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Completed

NCT Number: NCT06106958

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

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

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Key information

Conditions

Plantar Fascitis Fasciitis Fasciitis, Plantar Foot Diseases Musculoskeletal Diseases Plantar Fasciitis of Both Feet Plantar Fasciitis of Left Foot Plantar Fasciitis of Right Foot Plantar Fasciitis, Chronic Plantar Fasciopathy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22903, United States

About this study

The purpose of the study is to determine the effects of 8-weeks of wearing minimalist shoes and performing a home exercise program (intervention group) on pain, self-reported function, intrinsic foot muscle strength and size, balance, and gait biomechanics, as opposed to receiving a home exercise program alone (control group).

All participants will report to the Exercise and Sport Injury Laboratory for a baseline clinical assessment performed by a blinded assessor to determine their level of pain and their self-reported function using a variety of patient-reported outcomes. These include pain levels on a Visual Analog Scale (VAS), Global Rating of Change to assess perceived changes in function, Foot Health Status Questionnaire (FHSQ) to gather general and foot-related health information, and a variety of scales that assess kinesiophobia, fear-avoidance belief, self-efficacy, and activity level. Functional measures include intrinsic foot muscle strength via diagnostic ultrasound, intrinsic foot muscle size via two different types of handheld dynamometer, balance via a single-leg balancing task on a force plate, and gait biomechanics via a walking task with insoles that can obtain measures of force and loading rate.

At the end of the first baseline visit, all participants will be taught how to perform the home rehabilitation exercise routine, and handed an informational sheet that will have pictures and links to supplemental videos to ensure that they understand the exercises and have the resources to review.

Immediately following the first baseline visit, participants will meet with another member of the study team to ensure assessor blinding. They will be randomly assigned to one of two groups: the intervention group of foot rehabilitation and minimalist shoes (intervention), or the control group of just rehabilitation exercises (control). The randomization sequence will be created a priori with a random-number generator stratified by sex, placed in sealed opaque envelopes by another member of the study team to blind the assessor. Participants in the intervention group will have a pair of shoes ordered for them, and they will begin the protocol when the shoes have arrived.

Participants in both groups will be instructed to fill out a daily survey that will be sent via text and stored in a secure server (REDCap), that will indicate if they have completed their rehabilitation exercises. Participants will also all wear Fitbit smart watches that will track their step count and some other health-related metrics. They will not be able to see their own data during the protocol.

At the 4-week mark of the study, all individuals will be sent a link to take surveys of patient-reported outcomes, including pain levels, self-reported function, kinesiophobia, fear-avoidance belief, self-efficacy, and activity level. They will also complete a phone call with a member of the study team (not the assessor, to maintain blinding) as a check-in to discuss pain levels and any other questions and concerns they have.

At the end of the 8-weeks, individuals will return to the lab to have the same measures as the baseline session completed. The investigators will then be able to determine if performing foot rehabilitation exercises and wearing minimalist shoes reduces pain, improves self-reported function, and increases intrinsic foot muscle strength and size, balance, and gait biomechanics, compared to baseline and to the control group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between ages of 18 - 55 years old
  • First-step pain in the morning over past week - Visual Analog Score between 30-70 mm
  • Heel pain for at least a month with an insidious onset

Exclusion criteria

  • Other current lower extremity neuromusculoskeletal injury
  • Other lower extremity neuromusculoskeletal injuries other than the foot in the past 3 months
  • Previous history of foot/ankle fractures or surgeries
  • Current participation in formal rehab for plantar fasciopathy
  • Previous minimalist shoe experience

Treatment and study plan

Home Exercise Program

Behavioral

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 Shoes

Behavioral

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

Primary outcomes

  1. Change in Pain

    Time frame: This outcome change will be measured from baseline, to the midpoint of the intervention (4 weeks), to the end of the intervention (8 weeks) for both groups.

    Visual Analog Scale (0-100 mm) pain outcome scores for the following items:

    • Average pain over the past week
    • First-step pain over the past week (the pain that is felt upon waking up in the morning and taking a first step)
    • Average heel pain of the day

  2. Change in perception of overall recovery

    Time frame: This outcome change will be measured from baseline, to the midpoint of the intervention (4 weeks), to the end of the intervention (8 weeks) for both groups.

