Investigation of the effectiveness of the developed vibrating FO combined with a noise-based technique and SR for tactile stimulation in type 2 diabetic patients with mild to moderate peripheral neuropathy

Institute of Automation0 sites55 target enrollmentJune 1, 2023

Overview

No summary available.

Registry

who.int

Start Date

June 1, 2023

End Date

November 30, 2023

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Institute of Automation

•(1\) Diagnosis of type 2 diabetes mellitus.
•(2\) Diagnosis of peripheral neuropathy on the feet, and there is numbness all over the soles of the foot.
•(3\) No muscle weakness in lower extremity and muscle strength at bleast 4, grading by the Medical Research Council (MRC).
•(4\) No skin problems in the feet, such as ulcers, wounds, blisters, abrasions, calluses, skin irritations, open skin areas, or burns, etc. in the area of the foot and lower leg, and no skin diseases caused by viruses, fungi, or bacteria.
•(5\) Foot structure as flat feet or high arches can participate in these research studies.
•(6\) Subjects must have ability to perceive vibrational stimulation.
•(7\) Subjects have sufficient cognitive and language abilities to follow instructions, e.g., no dementia, no pronounced hearing loss.
•(8\) Subjects have ability to sit for at least 60 minutes.
•(9\) Vital signs, neurological signs and medical conditions are stable.

•(1\) Musculoskeletal problems such as severe pain in any joints of the foot.
•(2\) Contracture of the ankle, or foot joint that hindered using the vibrating Foot Orthoses.
•(3\) Cognitive impairment (Thai Mental State Examination Scores less than 23\).
•(4\) Subjects have other diseases that are complicated by diabetes, such as epilepsy, brain disorders, and seizure.
•(5\) Subjects have a medical condition that may be affected or affected by participating in the research project.
•(6\) Allergy to the vibrating FO materials.