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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
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 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
Zdravstveni dom Koper
Koper, Urban Municipality of Koper, Slovenia
Change From Baseline in Timed Up and Go Completion Time
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.
Time frame: Baseline and after 2 weeks of intervention (after 12 sessions)
Change From Baseline in Hallux Grip Force Assessed With the Enhanced Paper Grip Test
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.
Time frame: Baseline and after 2 weeks of intervention (after 12 sessions)
Change From Baseline in Center-of-Pressure Sway Velocity
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.
Time frame: Baseline and after 2 weeks of intervention (after 12 sessions)
Change From Baseline in Semmes-Weinstein Monofilament Total Score
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
Time frame: Baseline and after 2 weeks of intervention (after 12 sessions)
Change From Baseline in Vibration Perception Threshold
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.
Time frame: Baseline and after 2 weeks of intervention (after 12 sessions)
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