Investigating the efficacy of the developed vibrating FO combined with a noise-based technique and SR to stimulate tactile sensation in type 2 diabetic patients with peripheral neuropathy

Phase 2

Completed

• Conditions: Diabetes; Type 2 diabetic patients with peripheral neuropathy; Peripheral Neuropathy; Tactile Sensation; Foot Orthoses; Vibrating; Stochastic Resonance

• Registration Number: TCTR20230530001
• Lead Sponsor: Institute of Automation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-30
• Study Completion: 2023-10-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

(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.

Exclusion Criteria

(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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified