TCTR20230530003
Completed
Phase 4
Investigating the effectiveness of using vibratory stimulus with noise and SR compared with using vibratory stimulus without noise and SR in tactile stimulation in type 2 diabetic patients with peripheral neuropathy
Institute of Automation0 sites60 target enrollmentMay 30, 2023
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Type 2 diabetic patients with peripheral neuropathy
- Sponsor
- Institute of Automation
- Enrollment
- 60
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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