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Completed

NCT Number: NCT07818993

Effects of Functional Magnetic Stimulation in Sensory and Motor Function in Diabethic Neuropathy

This study evaluated whether a 2-week course of functional magnetic stimulation applied to the plantar region of the foot could improve sensory function, foot muscle force, postural control, and functional mobility in adults with type 2 diabetes mellitus and diabetic peripheral neuropathy. Participants were assigned to active functional magnetic stimulation or sham stimulation. The study hypothesis was that repeated functional magnetic stimulation would improve sensory and motor function and lead to better functional performance compared with sham stimulation.

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Key information

Conditions

Diabetic Peripheral Neuropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zdravstveni dom Koper

Koper, Urban Municipality of Koper, 6000, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults with type 2 diabetes mellitus and diabetic peripheral polyneuropathy documented in their medical records
  • Ability to walk independently with or without an assistive device
  • Ability to understand and follow study procedures

Exclusion criteria

  • Conditions that could independently affect balance or foot function
  • Contraindications to magnetic stimulation
  • Active foot ulceration
  • Recent lower-limb injury or surgery
  • Severe neurological or musculoskeletal disease unrelated to diabetic peripheral neuropathy
  • Cognitive impairment preventing valid participation

Treatment and study plan

Functional Magnetic Stimulation

Device

Pulsed magnetic stimulation was delivered to the plantar region of the foot using the FMS Stym device (Iskra Medical, Slovenia). Participants completed 12 sessions over 2 weeks, each lasting 20 minute

Sham Functional Magnetic Stimulation

Device

Sham treatment reproduced the positioning, appearance, schedule, and duration of active functional magnetic stimulation while a metal plate substantially attenuated the magnetic field reaching the foo

Primary outcomes

  1. Change From Baseline in Timed Up and Go Completion Time

    Time frame: Baseline and after 2 weeks of intervention (after 12 sessions)

    Participants rose from a chair, walked 3.6 m, turned, walked back to the chair, and sat down. Completion time was recorded in seconds. Lower values indicate better functional mobility.

  2. Change From Baseline in Hallux Grip Force Assessed With the Enhanced Paper Grip Test

    Time frame: Baseline and after 2 weeks of intervention (after 12 sessions)

    Hallux grip force was measured in Newtons using the Enhanced Paper Grip Test. Three measurements were performed for each foot, and the outcome was the average across both feet and three trials. Higher values indicate greater foot grip force.

Secondary outcomes

  1. Change From Baseline in Center-of-Pressure Sway Velocity

    Time frame: Baseline and after 2 weeks of intervention (after 12 sessions)

    Postural sway was assessed during three 30-second barefoot parallel-stance trials on a force platform. Global center-of-pressure sway velocity was expressed in mm/s and averaged across the three trials. Higher values indicate greater postural sway.

  2. Change From Baseline in Semmes-Weinstein Monofilament Total Score

    Time frame: Baseline and after 2 weeks of intervention (after 12 sessions)

    Tactile pressure perception was assessed bilaterally using a 10-g Semmes-Weinstein monofilament at five anatomical sites on each foot. Each site was tested three times. Perceived stimuli were scored 1 and unperceived stimuli 0, giving a total score from 0 to 30. Higher scores indicate better tactile pressure perception

  3. Change From Baseline in Vibration Perception Threshold

    Time frame: Baseline and after 2 weeks of intervention (after 12 sessions)

    Vibration perception threshold was assessed bilaterally at five foot locations using a 100-Hz biothesiometer with an output range of 0-50 V. Lower thresholds indicate better vibration perception. Failure to perceive the maximum 50-V stimulus was classified as an undetected measurement.

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Sponsors and collaborators

Lead sponsor

University of Primorska

Other

Collaborators

  • Zdravstevni dom Koper

Registry information

Official study title

Effects of Functional Magnetic Stimulation on Sensory, Motor, and Functional Outcomes in Individuals With Diabetic Peripheral Neuropathy: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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