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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

January 31, 2026

Conditions
Diabetic Polyneuropathy
Interventions
DEVICE

Peripheral magnetic stimulation

During the warm-up exercise, 10-Hz rPMS will be applied to the tibialis anterior with an on-time of 4 seconds (40 pulses per train), followed by an off-time (inter-train interval) of 8 seconds, for a total of 25 trains for each leg. During the one-leg stance exercise, 20-Hz rPMS will be applied to the plantar surface of the standing foot for 3 seconds of on-time (60 pulses per train), followed by 12 seconds of off-time, for a total of 20 trains for each foot. Stimulation intensity will be set at 110% of MCT for the warm-up exercise and 120% of MCT for the treatment during the one-leg stance exercise.

BEHAVIORAL

Balance training

The warm-up exercise consists of 25 repetitions of 4-second active contractions of the tibialis anterior muscle in each leg while seated. Following the warm-up, participants will stand on the MAGBATA platform and perform 20 cycles of one-leg stance exercises under the supervision of a physiotherapist. Each cycle lasts 20 seconds, consisting of 3 seconds of one-leg stance while the other leg is raised about 10 centimeters above the ground, followed by 12 seconds of rest during which the participant stands on both legs, keeping their arms close to their body and hands free. The same sequence will then be repeated for the other leg. To prevent falling, participants will wear a safety belt around the waist, allowing the physiotherapist to assist if they lose balance. Participants will also be allowed to grab the walker positioned in front of them to prevent falling.

OTHER

Sham stimulation

During the warm-up exercise, the stimulation coil will be placed perpendicular to the participants' shin. The same parameter settings will be used, except for the intensity, which will be set at 30% of the maximum stimulator output (MSO). Sham stimulation during the one-leg stance exercise is achieved by disconnecting the coil mounted in MAGBATA and placing an alternate coil, connected to the magnetic stimulator placed behind the participants so they can hear a clicking pattern similar to that of the rPMS-BT arm.

All Listed Sponsors
collaborator

Chulalongkorn University

OTHER

lead

Queen Savang Vadhana Memorial Hospital, Thailand

OTHER