About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Peripheral magnetic stimulation
- Balance training
- Sham stimulation
Treatment groups
Sponsors and collaborators
Queen Savang Vadhana Memorial Hospital, Thailand
Lead sponsor
Chulalongkorn University
Collaborator