Peripheral Magnetic Stimulation of Foot Muscles: Effects on Medial Longitudinal Arch Height and Foot Muscle Strength in Adults With Flat Feet

NCT07237321 | Not Yet Recruiting

• 2 other identifiers: rPMS, 0124-0043P5-0124, P3-0043
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the effects of repetitive peripheral magnetic stimulation (rPMS) on foot invertor muscle strength, morphology, and the height of the medial longitudinal arch (MLA) in individuals with flat feet. The rPMS will be applied non-invasively to the extrinsic and intrinsic foot muscles three times per week for twelve weeks. The experimental group will receive rPMS targeting the invertor muscles of the foot, while the control group will not receive stimulation but will follow the same measurement schedule. 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.

Conditions

Pes Planus; Flatfoot; Posterior Tibial Tendon Dysfunction

Keywords

Medial Longitudinal Arch; Flatfoot; rPMS; foot invertors; tibialis posterior; repetitive peripheral magnetic stimulation; foot; posterior tibial tendon dysfunction; strength; ultrasound; muscle cross-sectional area

Outcome Measures

Primary Outcomes (1)

• Change in medial longitudinal arch height

  Measuring dynamic navicular drop assessment during the stance phase of gait.

  Baseline (Day 1), Week 6, Week 12

Secondary Outcomes (1)

• Change in isometric inversion torque of the stimulated foot

  Baseline (Day 1), Week 6, Week 12

Other Outcomes (1)

• Change in cross-sectional area of the tibialis posterior muscle

  Baseline (Day 1), Week 6, Week 12

Study Arms (2)

rPMS Stimulation Group

EXPERIMENTAL

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.

Device: Repetitive Peripheral Magnetic Stimulation (rPMS)

Control Group (no stimulation)

NO INTERVENTION

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.

Interventions

Repetitive Peripheral Magnetic Stimulation (rPMS) DEVICE

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.

Also known as: Peripheral Magnetic Stimulation, rPMS, FMS, Functional Magnetic Stimulation

rPMS Stimulation Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 50 years,
• functionally flat feet of participants.

You may not qualify if:

• Acute leg injuries,
• 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.

Sponsors & Collaborators

• University of Ljubljana: lead
• University of Ljubljana, Faculty of Medicine: collaborator

Study Sites (1)

Faculty of Sport, University of Ljubljana

Ljubljana, Ljubljana, 1000, Slovenia

Location

Related Publications (17)

• 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.

  PMID: 38053798 RESULT

• 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.

  PMID: 33764250 RESULT

• 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.

  PMID: 23370067 RESULT

• 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.

  PMID: 32789 RESULT

• 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.

  PMID: 29560326 RESULT

• 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.

  PMID: 28082179 RESULT

• 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.

  PMID: 28764143 RESULT

• 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.

  PMID: 30462568 RESULT

• 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.

  PMID: 26363684 RESULT

• 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.

  PMID: 30271611 RESULT

• 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.

  PMID: 15576744 RESULT

• 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.

  PMID: 39261538 RESULT

• 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.

  PMID: 34611407 RESULT

• Michaudet C, Edenfield KM, Nicolette GW, Carek PJ. Foot and Ankle Conditions: Pes Planus. FP Essent. 2018 Feb;465:18-23.

  PMID: 29381041 RESULT

• 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.

  PMID: 25598843 RESULT

• 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.

  PMID: 37949605 RESULT

• 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.

  PMID: 32412115 RESULT

MeSH Terms

Conditions

Flatfoot; Posterior Tibial Tendon Dysfunction

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Foot Diseases

Study Officials

• Rok Bavdek, PhD

  PRINCIPAL INVESTIGATOR

• Nejc Umek, MD PhD

  Institute of Anatomy, Faculty of Medicine, University of Ljubljana

  STUDY DIRECTOR

• Jure Jelenc, PhD

  Iskra Medical, d.o.o.

  STUDY DIRECTOR

Central Study Contacts

Rok Bavdek, PhD

CONTACT

0038641866285; rok.bavdek@gimkr.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The radiologist and the investigator responsible for testing the strength of the foot invertor muscles will be blinded to group allocation and intervention status. The radiologist will perform all ultrasound assessments of the foot invertor muscles and the height of the medial longitudinal arch, while the investigator will conduct standardized isometric strength measurements of the subtalar joint invertor muscles using a custom isometric dynamometer designed to measure torque along the subtalar axis. Both assessors will remain unaware of whether participants receive active rPMS or no stimulation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Faculty of Sport, University of Ljubljana

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD will be available 12 months after publication of the results and will remain available for 5 years.
• Access Criteria: Researchers will be able to request access to IPD. Access will be granted upon reasonable proposals which will be reviewed and approved by the study investigators. Only de-identified datasets will be shared. Data will be provided electronically.

Locations

SL (1)