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Effects of vibrating insoles on improving peripheral sensation in people with diabetic peripheral neuropathy

An investigation of a smart insole, for the purpose of improving sensory response in people with diabetic peripheral neuropathy - SMARTSOLE

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15526470
Enrollment
23
Registered
2023-08-16
Start date
2020-10-25
Completion date
Unknown
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic peripheral neuropathy due to type 2 diabetes Nervous System Diseases

Interventions

The optimal vibration stimuli for improving balance in people with DPN remains unknown. Our study will thus explore the impact of different vibratory conditions on gait and balance in people with DPN.

Sponsors

Manchester Metropolitan University
Lead Sponsor

Eligibility

Sex/Gender
Male

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

MeasureTime 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

MeasureTime 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

Contacts

Public ContactGiorgio Orlando
g.orlando@mmu.ac.uk+44 (0)161 247 1358

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026