    Global Rating of Change (GROC) outcome scores

  3. Change in self-reported function and health

    Time frame: This outcome change will be measured from baseline, to the midpoint of the intervention (4 weeks), to the end of the intervention (8 weeks) for both groups.

    Foot Health Status Questionnaire (FHSQ) outcome scores

  4. Change in foot morphology: length, width, arch height, and girth

    Time frame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.

    Arch Height Index tool outcome measures

  5. Change in intrinsic foot muscle size

    Time frame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.

    Muscle thickness and cross-sectional area of the abductor hallucis, flexor hallucis brevis, flexor digitorum brevis, and quadratus plantae, using diagnostic ultrasound in a weight-bearing position.

  6. Change in intrinsic foot muscle strength

    Time frame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.

    Tested separately for the great toe and lesser toes using two different types of handheld dynamometer

  7. Change in center of pressure (COP) distance during balance

    Time frame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.

    COP distance using a force plate during a single-limb balance task, eyes open and eyes closed.

  8. Change in foot posture outcomes

    Time frame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.

    Clinical foot posture index assessment (23-point scale)

  9. Change in center of pressure (COP) velocity during balance

    Time frame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.

    COP velocity using a force plate during a single-limb balance task, eyes open and eyes closed.

  10. Change in center of pressure (COP) 95% ellipse area during balance

    Time frame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.

    COP 95% ellipse area using a force plate during a single-limb balance task, eyes open and eyes closed.

  11. Change in vertical ground reaction force (vGRF) of the rearfoot

    Time frame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.

    The force (N) during treadmill and overground walking using loadsol sensors

Secondary outcomes

  1. Change in kinesiophobia

    Time frame: This outcome change will be measured from baseline, to the midpoint of the intervention (4 weeks), to the end of the intervention (8 weeks) for both groups.

    Tampa Scale of Kinesiophobia (TSK-11) outcome scores

  2. Change in fear-avoidance belief

    Time frame: This outcome change will be measured from baseline, to the midpoint of the intervention (4 weeks), to the end of the intervention (8 weeks) for both groups.

    Fear-Avoidance Belief Questionnaire (FABQ) outcome scores

  3. Change in pain self-efficacy

    Time frame: This outcome change will be measured from baseline, to the midpoint of the intervention (4 weeks), to the end of the intervention (8 weeks) for both groups.

    Pain Self-Efficacy Questionnaire (PSEQ) outcome scores

  4. Change in activity level

    Time frame: This outcome change will be measured from baseline, to the midpoint of the intervention (4 weeks), to the end of the intervention (8 weeks) for both groups.

    National Aeronautics and Space Administration Activity Survey (NAS)

  5. Change in vertical ground reaction force (vGRF) of the whole foot

    Time frame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.

    The force (N) during treadmill and overground walking using loadsol sensors

  6. Change in vertical ground reaction force (vGRF) of the midfoot

    Time frame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.

    The force (N) during treadmill and overground walking using loadsol sensors

  7. Change in vertical ground reaction force (vGRF) of the forefoot

    Time frame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.

    The force (N) during treadmill and overground walking using loadsol sensors

  8. Change in average loading rate

    Time frame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.

    The loading rate (N/s) during treadmill and overground walking using loadsol sensors

  9. Change in instantaneous loading rate

    Time frame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.

    The loading rate (N/s) during treadmill and overground walking using loadsol sensors

  10. Change in knee sagittal plane kinematics

    Time frame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.

    Knee sagittal plane joint moment (in Nm/kg) measured during the overground gait analysis using markerless motion capture

  11. Change in hip sagittal plane kinematics

    Time frame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.

    Hip sagittal plane joint moment (in Nm/kg) measured during the overground gait analysis using markerless motion capture

  12. Change in ankle sagittal plane kinematics

    Time frame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.

    Ankle sagittal plane joint moment (in Nm/kg) measured during the overground gait analysis using markerless motion capture

  13. Change in steps per day

    Time frame: This outcome change will be measured everyday for 8 weeks

    Steps per day measured on a Fitbit

  14. Change in activity level per day

    Time frame: This outcome change will be measured everyday for 8 weeks

    Hours of activity per day measured on a Fitbit

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

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

Acronym: FRAMES

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 30, 2023
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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