Peripheral magnetic stimulation plus balance training to reduce falls in diabetic polyneuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, randomized, parallel-group proof-of-concept trial will enroll 40 people with diabetic polyneuropathy who have abnormal monofilament and one-leg-stance tests. Participants are randomly assigned to active repetitive peripheral magnetic stimulation (rPMS) delivered via the MAGBATA platform and racetrack coil during supervised balance exercises or to a sham stimulation control with identical procedures. The active protocol includes a tibialis anterior warm-up with 10 Hz rPMS and repeated one-leg stance cycles with brief 20 Hz rPMS pulses applied to the plantar surface at individualized intensities set relative to each participant's minimal contraction threshold. The intervention consists of eight supervised sessions given twice weekly and compares balance test outcomes and neuropathy severity between groups.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: KOMWUDH KONCHALARD, Doctor of Medicine
• Email: komwudh@gmail.com
• Phone: +6638320200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.