Peripheral Magnetic Stimulation With Balance Training to Decrease Fall Risks in Diabetic Polyneuropathy

Summary

This study aims to determine whether peripheral magnetic stimulation (PMS) during balance training in patients with diabetic polyneuropathy reduces fall risk, as measured by balance tests, and lessens disease severity compared to balance training with sham stimulation. This proof-of-concept study will utilize the Magnetic and Balance Training Activator (MAGBATA), a platform mounted with a magnetic stimulation coil that delivers electromagnetic pulses directly to the plantar surfaces of the feet while patients stand. A racetrack coil (RT-120), connected to the MagPro X100 magnetic stimulator with MagOption (MagVenture, Farum, Denmark), will be used. Parameters for the repetitive peripheral magnetic stimulation (rPMS) protocol will be configured to facilitate sensory input, enhance brain plasticity, and promote axonal regeneration.

Eligibility

Inclusion Criteria:

* Diabetes mellitus type 2 with any symptoms of distal polyneuropathy, including numbness, paresthesia, dysesthesia, or lower leg weakness.
* Abnormal 10g monofilament test.
* Abnormal one-leg stance test (OLST) with eyes open.

Exclusion Criteria:

* Chronic foot ulceration.
* Severe leg or foot pain not controllable with medications or other interventions.
* Significant foot deformity, including severe pes cavus, severe claw toe, or toe amputation.
* Body mass index (BMI) over 35 kg/m².
* Visual acuity less than 20/100 after correction with glasses or contact lenses.
* Postural instability or coordination disorders resulting from musculoskeletal, vestibular, or central nervous system conditions.
* Symptoms such as confusion, drowsiness, dizziness, or a high risk of falls due to any disease or recent medication changes within a two-week period.
* Presence of cardiac pacemaker, knee prosthesis, or metal implants in the lower legs.
* Inability to walk or stand for at least 5 minutes.
* Inability to understand, comprehend, or follow instructions required to conduct the study, or to provide informed consent.

Conditions2

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