Peripheral Magnetic Stimulation of Foot Muscles: Effects on Medial Longitudinal Arch Height and Foot Muscle Strength in Adults With Flat Feet
NCT ID: NCT07237321
Last Updated: 2025-11-25
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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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-12-15
2027-12-31
Brief Summary
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Assessments will be performed at baseline, after 6 weeks, and after 12 weeks of intervention. The primary outcome will be the change in the height of the MLA, evaluated using dynamic navicular drop assessment during gait. Secondary outcomes will include changes in the isometric inversion torque of the foot invertors and morphological adaptations of the tibialis posterior muscle assessed by ultrasound imaging.
This study seeks to determine whether rPMS can improve the height of the MLA, foot invertor muscle strength and structural stability in adults with flat feet. The findings may contribute to developing new, non-invasive therapeutic approaches for improving foot function and preventing musculoskeletal imbalances related to flat foot deformity.
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Detailed Description
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The foot muscles are classified as extrinsic (originating outside the foot) and intrinsic (originating and inserting within the foot). Extrinsic muscles, primarily stabilize the ankle joint and control larger movements, whereas intrinsic muscles store and release elastic energy within the foot, contributing to arch support and movement efficiency.
A lowered height or collapsed arch of the foot, known as flat foot (pes planus), is characterized by arch flattening during weight-bearing and affects approximately 13-27% of the adult population. This deformity alters force distribution and shock absorption, increasing mechanical load on the joints and muscles of the lower kinetic chain. Consequently, flat feet are often associated with foot pain, tendinopathies, and different musculoskeletal disorders in the knees, hips, and lumbar spine.
One of the main causes of flat foot deformity is dysfunction of the tibialis posterior (TP) tendon. This dysfunction leads to reduced muscle strength, decreased neuromuscular activation of the foot invertors and plantar flexors, and subsequent lowering of the navicular bone, resulting in a reduced MLA height. Strengthening the m. TP not only maintains arch position but also improves gait efficiency by reducing compensatory activation of other muscles. This muscle is considered as the strongest foot invertor and has the largest moment arm along the subtalar axis.
Recent research highlights that strengthening foot invertor muscles, particularly m. TP, can effectively increase height of the MLA. Conventional interventions include specific exercise programs and proprioceptive neuromuscular facilitation techniques. However, neuromuscular electrical stimulation used in previous studies did not showed significant increases in MLA height, partly due to pain and discomfort during deep muscle stimulation.
Repetitive peripheral magnetic stimulation (rPMS) has emerged as a promising non-invasively alternative, capable of stimulating deep neuromuscular structures. Several studies have shown that high-frequency rPMS can induce muscle activation, transient swelling, and potential hypertrophy indicators. Nevertheless, there is limited evidence on the long-term (multi-week) effects of rPMS on deep muscles such as the m. TP.
Aim of this research is to implement a 12-week rPMS protocol targeting both extrinsic and intrinsic foot invertor muscles, and to examine whether rPMS induces changes in the height of the MLA. Additionally, the study aims to determine whether 12-week rPMS protocol contributed to increased strength and cross-sectional area of the m. TP.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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rPMS Stimulation Group
Subjects in this group will receive repetitive peripheral magnetic stimulation (rPMS) of the foot invertor muscles three times per week for 12 weeks. Stimulation will be applied to the upper third of the anteromedial side of the shin. Intrinsic foot muscles will be simultaneously stimulated using a foot stimulator, with the nondominant foot placed on the stimulation platform. Participants in the experimental group will complete ultrasound imaging, navicular drop assessment, clinical evaluation of the plantar arch index, and isometric strength testing of the foot invertor muscles at three time points: before the intervention (baseline), after 6 weeks, and after 12-week stimulation period.
