High-Intensity Focused Electromagnetic Therapy Combined With Foot Core Training for Pronated Foot
NCT ID: NCT06401954
Last Updated: 2025-03-18
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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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-05-15
2025-05-15
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
High-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
Foot 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.
HIFEM
High-intensity focused electromagnetic therapy is used to stimulate intrinsic foot muscles
Foot 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.
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.
Foot 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.
Sham 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
Interventions
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High-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
Foot 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.
Sham 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
Eligibility Criteria
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Inclusion Criteria
* Navicular drop test ≥ 10 mm
* Foot Posture Index ≥ 6
* Foot and ankle range of motion within normal limits
Exclusion Criteria
* 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
20 Years
65 Years
ALL
Yes
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Yueh-Hsia Chen, PhD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University, School of Medicine
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Yueh-Hsia Chen, PhD
Role: primary
References
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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.
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.
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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.
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.
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.
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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.
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.
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.
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.
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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.
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.
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.
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.
Other Identifiers
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202402010RINA
Identifier Type: -
Identifier Source: org_study_id
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