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

NCT06106958 | Completed

• 1 other identifier: HSR230045
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (14)

• Change in kinesiophobia

  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

  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

  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

  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

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

Study Arms (2)

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.

Behavioral: Home Exercise Program; Behavioral: Minimalist Shoes

Home Exercise Program (Control)

ACTIVE COMPARATOR

The intervention group will receive a home exercise program.

Behavioral: Home Exercise Program

Interventions

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.

Foot Rehabilitation And Minimalist Shoes (FRAMES); Home Exercise Program (Control)

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

Foot Rehabilitation And Minimalist Shoes (FRAMES)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (14)

• 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.

  PMID: 28461226 BACKGROUND

• Allen 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.

  PMID: 12968860 BACKGROUND

• Cheung 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.

  PMID: 26655866 BACKGROUND

• Chang 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.

  PMID: 24992816 BACKGROUND

• Wearing 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.

  PMID: 16796396 BACKGROUND

• Jaffri 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.

  PMID: 35724360 BACKGROUND

• Newsham K. Exploring Workload Associated With Learning Foot Core Exercises. International Journal of Athletic Therapy and Training. 2022;27(3):120-128.

  BACKGROUND

• 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.

  PMID: 30113521 BACKGROUND

• Warne 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.

  PMID: 28916956 BACKGROUND

• Ribeiro 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.

  PMID: 36363506 BACKGROUND

• Yeasmin 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

• 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.

  PMID: 25145882 BACKGROUND

• Campitelli 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.

  PMID: 27762613 BACKGROUND

• Kamonseki 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.

  PMID: 26654252 BACKGROUND

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Jennifer Xu, MS

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Susan Saliba, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator assessing laboratory-based outcome measures will be blinded to group allocation and will not be the member of the study team communicating with participants about their intervention protocols.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Student

Model Details: There will be two groups: 1. Performing foot rehabilitation exercises and wearing minimalist shoes (intervention group) 2. Only performing foot rehabilitation exercises (control group)

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 30, 2023
• Study Start: February 14, 2024
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)