Repetitive Peripheral Magnetic Stimulation (rPMS)
Repetitive peripheral magnetic stimulation (rPMS) will be applied to the foot invertor muscles three times per week for 12 weeks. Stimulation will target the upper third of the anteromedial side of the shin, near the tibia, using an oval magnetic coil. To ensure correct coil placement, visible muscle contraction and ankle inversion will be monitored. Intrinsic foot muscles will be simultaneously stimulated using a foot stimulator, with the nondominant foot positioned on the stimulation platform. Participants will perform isometric inversion contractions during rPMS to enhance neuromuscular activation and short-foot exercises to engage local foot stabilizers.
Control Group (no stimulation)
Subjects in control group will not receive any stimulation but will undergo the same measurement procedures as the experimental group, including ultrasound imaging, navicular drop assessment, clinical evaluation of the plantar arch index, and isometric strength testing of the foot invertor muscles before and after the 6- and 12-week period.
No interventions assigned to this group
Interventions
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Repetitive Peripheral Magnetic Stimulation (rPMS)
Repetitive peripheral magnetic stimulation (rPMS) will be applied to the foot invertor muscles three times per week for 12 weeks. Stimulation will target the upper third of the anteromedial side of the shin, near the tibia, using an oval magnetic coil. To ensure correct coil placement, visible muscle contraction and ankle inversion will be monitored. Intrinsic foot muscles will be simultaneously stimulated using a foot stimulator, with the nondominant foot positioned on the stimulation platform. Participants will perform isometric inversion contractions during rPMS to enhance neuromuscular activation and short-foot exercises to engage local foot stabilizers.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* functionally flat feet of participants.
Exclusion Criteria
* diabetes,
* vascular disorders of the lower limbs,
* open wounds or skin lesions on the lower leg or foot,
* participants with metal implants near the stimulation site,
* cardiac pacemaker,
* other orthopedic or neurological conditions that could affect the study results or pose a health risk to the participants.
18 Years
50 Years
ALL
No
Sponsors
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University of Ljubljana, Faculty of Medicine
OTHER
University of Ljubljana
OTHER
Responsible Party
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Ales Dolenec
Associate Professor, Faculty of Sport, University of Ljubljana
Principal Investigators
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Rok Bavdek, PhD
Role: PRINCIPAL_INVESTIGATOR
Nejc Umek, MD PhD
Role: STUDY_DIRECTOR
Institute of Anatomy, Faculty of Medicine, University of Ljubljana
Jure Jelenc, PhD
Role: STUDY_DIRECTOR
Iskra Medical, d.o.o.
Locations
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Faculty of Sport, University of Ljubljana
Ljubljana, Ljubljana, Slovenia
Countries
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Central Contacts
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References
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Zschorlich V, Yamaguchi T, Schneider C. Editorial: The use of repetitive peripheral magnetic stimulation (rPMS) in neurological disorders and neurorehabilitation. Front Neurol. 2023 Nov 20;14:1324882. doi: 10.3389/fneur.2023.1324882. eCollection 2023. No abstract available.
Hirono T, Ikezoe T, Taniguchi M, Nojiri S, Tanaka H, Ichihashi N. Acute effects of repetitive peripheral magnetic stimulation following low-intensity isometric exercise on muscle swelling for selective muscle in healthy young men. Electromagn Biol Med. 2021 Jul 3;40(3):420-427. doi: 10.1080/15368378.2021.1907402. Epub 2021 Mar 25.
Masse-Alarie H, Flamand VH, Moffet H, Schneider C. Peripheral neurostimulation and specific motor training of deep abdominal muscles improve posturomotor control in chronic low back pain. Clin J Pain. 2013 Sep;29(9):814-23. doi: 10.1097/AJP.0b013e318276a058.
Neugebauer R. [Surgical treatment of colon cancer. 4. Preoperative preparation of the colon]. Aktuelle Probl Chir Orthop. 1979;(10):38-40. No abstract available. German.
Baek J, Park N, Lee B, Jee S, Yang S, Kang S. Effects of Repetitive Peripheral Magnetic Stimulation Over Vastus Lateralis in Patients After Hip Replacement Surgery. Ann Rehabil Med. 2018 Feb;42(1):67-75. doi: 10.5535/arm.2018.42.1.67. Epub 2018 Feb 28.
