Effects of vibrating insoles on improving peripheral sensation in people with diabetic peripheral neuropathy
- Conditions
- Diabetic peripheral neuropathy due to type 2 diabetesNervous System Diseases
- Registration Number
- ISRCTN15526470
- Lead Sponsor
- Manchester Metropolitan University
- Brief Summary
2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38536962/ (added 06/06/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 22
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1. Gait kinematics and kinetics are measured using a 3D motion capture system and force platforms before and after each vibration condition<br>2. Muscle activation using surface electromyography (sEMG) before and after each vibration condition<br>