Plantar FascitisFRAMESNCT06106958
Effects of Foot Rehabilitation And Minimalist Shoes on Pain, Strength, and Function in Adults With Plantar Fasciopathy
A study testing Home Exercise Program and Minimalist Shoes in people with Plantar Fascitis and Plantar Fasciopathy, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Plantar Fascitis, Plantar Fasciopathy, Plantar Fasciitis of Both Feet
- What is being tested?
- Home Exercise Program and Minimalist Shoes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2024to 20 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
Official title: The Effects of Foot Rehabilitation And Minimalist Shoes (FRAMES) 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?
Read more
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
Read the 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.
- Conditions
- Plantar Fascitis, Plantar Fasciopathy, Plantar Fasciitis of Both Feet, Plantar Fasciitis of Right Foot, Plantar Fasciitis of Left Foot, Plantar Fasciitis, Chronic
- Being tested
- Home Exercise Program, Minimalist Shoes
- Keywords
- plantar fasciitis, intrinsic foot muscles, minimalist shoes
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Exercise ProgramBehavioural
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 ShoesBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Foot Rehabilitation And Minimalist Shoes (FRAMES) | Experimental | 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. Receives: Behavioral: Home Exercise Program; Behavioral: Minimalist Shoes |
| Home Exercise Program (Control) | Active comparator | The intervention group will receive a home exercise program. Receives: Behavioral: Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: This outcome change will be measured from baseline, to the end of the intervention (8 weeks) for both groups.
Secondary outcomes (14)
Change in kinesiophobia
Tampa Scale of Kinesiophobia (TSK-11) outcome scores
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: This outcome change will be measured everyday for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start14 Feb 2024
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jen Xu, University of Virginia
- Investigators
- Jennifer Xu, MS, Principal investigator, University of VirginiaSusan Saliba, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106958
- Sponsor's protocol ID
- HSR230045
- Acronym
- FRAMES
- Status last verified
- Jul 2025
- First submitted
- 19 Oct 2023
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barnes A, Sullivan J, Pappas E, Adams R, Burns J. Clinical and Functional Characteristics of People With Chronic and Recent-Onset Plantar Heel Pain. PM R. 2017 Nov;9(11):1128-1134. doi: 10.1016/j.pmrj.2017.04.009. Epub 2017 Apr 28.
PubMed 28461226Allen RH, Gross MT. Toe flexors strength and passive extension range of motion of the first metatarsophalangeal joint in individuals with plantar fasciitis. J Orthop Sports Phys Ther. 2003 Aug;33(8):468-78. doi: 10.2519/jospt.2003.33.8.468.
PubMed 12968860Cheung RT, Sze LK, Mok NW, Ng GY. Intrinsic foot muscle volume in experienced runners with and without chronic plantar fasciitis. J Sci Med Sport. 2016 Sep;19(9):713-5. doi: 10.1016/j.jsams.2015.11.004. Epub 2015 Nov 22.
PubMed 26655866Chang R, Rodrigues PA, Van Emmerik RE, Hamill J. Multi-segment foot kinematics and ground reaction forces during gait of individuals with plantar fasciitis. J Biomech. 2014 Aug 22;47(11):2571-7. doi: 10.1016/j.jbiomech.2014.06.003. Epub 2014 Jun 11.
PubMed 24992816Wearing SC, Smeathers JE, Urry SR, Hennig EM, Hills AP. The pathomechanics of plantar fasciitis. Sports Med. 2006;36(7):585-611. doi: 10.2165/00007256-200636070-00004.
PubMed 16796396Jaffri AH, Koldenhoven R, Saliba S, Hertel J. Evidence for Intrinsic Foot Muscle Training in Improving Foot Function: A Systematic Review and Meta-Analysis. J Athl Train. 2023 Nov 1;58(11-12):941-951. doi: 10.4085/1062-6050-0162.22.
PubMed 35724360Newsham K. Exploring Workload Associated With Learning Foot Core Exercises. International Journal of Athletic Therapy and Training. 2022;27(3):120-128.
