Clinical trial NCT06106958: Effects of Foot Rehabilitation And Minimalist Shoes on Pain, Strength, and Function in Adults With Plantar Fasciopathy
Official title: The Effects of Foot Rehabilitation And Minimalist Shoes (FRAMES) on Pain, Strength, and Function in Adults With Plantar Fasciopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Plantar Fascitis
Plantar Fasciopathy
Plantar Fasciitis of Both Feet
Plantar Fasciitis of Right Foot
Plantar Fasciitis of Left Foot
Plantar Fasciitis, Chronic
Keywords: plantar fasciitis
intrinsic foot muscles
minimalist shoes
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two groups:

1. Performing foot rehabilitation exercises and wearing minimalist shoes (intervention group)
2. Only performing foot rehabilitation exercises (control group)
Primary purpose: TREATMENT

Brief 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain
timeFrame: 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.
measure: Change in perception of overall recovery
timeFrame: 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.
measure: Change in self-reported function and health
timeFrame: 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.
measure: Change in foot morphology: length, width, arch height, and girth
timeFrame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.
measure: Change in intrinsic foot muscle size
timeFrame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.
measure: Change in intrinsic foot muscle strength
timeFrame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.
measure: Change in center of pressure (COP) distance during balance
timeFrame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.
measure: Change in foot posture outcomes
timeFrame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.
measure: Change in center of pressure (COP) velocity during balance
timeFrame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.
measure: Change in center of pressure (COP) 95% ellipse area during balance
timeFrame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.
measure: Change in vertical ground reaction force (vGRF) of the rearfoot
timeFrame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.
Secondary outcomes:
measure: Change in kinesiophobia
timeFrame: 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.
measure: Change in fear-avoidance belief
timeFrame: 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.
measure: Change in pain self-efficacy
timeFrame: 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.
measure: Change in activity level
timeFrame: 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.
measure: Change in vertical ground reaction force (vGRF) of the whole foot
timeFrame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.
measure: Change in vertical ground reaction force (vGRF) of the midfoot
timeFrame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.
measure: Change in vertical ground reaction force (vGRF) of the forefoot
timeFrame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.
measure: Change in average loading rate
timeFrame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.
measure: Change in instantaneous loading rate
timeFrame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.
measure: Change in knee sagittal plane kinematics
timeFrame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.
measure: Change in hip sagittal plane kinematics
timeFrame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.
measure: Change in ankle sagittal plane kinematics
timeFrame: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.
measure: Change in steps per day
timeFrame: This outcome change will be measured everyday for 8 weeks
measure: Change in activity level per day
timeFrame: This outcome change will be measured everyday for 8 weeks
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Jennifer Xu, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia
name: Susan Saliba, PhD
role: PRINCIPAL_INVESTIGATOR
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