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Flexible FlatfootNCT06401954

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

A study testing High-intensity focused electromagnetic therapy and Foot core training in people with Flexible Flatfoot, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Flexible Flatfoot
What is being tested?
High-intensity focused electromagnetic therapy and Foot core training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteTaiwan
Study dates
15 May 2024to 31 Dec 2024
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 20 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • National Taiwan University Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: Effects of High-Intensity Focused Electromagnetic Therapy Combined With Foot Core Training on Dynamic Foot Function in Individuals With Pronated Foot

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:

Read more

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.

Being tested
High-intensity focused electromagnetic therapy, Foot core training, Sham high-intensity focused electromagnetic therapy
Keywords
pronated foot, foot core system, dynamic foot function, high-intensity focused electromagnetic therapy, foot core training
Medical subject headings
Flatfoot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-intensity focused electromagnetic therapyDevice

    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

  • Foot core trainingBehavioural

    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.

  • Sham high-intensity focused electromagnetic therapyDevice

    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

Study groups in NCT06401954
Study groupRoleWhat they receive
HIFEM with foot core trainingExperimentalHigh-intensity focused electromagnetic therapy is used to stimulate intrinsic foot muscles, and foot core training is performed with intrinsic foot muscle isometric contraction exercise.
Receives: Device: High-intensity focused electromagnetic therapy; Behavioral: Foot core training
HIFEMActive comparatorHigh-intensity focused electromagnetic therapy is used to stimulate intrinsic foot muscles
Receives: Behavioral: Foot core training
Sham HIFEM with foot core trainingSham comparatorSham high-intensity focused electromagnetic therapy is applied on intrinsic foot muscles, and foot core training is performed with intrinsic foot muscle isometric contraction exercise.
Receives: Behavioral: Foot core training; Device: Sham high-intensity focused electromagnetic therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline, week 6

Secondary outcomes (3)
  1. Change from baseline in static foot posture at week 6

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

    Measured: 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

    Measured: 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

    Measured: baseline, week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2024
  2. Study start15 May 2024
  3. Primary completion30 Aug 2024
  4. Study completion31 Dec 2024

Resources

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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06401954
Sponsor's protocol ID
202402010RINA
Status last verified
Jun 2026
First submitted
2 May 2024
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing High-intensity focused electromagnetic therapy and Foot core training in people with Flexible Flatfoot, run by National Taiwan University Hospital at 1 site in Taiwan.

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 4 inclusion and 6 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 30 Jun 2026. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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 from baseline in plantar load at week 6 (time frame: baseline, week 6). 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 NCT06401954, which also lists 21 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 30 Jun 2026; AzTrials last refreshed its copy on 2 Nov 2026.

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