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CompletedNCT06401954Updated Jun 30, 2026

High-Intensity Focused Electromagnetic Therapy Combined With Foot Core Training for Pronated Foot

An interventional study of High-intensity focused electromagnetic therapy and Foot core training in Flexible Flatfoot, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study summary

The objective of this trial is to assess the effects of high-intensity focused electromagnetic therapy combined with foot core training targeting the intrinsic foot muscles on plantar load, static foot posture, intrinsic foot muscle morphology and intrinsic foot muscle activation in individuals with pronated foot.

The main questions it aims to answer are:

Question 1: To compare changes in plantar load following interventions of high-intensity focused electromagnetic therapy combined with foot core training, high-intensity focused electromagnetic therapy alone, and sham high-intensity focused electromagnetic therapy combined with foot core training.

Question 2: To compare changes in static foot posture, intrinsic foot muscle morphology, and intrinsic foot muscle activation following interventions of high-intensity focused electromagnetic therapy combined with foot core training, high-intensity focused electromagnetic therapy alone, and sham high-intensity focused electromagnetic therapy combined with foot core training.

Question 3: To assess the effects of each intervention on plantar load, static foot posture, intrinsic foot muscle morphology, and intrinsic foot muscle activation in individuals with pronated foot.

Participants will undergo stimulation of their intrinsic foot muscles through high-intensity focused electromagnetic therapy, and they will also be required to isometrically contract their intrinsic foot muscles during the designated exercise program. Researchers will assess the effects of high-intensity focused electromagnetic therapy combined with foot core training by evaluating plantar load during walking, static foot posture, intrinsic foot muscle morphology and intrinsic foot muscle activation during walking.

Read the detailed description

The objective of this trial is to assess the effects of high-intensity focused electromagnetic therapy combined with foot core training targeting the intrinsic foot muscles on plantar load, static foot posture, intrinsic foot muscle morphology and intrinsic foot muscle activation in individuals with pronated foot.

The main questions it aims to answer are:

Question 1: To compare changes in plantar load following interventions of high-intensity focused electromagnetic therapy combined with foot core training, high-intensity focused electromagnetic therapy alone, and sham high-intensity focused electromagnetic therapy combined with foot core training.

Question 2: To compare changes in static foot posture, intrinsic foot muscle morphology, and intrinsic foot muscle activation following interventions of high-intensity focused electromagnetic therapy combined with foot core training, high-intensity focused electromagnetic therapy alone, and sham high-intensity focused electromagnetic therapy combined with foot core training.

Question 3: To assess the effects of each intervention on plantar load, static foot posture, intrinsic foot muscle morphology, and intrinsic foot muscle activation in individuals with pronated foot.

Eligible participants will be randomly assigned to one of three groups: the high-intensity focused electromagnetic therapy combined with foot core training group, the high-intensity focused electromagnetic therapy group, or the sham high-intensity focused electromagnetic therapy combined with foot core training group.

High-intensity focused electromagnetic therapy sessions will last for 20 minutes each, while the foot core training program will comprise 4 exercises, with 10 repetitions per set and 3 sets per session for each exercise. Participants will undergo these interventions twice a week over a 6-week period.

Plantar load and electromyographic signals of the abductor hallucis muscle during gait, ultrasonography for morphological analysis of the intrinsic foot muscles, and static foot posture will be evaluated at baseline and 6 weeks following the intervention.

02

Conditions studied

  • Flexible Flatfoot

Browse trials for

Keywords

  • pronated foot
  • foot core system
  • dynamic foot function
  • high-intensity focused electromagnetic therapy
  • foot core training
03

In context

Flatfoot

173 studies on the registry are indexed under Flatfoot; 44 are open to participants now.

This study's enrollment of 30 is below the median of 40 across 122 interventional studies indexed under Flatfoot.

Browse Flatfoot studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 20 years old
  • Navicular drop test ≥ 10 mm
  • Foot Posture Index ≥ 6
  • Foot and ankle range of motion within normal limits

Exclusion criteria

Exclusion Criteria:

  • Rigid flatfoot
  • Any congenital deformity of lower extremity
  • Leg length discrepancy > 10 mm
  • Lower extremity injuries or surgeries in recent 6 months
  • Neurological deficits
  • of high-intensity focused electromagnetic therapy: pregnancy, unhealed wound, implanted electronic devices or other metal implants
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    HIFEM with foot core training

    High-intensity focused electromagnetic therapy is used to stimulate intrinsic foot muscles, and foot core training is performed with intrinsic foot muscle isometric contraction exercise.

    Device: High-intensity focused electromagnetic therapy · Behavioral: Foot core training

  • Active comparator
    HIFEM

    High-intensity focused electromagnetic therapy is used to stimulate intrinsic foot muscles

    Behavioral: Foot core training

  • Sham comparator
    Sham HIFEM with foot core training

    Sham high-intensity focused electromagnetic therapy is applied on intrinsic foot muscles, and foot core training is performed with intrinsic foot muscle isometric contraction exercise.

