Effects of Foot Rehabilitation And Minimalist Shoes on Pain, Strength, and Function in Adults With Plantar Fasciopathy
NCT ID: NCT06106958
Last Updated: 2025-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2024-02-14
2025-01-20
Brief Summary
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* 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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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
1. Performing foot rehabilitation exercises and wearing minimalist shoes (intervention group)
2. Only performing foot rehabilitation exercises (control group)
TREATMENT
SINGLE
Study Groups
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Foot Rehabilitation And Minimalist Shoes (FRAMES)
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.
Home Exercise Program
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
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
Home Exercise Program (Control)
The intervention group will receive a home exercise program.
Home Exercise Program
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.
Interventions
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Home Exercise Program
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
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
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
55 Years
ALL
No
Sponsors
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University of Virginia
OTHER
Responsible Party
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Jen Xu
Doctoral Student
Principal Investigators
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Jennifer Xu, MS
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Susan Saliba, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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University of Virginia
Charlottesville, Virginia, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Newsham 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.
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.
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.
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
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.
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.
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.
Other Identifiers
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HSR230045
Identifier Type: -
Identifier Source: org_study_id
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