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

Flexible Flatfoot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06401954
• Other study ID #: 202402010RINA
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: May 15, 2025

Study information

• Verified date: April 2024
• Source: National Taiwan University Hospital
• Contact: Yueh-Hsia Chen, PhD
• Phone: +886-3366-8133
• Email: yuehhsiachen[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 15, 2025
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Flatfoot
• Flexible Flatfoot

Intervention

Device:
• 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

Behavioral:
• 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.

Device:
• 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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (21)

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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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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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. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, week 6
Secondary	Change from baseline in static foot posture at week 6	Static foot posture is measured by navicular drop test and Foot Posture Index	baseline, week 6
Secondary	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	baseline, week 6
Secondary	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	baseline, week 6