Yang SS, Jee S, Hwang SL, Sohn MK. Strengthening of Quadriceps by Neuromuscular Magnetic Stimulation in Healthy Subjects. PM R. 2017 Aug;9(8):767-773. doi: 10.1016/j.pmrj.2016.12.002. Epub 2017 Jan 8.
Aenumulapalli A, Kulkarni MM, Gandotra AR. Prevalence of Flexible Flat Foot in Adults: A Cross-sectional Study. J Clin Diagn Res. 2017 Jun;11(6):AC17-AC20. doi: 10.7860/JCDR/2017/26566.10059. Epub 2017 Jun 1.
Kelly LA, Farris DJ, Cresswell AG, Lichtwark GA. Intrinsic foot muscles contribute to elastic energy storage and return in the human foot. J Appl Physiol (1985). 2019 Jan 1;126(1):231-238. doi: 10.1152/japplphysiol.00736.2018. Epub 2018 Nov 21.
Beaulieu LD, Schneider C. Repetitive peripheral magnetic stimulation to reduce pain or improve sensorimotor impairments: A literature review on parameters of application and afferents recruitment. Neurophysiol Clin. 2015 Sep;45(3):223-37. doi: 10.1016/j.neucli.2015.08.002. Epub 2015 Sep 9.
Ross MH, Smith MD, Mellor R, Vicenzino B. Exercise for posterior tibial tendon dysfunction: a systematic review of randomised clinical trials and clinical guidelines. BMJ Open Sport Exerc Med. 2018 Sep 19;4(1):e000430. doi: 10.1136/bmjsem-2018-000430. eCollection 2018.
Kohls-Gatzoulis J, Angel JC, Singh D, Haddad F, Livingstone J, Berry G. Tibialis posterior dysfunction: a common and treatable cause of adult acquired flatfoot. BMJ. 2004 Dec 4;329(7478):1328-33. doi: 10.1136/bmj.329.7478.1328. No abstract available.
Jia Y, Sai X, Zhang E. Comparing the efficacy of exercise therapy on adult flexible flatfoot individuals through a network meta-analysis of randomized controlled trials. Sci Rep. 2024 Sep 11;14(1):21186. doi: 10.1038/s41598-024-72149-w.
Hegazy F, Aboelnasr E, Abuzaid M, Kim IJ, Salem Y. Comparing Validity and Diagnostic Accuracy of Clarke's Angle and Foot Posture Index-6 to Determine Flexible Flatfoot in Adolescents: A Cross-Sectional Investigation. J Multidiscip Healthc. 2021 Sep 27;14:2705-2717. doi: 10.2147/JMDH.S317439. eCollection 2021.
Michaudet C, Edenfield KM, Nicolette GW, Carek PJ. Foot and Ankle Conditions: Pes Planus. FP Essent. 2018 Feb;465:18-23.
Dowling GJ, Murley GS, Munteanu SE, Smith MM, Neal BS, Griffiths IB, Barton CJ, Collins NJ. Dynamic foot function as a risk factor for lower limb overuse injury: a systematic review. J Foot Ankle Res. 2014 Dec 19;7(1):53. doi: 10.1186/s13047-014-0053-6. eCollection 2014.
de Souza TMM, de Oliveira Coutinho VG, Tessutti VD, de Oliveira NRC, Yi LC. Effects of intrinsic foot muscle strengthening on the medial longitudinal arch mobility and function: A systematic review. J Bodyw Mov Ther. 2023 Oct;36:89-99. doi: 10.1016/j.jbmt.2023.05.010. Epub 2023 Jun 10.
Johnson AW, Bruening DA, Violette VA, Perkins KV, Thompson CL, Ridge ST. Ultrasound Imaging Is Reliable for Tibialis Posterior Size Measurements. J Ultrasound Med. 2020 Dec;39(12):2305-2312. doi: 10.1002/jum.15340. Epub 2020 May 15.
Other Identifiers
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P5-0124, P3-0043
Identifier Type: OTHER
Identifier Source: secondary_id
rPMS, 0124-0043
Identifier Type: -
Identifier Source: org_study_id
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