Ridge ST, Olsen MT, Bruening DA, Jurgensmeier K, Griffin D, Davis IS, Johnson AW. Walking in Minimalist Shoes Is Effective for Strengthening Foot Muscles. Med Sci Sports Exerc. 2019 Jan;51(1):104-113. doi: 10.1249/MSS.0000000000001751.
PubMed 30113521Warne JP, Gruber AH. Transitioning to Minimal Footwear: a Systematic Review of Methods and Future Clinical Recommendations. Sports Med Open. 2017 Sep 15;3(1):33. doi: 10.1186/s40798-017-0096-x.
PubMed 28916956Ribeiro AP, Joao SMA. The Effect of Short and Long-Term Therapeutic Treatment with Insoles and Shoes on Pain, Function, and Plantar Load Parameters of Women with Plantar Fasciitis: A Randomized Controlled Trial. Medicina (Kaunas). 2022 Oct 28;58(11):1546. doi: 10.3390/medicina58111546.
PubMed 36363506Yeasmin Lipa L, Kalita A, Dutta A. A Comparative Study To Find Out The Effectiveness Of Myofascial Release Technique Along With Stretching Versus Myofascial Release Technique In Patients With Plantar Fasciitis. Int J Life Sci Pharm Res. Published online January 31, 2022. doi:10.22376/ijpbs/lpr.2022.12.1.L183-193
Rathleff MS, Molgaard CM, Fredberg U, Kaalund S, Andersen KB, Jensen TT, Aaskov S, Olesen JL. High-load strength training improves outcome in patients with plantar fasciitis: A randomized controlled trial with 12-month follow-up. Scand J Med Sci Sports. 2015 Jun;25(3):e292-300. doi: 10.1111/sms.12313. Epub 2014 Aug 21.
PubMed 25145882Campitelli NA, Spencer SA, Bernhard K, Heard K, Kidon A. Effect of Vibram FiveFingers Minimalist Shoes on the Abductor Hallucis Muscle. J Am Podiatr Med Assoc. 2016 Sep 2;106(5):344-351. doi: 10.7547/14-084.
PubMed 27762613Kamonseki DH, Goncalves GA, Yi LC, Junior IL. Effect of stretching with and without muscle strengthening exercises for the foot and hip in patients with plantar fasciitis: A randomized controlled single-blind clinical trial. Man Ther. 2016 Jun;23:76-82. doi: 10.1016/j.math.2015.10.006. Epub 2015 Oct 30.
PubMed 26654252Xu J, Hertel J, Kuenze C, Jaffri AH, Saliba SA. The effects of performing therapeutic exercises and wearing minimalist shoes on intrinsic foot muscle function and single-leg balance in adults with plantar fasciopathy. Clin Biomech (Bristol). 2026 Jul;137:106869. doi: 10.1016/j.clinbiomech.2026.106869. Epub 2026 May 9.
PubMed 42155155
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Foot Rehabilitation And Minimalist Shoes (FRAMES) on Pain, Strength, and Function in Adults With Plantar Fasciopathy
- ClinicalTrials.gov ID
- NCT06106958
- Acronym / sponsor ID
- FRAMES / HSR230045
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Foot Rehabilitation And Minimalist Shoes (FRAMES) | Experimental | Behavioral: Home Exercise Program, Behavioral: Minimalist ShoesThe 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. |
| Home Exercise Program (Control) | Active comparator | Behavioral: Home Exercise ProgramThe intervention group will receive a home exercise program. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Exercise ProgramParticipants 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. | Behavioural | Foot Rehabilitation And Minimalist Shoes (FRAMES), Home Exercise Program (Control) |
| Minimalist ShoesParticipants 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 | Behavioural | Foot Rehabilitation And Minimalist Shoes (FRAMES) |
Primary outcome
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
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
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
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
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.
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
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.
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)
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.
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.
