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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

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

Intervention / Treatment
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* Behavioral: Home Exercise Program
* Behavioral: Minimalist Shoes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There will be two groups: Performing foot rehabilitation exercises and wearing minimalist shoes (intervention group) Only performing foot rehabilitation exercises (control group)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Foot Rehabilitation And Minimalist Shoes (FRAMES)<br>The intervention group will receive a pair of minimalist shoes along with a home exercise program and a protocol that indicates how to slowly adjust to wearing the shoes. | Behavioral: Home Exercise Program<br>* 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.<br>Behavioral: Minimalist Shoes<br>* 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<br>|
| Active Comparator: Home Exercise Program (Control)<br>The intervention group will receive a home exercise program. | Behavioral: Home Exercise Program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain | 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 | 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. | 
| Change in perception of overall recovery | Global Rating of Change (GROC) outcome scores | 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. | 
| Change in self-reported function and health | Foot Health Status Questionnaire (FHSQ) outcome scores | 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. | 
| Change in foot morphology: length, width, arch height, and girth | Arch Height Index tool outcome measures | This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups. | 
| Change in intrinsic foot muscle size | 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. | This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups. | 
| Change in intrinsic foot muscle strength | Tested separately for the great toe and lesser toes using two different types of handheld dynamometer | This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups. | 
| Change in center of pressure (COP) distance during balance | COP distance using a force plate during a single-limb balance task, eyes open and eyes closed. | This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups. | 
| Change in foot posture outcomes | Clinical foot posture index assessment (23-point scale) | This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups. | 
| Change in center of pressure (COP) velocity during balance | COP velocity using a force plate during a single-limb balance task, eyes open and eyes closed. | This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups. | 
| Change in center of pressure (COP) 95% ellipse area during balance | COP 95% ellipse area using a force plate during a single-limb balance task, eyes open and eyes closed. | This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups. | 
| Change in vertical ground reaction force (vGRF) of the rearfoot | The force (N) during treadmill and overground walking using loadsol sensors | This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in kinesiophobia | Tampa Scale of Kinesiophobia (TSK-11) outcome scores | 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. | 
| Change in fear-avoidance belief | Fear-Avoidance Belief Questionnaire (FABQ) outcome scores | 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. | 
| Change in pain self-efficacy | Pain Self-Efficacy Questionnaire (PSEQ) outcome scores | 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. | 
| Change in activity level | National Aeronautics and Space Administration Activity Survey (NAS) | 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. | 
| Change in vertical ground reaction force (vGRF) of the whole foot | The force (N) during treadmill and overground walking using loadsol sensors | This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups. | 
| Change in vertical ground reaction force (vGRF) of the midfoot | The force (N) during treadmill and overground walking using loadsol sensors | This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups. | 
| Change in vertical ground reaction force (vGRF) of the forefoot | The force (N) during treadmill and overground walking using loadsol sensors | This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups. | 
| Change in average loading rate | The loading rate (N/s) during treadmill and overground walking using loadsol sensors | This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups. | 
| Change in instantaneous loading rate | The loading rate (N/s) during treadmill and overground walking using loadsol sensors | This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups. | 
| Change in knee sagittal plane kinematics | Knee sagittal plane joint moment (in Nm/kg) measured during the overground gait analysis using markerless motion capture | This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups. | 
| Change in hip sagittal plane kinematics | Hip sagittal plane joint moment (in Nm/kg) measured during the overground gait analysis using markerless motion capture | This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups. | 
| Change in ankle sagittal plane kinematics | Ankle sagittal plane joint moment (in Nm/kg) measured during the overground gait analysis using markerless motion capture | This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups. | 
| Change in steps per day | Steps per day measured on a Fitbit | This outcome change will be measured everyday for 8 weeks | 
| Change in activity level per day | Hours of activity per day measured on a Fitbit | This outcome change will be measured everyday for 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plantar fasciitis, intrinsic foot muscles, minimalist shoes