Diabetic peripheral neuropathy due to type 2 diabetes Nervous System Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of type 2 diabetes mellitus 2. Aged >18 years 3. Presence of at least one pedal pulse 4. Presence of moderate diabetic peripheral neuropathy defined by a vibration perception threshold > 15V 5. Ability to walk unaided for 30 steps 6. Able to understand all of the study requirements 7. Fit shoe size UK 8-12
Exclusion criteria
Exclusion criteria: 1. Active foot ulcer 2. NHS prescription footwear 3. Lower limb amputation (anything more than amputation of two lesser toes) 4. Severe deformity due to Charcot Neuroarthropathy 5. Major foot deformities, including diabetes and non-diabetes-related deformities 6. Dementia or other cognitive impairment 7. Significant cardiopulmonary or other systemic disease limiting the patient’s ability to walk 30 steps 8. Person with bodyweight greater than 100kg (due to insole device limitations) 9. Use of a pacemaker 10. Inability to understand verbal and written information in English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postural sway during standing, walking and stair negotiation are measured using a 3D motion capture system and force platforms before and after each vibration condition | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Gait kinematics and kinetics are measured using a 3D motion capture system and force platforms before and after each vibration condition 2. Muscle activation using surface electromyography (sEMG) before and after each vibration condition | — |
Countries
England, United Kingdom