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
14 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Change in steps per day
Time frame: This outcome change will be measured everyday for 8 weeks
Change in activity level per day
Time frame: This outcome change will be measured everyday for 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Background: PubMed 28461226Barnes A, Sullivan J, Pappas E, Adams R, Burns J. Clinical and Functional Characteristics of People With Chronic and Recent-Onset Plantar Heel Pain. PM R. 2017 Nov;9(11):1128-1134. doi: 10.1016/j.pmrj.2017.04.009. Epub 2017 Apr 28.
- Background: PubMed 12968860Allen RH, Gross MT. Toe flexors strength and passive extension range of motion of the first metatarsophalangeal joint in individuals with plantar fasciitis. J Orthop Sports Phys Ther. 2003 Aug;33(8):468-78. doi: 10.2519/jospt.2003.33.8.468.
- Background: PubMed 26655866Cheung RT, Sze LK, Mok NW, Ng GY. Intrinsic foot muscle volume in experienced runners with and without chronic plantar fasciitis. J Sci Med Sport. 2016 Sep;19(9):713-5. doi: 10.1016/j.jsams.2015.11.004. Epub 2015 Nov 22.
- Background: PubMed 24992816Chang R, Rodrigues PA, Van Emmerik RE, Hamill J. Multi-segment foot kinematics and ground reaction forces during gait of individuals with plantar fasciitis. J Biomech. 2014 Aug 22;47(11):2571-7. doi: 10.1016/j.jbiomech.2014.06.003. Epub 2014 Jun 11.
- Background: PubMed 16796396Wearing SC, Smeathers JE, Urry SR, Hennig EM, Hills AP. The pathomechanics of plantar fasciitis. Sports Med. 2006;36(7):585-611. doi: 10.2165/00007256-200636070-00004.
- Background: PubMed 35724360Jaffri AH, Koldenhoven R, Saliba S, Hertel J. Evidence for Intrinsic Foot Muscle Training in Improving Foot Function: A Systematic Review and Meta-Analysis. J Athl Train. 2023 Nov 1;58(11-12):941-951. doi: 10.4085/1062-6050-0162.22.
- BackgroundNewsham K. Exploring Workload Associated With Learning Foot Core Exercises. International Journal of Athletic Therapy and Training. 2022;27(3):120-128.
- Background: PubMed 30113521Ridge ST, Olsen MT, Bruening DA, Jurgensmeier K, Griffin D, Davis IS, Johnson AW. Walking in Minimalist Shoes Is Effective for Strengthening Foot Muscles. Med Sci Sports Exerc. 2019 Jan;51(1):104-113. doi: 10.1249/MSS.0000000000001751.
- Background: PubMed 28916956Warne JP, Gruber AH. Transitioning to Minimal Footwear: a Systematic Review of Methods and Future Clinical Recommendations. Sports Med Open. 2017 Sep 15;3(1):33. doi: 10.1186/s40798-017-0096-x.
- Background: PubMed 36363506Ribeiro AP, Joao SMA. The Effect of Short and Long-Term Therapeutic Treatment with Insoles and Shoes on Pain, Function, and Plantar Load Parameters of Women with Plantar Fasciitis: A Randomized Controlled Trial. Medicina (Kaunas). 2022 Oct 28;58(11):1546. doi: 10.3390/medicina58111546.
- BackgroundYeasmin Lipa L, Kalita A, Dutta A. A Comparative Study To Find Out The Effectiveness Of Myofascial Release Technique Along With Stretching Versus Myofascial Release Technique In Patients With Plantar Fasciitis. Int J Life Sci Pharm Res. Published online January 31, 2022. doi:10.22376/ijpbs/lpr.2022.12.1.L183-193
- Background: PubMed 25145882Rathleff MS, Molgaard CM, Fredberg U, Kaalund S, Andersen KB, Jensen TT, Aaskov S, Olesen JL. High-load strength training improves outcome in patients with plantar fasciitis: A randomized controlled trial with 12-month follow-up. Scand J Med Sci Sports. 2015 Jun;25(3):e292-300. doi: 10.1111/sms.12313. Epub 2014 Aug 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Xu, MS principal investigator
University of Virginia
Susan Saliba, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Exercise Program and Minimalist Shoes in people with Plantar Fascitis and Plantar Fasciopathy, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06106958, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.