    Behavioral: Foot core training · Device: Sham high-intensity focused electromagnetic therapy

Interventions

  • DeviceHigh-intensity focused electromagnetic therapy

    High-intensity focused electromagnetic therapy is applied to intrinsic foot muscles, the intensity is set to stimulate muscle contraction. 20 minutes of intervention, twice a week, and a total of 6 weeks

  • BehavioralFoot core training

    Foot core training will consist of 4 exercises with 10 repetitions per set and 3 sets per session for each exercise. Twice a week for a total of six weeks.

  • DeviceSham high-intensity focused electromagnetic therapy

    Sham high-intensity focused electromagnetic therapy is applied to intrinsic foot muscles, the intensity is unable to stimulate muscle contraction. 20 minutes of intervention, twice a week, and a total of 6 weeks

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What researchers measure

Primary outcomes

  1. Change from baseline in plantar load at week 6

    Plantar load is measured by in-shoe pressure measurement system, and the data is collected during walking.

    Time frame: baseline, week 6

Secondary outcomes

  1. Change from baseline in static foot posture at week 6

    Static foot posture is measured by navicular drop test and Foot Posture Index

    Time frame: baseline, week 6

  2. Change from baseline in intrinsic foot muscle morphology at week 6

    Intrinsic foot muscle morphology is measured by ultrasonography, include measurements of thickness of abductor hallucis, flexor hallucis brevis and flexor digitorum brevis, and cross-sectional area of abductor hallucis

    Time frame: baseline, week 6

  3. Change from baseline in intrinsic foot muscle activation at week 6

    Intrinsic foot muscle activation is measured by electromyography, and data is collected during walking

