Status:
NOT_YET_RECRUITING
Peripheral Magnetic Stimulation With Balance Training to Decrease Fall Risks in Diabetic Polyneuropathy
Lead Sponsor:
Queen Savang Vadhana Memorial Hospital, Thailand
Collaborating Sponsors:
Chulalongkorn University
Conditions:
Diabetic Polyneuropathy
Eligibility:
All Genders
50-75 years
Phase:
PHASE2
Brief Summary
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...
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 randoml...
Eligibility Criteria
Inclusion
- 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
- 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 30 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07000214
Start Date
June 1 2025
End Date
January 1 2026
Last Update
June 5 2025
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