Effects of vibrating insoles on improving peripheral sensation in people with diabetic peripheral neuropathy
| ISRCTN | ISRCTN15526470 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15526470 |
| IRAS number | 273101 |
| Secondary identifying numbers | IRAS 273101 |
- Submission date
- 14/07/2023
- Registration date
- 16/08/2023
- Last edited
- 06/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Vibrating insoles have been shown to improve standing balance. People with diabetes are known to experience difficulties balancing, so an insole to improve balance control during walking may help prevent falls. This study investigates a range of types of vibration to establish which type of vibration gives the best improvement in balance. People who have been diagnosed with diabetes and have been identified as having some level of loss of sensation in the feet are eligible to participate in the study.
Who can participate?
Adult patients aged between 18 and 90 years old with a diagnosis of type 2 diabetes mellitus and moderate diabetic peripheral neuropathy plus the presence of at least one pedal pulse
What does the study involve?
Participants will be invited to visit the Gait and Biomechanics Laboratory at Manchester Metropolitan University in Manchester. During the study visit, they will undergo various tests related to movement and diabetes, including sensory assessment, questionnaires and a series of tests, including standing tests, walking and stair climbing.
What are the possible benefits and risks of participating?
There are no direct benefits from taking part in the current study. However, this study has been developed to inform a clinical trial where we will invite people to test a vibrating insole device in their daily life, to establish how well it benefits people by improving balance during daily activities.
Where is the study run from?
Manchester Metropolitan University (UK)
When is the study starting and how long is it expected to run for?
November 2018 to April 2022
Who is funding the study?
Horizon EUROPE SME Instrument grant. Project number: 879948.
Who is the main contact?
Prof Neil Reeves, n.d.reeves1@lancaster.ac.uk
Contact information
Scientific, Principal Investigator
Medical School, Faculty of Health and Medicine, Lancaster University, Health Innovation One Building
Lancaster
LA1 4YW
United Kingdom
 ORCID ID |
0000-0001-9213-4580 |
|---|---|
| n.d.reeves1@lancaster.ac.uk |
Public
Senior Research Associate
Manchester Metropolitan University
John Dalton Building, Chester Street
Manchester
M1 5GD
United Kingdom
| ORCID ID |
0000-0001-6721-8248 |
|---|---|
| Phone | +44 (0)161 247 1358 |
| g.orlando@mmu.ac.uk |
Study information
| Study design | Single-blind randomized cross-sectional crossover-design intervention trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Prevention, Quality of life, Efficacy |
| Participant information sheet | 43958_PIS_v01.3_15Oct2020.pdf |
| Scientific title | An investigation of a smart insole, for the purpose of improving sensory response in people with diabetic peripheral neuropathy - SMARTSOLE |
| Study acronym | SMARTSOLE |
| Study hypothesis | The optimal vibrational type for improving sensory perception and balance control in people with diabetic peripheral neuropathy (DPN) remains unknown. The current study will assess different types of vibrational stimuli provided by a vibrating insole device, to determine the conditions providing optimal improvement in sensory perception and balance control during dynamic and static tasks in diabetic patients with DPN. |
| Ethics approval(s) |
1. Approved 05/11/2020, North West - Greater Manchester East Research Ethics Committee (3rd Floor, Barlow House 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; None available; gmeast.rec@hra.nhs.uk), ref: 20/NW/0372 2. Approved 16/10/2020, MHRA (10 South Colonnade Canary Wharf, London, E14 4PU, United Kingdom; +44 (0)20 3080 6521; agnes.botchey@mhra.gov.uk), ref: CI/2020/0026 |
| Condition | Diabetic peripheral neuropathy due to type 2 diabetes |
| Intervention | 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. Every participant will attend a one-day session at the biomechanics lab of the Manchester Metropolitan University where he will wear a vibrating insoles system. Participants will be randomly exposed to seven different vibratory stimuli and one control condition (without vibration) for a total of eight conditions. The vibratory conditions will vary based on different parameters, including frequency, type of activation, the addition or otherwise of white noise, and the location of vibration. The order of the eight conditions will be determined by a random number generator. The insole device will be inserted in standardised footwear (furnished to the participants) and will deliver vibration for the duration of the functional tasks, including standing tests, walking and stair negotiation. Participants will have a rest time (10 minutes) and a period of acclimatisation (10 minutes) to each new vibration setting. Every session will require approximately 5 hours. Gait kinematics and balance data will be collected using a 3D Motion capture system and force platforms after each condition. A highly skilled researcher on diabetic foot and biomechanics will manage and monitor the vibratory intervention and collect biomechanical data. The researcher will be trained in the use of the vibrating insole system and 3D Motion capture system. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Path feel vibrating insole system, developed by Walk With Path (Denmark). |
| Primary outcome measure | 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 | 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 |
| Overall study start date | 10/11/2018 |
| Overall study end date | 30/04/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | Male |
| Target number of participants | 23 |
| Total final enrolment | 22 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 25/10/2020 |
| Recruitment end date | 01/12/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Oxford Road
Manchester
M13 9WL
United Kingdom
Manchester
OL6 9RW
United Kingdom
Sponsor information
University/education
Faculty of Science and Engineering
John Dalton Building
Oxford Road
Manchester
M1 5GD
England
United Kingdom
| Phone | +44 (0)161 247 2000 |
|---|---|
| n.reeves@mmu.ac.uk | |
| Website | http://www2.mmu.ac.uk/ |
"ROR" |
https://ror.org/02hstj355 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Horizon Europe, Horizon Europe Programme, Framework Programme, Horizon Europe, EU Framework Programme, Horizon
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high impact peer reviewed journal |
| IPD sharing plan | The dataset generated during and/or analysed during the current study is not expected to be made available due to commercial sensitivity. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 01.3 | 15/10/2020 | 15/08/2023 | No | Yes |
| Results article | 01/06/2024 | 06/06/2024 | Yes | No |
Additional files
Editorial Notes
06/02/2025: The PI contact details were updated.
06/06/2024: Publication reference and total final enrolment added.
15/07/2023: Tria's existence confirmed by the Health Research Authority North West - Greater Manchester East Research Ethics Committee (UK).