    Time frame: baseline, week 6

07

Study locations

1 site
  • National Taiwan University Hospital
    Taipei, Taiwan
08

References and documents

Publications

  • Redmond AC, Crane YZ, Menz HB. Normative values for the Foot Posture Index. J Foot Ankle Res. 2008 Jul 31;1(1):6. doi: 10.1186/1757-1146-1-6. PubMed 18822155 ↗
  • Toullec E. Adult flatfoot. Orthop Traumatol Surg Res. 2015 Feb;101(1 Suppl):S11-7. doi: 10.1016/j.otsr.2014.07.030. Epub 2015 Jan 13. PubMed 25595429 ↗
  • Neal BS, Griffiths IB, Dowling GJ, Murley GS, Munteanu SE, Franettovich Smith MM, Collins NJ, Barton CJ. Foot posture as a risk factor for lower limb overuse injury: a systematic review and meta-analysis. J Foot Ankle Res. 2014 Dec 19;7(1):55. doi: 10.1186/s13047-014-0055-4. eCollection 2014. PubMed 25558288 ↗
  • Claus D, Waddy HM, Harding AE, Murray NM, Thomas PK. Hereditary motor and sensory neuropathies and hereditary spastic paraplegia: a magnetic stimulation study. Ann Neurol. 1990 Jul;28(1):43-9. doi: 10.1002/ana.410280109. PubMed 2375632 ↗
  • Razeghi M, Batt ME. Foot type classification: a critical review of current methods. Gait Posture. 2002 Jun;15(3):282-91. doi: 10.1016/s0966-6362(01)00151-5. PubMed 11983503 ↗
  • Buldt AK, Allan JJ, Landorf KB, Menz HB. The relationship between foot posture and plantar pressure during walking in adults: A systematic review. Gait Posture. 2018 May;62:56-67. doi: 10.1016/j.gaitpost.2018.02.026. Epub 2018 Feb 23. PubMed 29524798 ↗
  • Razak AH, Zayegh A, Begg RK, Wahab Y. Foot plantar pressure measurement system: a review. Sensors (Basel). 2012;12(7):9884-912. doi: 10.3390/s120709884. Epub 2012 Jul 23. PubMed 23012576 ↗
  • Cavanagh PR, Morag E, Boulton AJ, Young MJ, Deffner KT, Pammer SE. The relationship of static foot structure to dynamic foot function. J Biomech. 1997 Mar;30(3):243-50. doi: 10.1016/s0021-9290(96)00136-4. PubMed 9119823 ↗
  • Okamura K, Fukuda K, Oki S, Ono T, Tanaka S, Kanai S. Effects of plantar intrinsic foot muscle strengthening exercise on static and dynamic foot kinematics: A pilot randomized controlled single-blind trial in individuals with pes planus. Gait Posture. 2020 Jan;75:40-45. doi: 10.1016/j.gaitpost.2019.09.030. Epub 2019 Sep 29. PubMed 31590069 ↗
  • McKeon PO, Hertel J, Bramble D, Davis I. The foot core system: a new paradigm for understanding intrinsic foot muscle function. Br J Sports Med. 2015 Mar;49(5):290. doi: 10.1136/bjsports-2013-092690. Epub 2014 Mar 21. PubMed 24659509 ↗
  • Kelly LA, Cresswell AG, Racinais S, Whiteley R, Lichtwark G. Intrinsic foot muscles have the capacity to control deformation of the longitudinal arch. J R Soc Interface. 2014 Jan 29;11(93):20131188. doi: 10.1098/rsif.2013.1188. Print 2014 Apr 6. PubMed 24478287 ↗
  • Okamura K, Kanai S, Hasegawa M, Otsuka A, Oki S. The effect of additional activation of the plantar intrinsic foot muscles on foot dynamics during gait. Foot (Edinb). 2018 Mar;34:1-5. doi: 10.1016/j.foot.2017.08.002. Epub 2017 Aug 18. PubMed 29175714 ↗
  • Zhang X, Pauel R, Deschamps K, Jonkers I, Vanwanseele B. Differences in foot muscle morphology and foot kinematics between symptomatic and asymptomatic pronated feet. Scand J Med Sci Sports. 2019 Nov;29(11):1766-1773. doi: 10.1111/sms.13512. Epub 2019 Jul 26. PubMed 31278774 ↗
  • McKeon PO, Fourchet F. Freeing the foot: integrating the foot core system into rehabilitation for lower extremity injuries. Clin Sports Med. 2015 Apr;34(2):347-61. doi: 10.1016/j.csm.2014.12.002. Epub 2015 Jan 24. PubMed 25818718 ↗
  • Brijwasi T, Borkar P. A comprehensive exercise program improves foot alignment in people with flexible flat foot: a randomised trial. J Physiother. 2023 Jan;69(1):42-46. doi: 10.1016/j.jphys.2022.11.011. Epub 2022 Dec 14. PubMed 36526555 ↗
  • Huang C, Chen LY, Liao YH, Masodsai K, Lin YY. Effects of the Short-Foot Exercise on Foot Alignment and Muscle Hypertrophy in Flatfoot Individuals: A Meta-Analysis. Int J Environ Res Public Health. 2022 Sep 22;19(19):11994. doi: 10.3390/ijerph191911994. PubMed 36231295 ↗
  • Hara S, Kitano M, Kudo S. The effects of short foot exercises to treat flat foot deformity: A systematic review. J Back Musculoskelet Rehabil. 2023;36(1):21-33. doi: 10.3233/BMR-210374. PubMed 35871320 ↗
  • Utsahachant N, Sakulsriprasert P, Sinsurin K, Jensen MP, Sungkue S. Effects of short foot exercise combined with lower extremity training on dynamic foot function in individuals with flexible flatfoot: A randomized controlled trial. Gait Posture. 2023 Jul;104:109-115. doi: 10.1016/j.gaitpost.2023.06.013. Epub 2023 Jun 22. PubMed 37379736 ↗
  • Duncan D, Dinev I. Noninvasive Induction of Muscle Fiber Hypertrophy and Hyperplasia: Effects of High-Intensity Focused Electromagnetic Field Evaluated in an In-Vivo Porcine Model: A Pilot Study. Aesthet Surg J. 2020 Apr 14;40(5):568-574. doi: 10.1093/asj/sjz244. PubMed 31665217 ↗
  • Jacob C, Kinney B, Busso M, Chilukuri S, McCoy JD, Bailey C, Denkova R. High Intensity Focused Electro-Magnetic Technology (HIFEM) for Non-Invasive Buttock Lifting and Toning of Gluteal Muscles: A Multi-Center Efficacy and Safety Study. J Drugs Dermatol. 2018 Nov 1;17(11):1229-1232. PubMed 30500146 ↗
  • Silantyeva E, Zarkovic D, Astafeva E, Soldatskaia R, Orazov M, Belkovskaya M, Kurtser M; Academician of the Russian Academy of Sciences. A Comparative Study on the Effects of High-Intensity Focused Electromagnetic Technology and Electrostimulation for the Treatment of Pelvic Floor Muscles and Urinary Incontinence in Parous Women: Analysis of Posttreatment Data. Female Pelvic Med Reconstr Surg. 2021 Apr 1;27(4):269-273. doi: 10.1097/SPV.0000000000000807. PubMed 31860567 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06401954
Responsible party
Sponsor
First posted
May 7, 2024
Start date
May 15, 2024
Primary completion
Aug 30, 2024
Completion
Dec 31, 2024
Last update
Jun 30, 2026

Study contacts

Yueh-Hsia Chen, PhD
principal investigator · National Taiwan University, School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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