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

Plantar Fascitis Clinical Trial

— FRAMES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06106958
• Other study ID #: HSR230045
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2024
• Est. completion date: May 20, 2025

Study information

• Verified date: June 2024
• Source: University of Virginia
• Contact: Jennifer Xu, MS
• Phone: 2152643222
• Email: tnd9vf[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: May 20, 2025
• Est. primary completion date: April 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis of Both Feet
• Plantar Fasciitis, Chronic
• Plantar Fasciopathy
• Plantar Fascitis

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Change in steps per day	Steps per day measured on a Fitbit	This outcome change will be measured everyday for 8 weeks
Secondary	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