Diabetic Peripheral Neuropathy
Conditions
Keywords
functional magnetic stimulation, peripheral magnetic stimulation, plantar sensation, foot strength, diabetic peripheral neuropathy, vibration perception
Brief summary
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.
Interventions
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
DEVICESham Functional Magnetic Stimulation
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
Sponsors
University of Primorska
Zdravstevni dom Koper
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants in the sham group underwent the same positioning, session duration, and treatment procedures as participants receiving active stimulation. A metal plate was positioned between the support plate and magnetic stimulation head to shield or substantially attenuate the magnetic field while preserving the external appearance and procedural experience of treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Timed Up and Go Completion Time | 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. |
| Change From Baseline in Hallux Grip Force Assessed With the Enhanced Paper Grip Test | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Center-of-Pressure Sway Velocity | 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. |
| Change From Baseline in Semmes-Weinstein Monofilament Total Score | 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 |
| Change From Baseline in Vibration Perception Threshold | 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. |
Countries
Slovenia
Outcome results
None listed