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

March 26, 2026 updated by: Komwudh Konchalard, Queen Savang Vadhana Memorial Hospital, Thailand

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This single-center randomized controlled trial will use a two-group parallel design and include 40 patients with diabetic polyneuropathy who meet the eligibility criteria. Participants will be randomly assigned to either the active intervention group or the control group.

The active intervention group will receive a warm-up exercise consisting of 25 repetitions of ankle dorsiflexion with concurrent 10 Hz rPMS applied to the tibialis anterior of each leg. 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 and consists of 3 seconds of 20 Hz rPMS applied to the plantar surface of the foot while the participant stands on one leg, followed by 12 seconds of rest during which the participant stands on both legs. The same sequence will then be repeated for the other leg. Stimulation intensity will be determined prior to the warm-up. The coil will be placed over the tibialis anterior to determine the minimal contraction threshold (MCT), defined as the lowest intensity that produces a visible contraction. The stimulation intensity will be set at 110% of the MCT for the warm-up exercise and 120% for the treatment during balance exercises.

The control group will receive the same procedure, but with sham stimulation during both the warm-up and one-leg stance phases.

The intervention will consist of 8 sessions, conducted twice per week with at least one day of rest between sessions. Outcome assessments include one-leg stance test (OLST) with eyes open, timed up and go test (TUGT), and short physical performance battery (SPPB); these assessments will be conducted at baseline and after the 4-week intervention. Additionally, a rehabilitation physician, blinded to group allocation, will perform electrophysiologic studies at baseline and week 8 to assess disease severity. These studies will include bilateral measurements of sural nerve amplitude and conduction velocity, tibial compound motor action potential (CMAP) amplitude and conduction velocity, and tibial F-wave latency.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: KOMWUDH KONCHALARD, Doctor of Medicine
  • Phone Number: 10711 +6638320200
  • Email: komwudh@gmail.com

Study Locations

  • Thailand
    • Changwat Chon Buri
      • Chon Buri, Changwat Chon Buri, Thailand, 20110
        • Recruiting
        • Queen Savang Vadhana Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peripheral magnetic stimulation with balance training (rPMS-BT)
The participants will undergo a warm-up exercise involving ankle dorsiflexion, with concurrent rPMS applied to the tibialis anterior of each leg. Following the warm-up, participants will stand on the MAGBATA platform and perform one-leg stance exercises while rPMS is applied to the plantar surface of the foot. This procedure will be repeated for the other leg.
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.
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.
Sham Comparator: Sham stimulation with balance training (Sham-BT)
The sham comparator group will receive the same procedure as the interventional group, but with sham stimulation during both the warm-up and 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
One-leg standing balance test (OLST)
Time Frame: From enrollment to the end of treatment (week 4).
Participants stand on the floor with their eyes open and arms relaxed at the sides of the body. They are instructed to lift the opposite foot off the floor, flex the knee to 90 degrees, and position the lifted foot behind the body, maintaining balance on the tested leg for as long as possible. The assessor begins timing when the participant's foot leaves the floor and stops timing if the participant sways, extends either arm to maintain balance, or successfully holds the position for 30 seconds. The test is then repeated on the opposite leg. The durations from both legs are summed and reported in seconds.
From enrollment to the end of treatment (week 4).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed up and go test (TUGT)
Time Frame: From enrollment to the end of treatment (week 4).
Participants sit on a chair with a seat height between 44 and 47 cm, with their back resting against the backrest. The assessor instructs them to walk to a marked point 3 meters straight ahead and then return to sit on the chair. Timing begins when the participant's back leaves the backrest and stops when they return to the chair and their back touches the backrest. The test is performed twice, and the best performance with shorter duration in seconds, will be recorded.
From enrollment to the end of treatment (week 4).
Short physical performance battery (SPPB)
Time Frame: From enrollment to the end of treatment (week 4).

The Short Physical Performance Battery (SPPB) includes three subtests: gait speed, chair stand, and balance. Each test scored from 0 to 4and are summed up to give a total score ranging from 0 to 12.

Gait speed: Participants are instructed to walk at their normal pace over a distance of 4 meters. The assessor times each trial from the start of walking until the participant reaches the end.

Chair stand test: Participants are instructed to rise from a seated position to standing five times, keeping their arms crossed at chest level. The assessor starts timing when the participant's buttocks leave the chair and stops when they return to the seat after the fifth stand.

Balance test on both feet: Participants first stand with feet together for 10 seconds to earn 1 point, then in semi-tandem with the heel beside the mid-foot for 10 seconds to earn another point, and finally in full tandem for 10 seconds to earn 2 points.
From enrollment to the end of treatment (week 4).
Nerve conduction study
Time Frame: From enrollment to week 8.
Nerve conduction study will be performed using the electrodiagnostic unit, Sierra Summit (Cadwell, Kennewick, WA, USA). Bilateral sural and tibial nerves will be tested, measuring parameters including sensory nerve action potential (SNAP) amplitude of the sural nerves, compound motor action potential (CMAP) amplitudes of the tibial nerves, F-wave latency of the tibial nerves.
From enrollment to week 8.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Collaborators

Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

May 29, 2025

First Submitted That Met QC Criteria

May 29, 2025

First Posted (Actual)

June 2, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 010/2568

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual-level data related to the primary and secondary outcomes of all participants will be shared.

IPD Sharing Time Frame

Beginning 6 months after publication; for 2 years.

IPD Sharing Access Criteria

IPD will be shared upon reasonable request by email with researchers conducting similar studies or performing meta-analyses. The process will require approval by the Institutional Review Board (IRB) and may also require a data use agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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