocol is as follows: * Week 1: 1 hour per day * Week 2: 2 hours per day * Week 3: 4 hours per day * Week 4: 6 hours per day * Week 5: 8 hours per day * Week 6: 8 hours per day * Week 7: 8 hours per day * Week 8: 8 hours per day