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

What this Trial Is About

Researchers are investigating whether peripheral magnetic stimulation (PMS) combined with balance training can reduce the risk of falls and decrease disease severity in patients with diabetic polyneuropathy. This proof-of-concept study uses the Magnetic and Balance Training Activator (MAGBATA), which delivers electromagnetic pulses to the feet while standing, aiming to improve sensory input, brain plasticity, and nerve regeneration. The trial is designed as a phase 2 randomized controlled study involving 40 patients with diabetic polyneuropathy aged 50 to 75 years. Participants will be randomly assigned to either an active intervention group receiving repetitive peripheral magnetic stimulation (rPMS) or a control group receiving sham stimulation. The active group will perform warm-up exercises involving ankle muscle contractions with 10 Hz rPMS, followed by one-leg stance exercises with 20 Hz rPMS applied to the foot. The control group will perform the same exercises but with sham stimulation that mimics the procedure without therapeutic intensity. The intervention consists of eight sessions over four weeks, with two sessions per week. During the study, assessments including the one-leg stance test (OLST), timed up and go test (TUGT), and short physical performance battery (SPPB) will be conducted before and after the 4-week intervention. Additionally, nerve conduction studies will be performed at baseline and after 8 weeks to evaluate disease severity. The study includes safety measures such as the use of a safety belt and walker assistance during balance exercises, and all tests are supervised by a physiotherapist and a blinded rehabilitation physician.

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