Can a smart insole fit into standard treatment pathways?
| ISRCTN | ISRCTN51549193 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51549193 |
| Sponsor | University of Southampton |
| Funder | Investigator initiated and funded |
- Submission date
- 06/01/2026
- Registration date
- 08/01/2026
- Last edited
- 08/01/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study is about new “smart” textiles that have electronics built into them, (an emerging field know as e-textiles) such as smart clothing and wearable health devices. Although these products can work well as early prototypes, it can be difficult to make them reliably at larger scale and to make sure they keep working properly in everyday life outside the lab. Most existing research is based on small studies or controlled tests, which often have only a few samples, so we need more information about how these technologies perform in the real world.
To address this, this study will collect feedback and practical data from a range of people using the Smart Insoles in their normal daily routines. What we learn will help improve future smart textile products and guide future research
Who can participate?
Adults aged 18 years or over who have full physical capability and do not have any documented health conditions or physical impairments.
What does the study involve?
Participants will be provided with a pair of Southampton Smart Insoles that contain miniature electronics. They will be asked to wear the insoles as you would any normal insole, as part of their usual daily routines, for up to 5 weeks. The insoles will be provided with minimal instructions to encourage natural, real-world use. During the wear period, they will complete a simple wear diary. They may be asked to take a straightforward sensor reading at the start and end of the wear period using a standard smartphone. These readings are non-invasive and do not include identifiable information. After the wear period, they will return the insoles to the investigator for analysis. They will be invited to a short Microsoft Teams call (around 15–20 minutes) to share feedback via a questionnaire. We will also collect basic demographic information (such as age range, gender, and occupation) to help interpret the findings.
What are the possible benefits and risks of participating?
Their participation is vital in helping improve the understanding of how smart insoles, and E-textiles as a whole, perform in real-world conditions. Their feedback will help improve future smart insole and E-textile designs and support research at Southampton. There are no foreseeable disadvantages of taking part in this study - the usual 'easing in' period of using an orthotic will apply, but no additional risks will be introduced. Participants are free to stop wearing them at any time if they experience discomfort, or for any other reason. Data privacy risks are minimised by secure handling of study information. The electronics in the insoles are designed to be lightweight and do not come into direct contact with the skin. The sensor data collected by the insoles is non-identifiable and is limited to temperature and basic magnetic (magnetometer) readings.
Where is the study run from?
University of Southampton (UK)
When is the study starting and how long is it expected to run for?
November 2025 to March 2026
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Michael John Lynch, m.j.lynch@soton.ac.uk
Full contact details will be provided in the Participant Information Sheet
Contact information
Principal investigator, Public
9 Hadfield Grove
Leigh
WN7 2ET
United Kingdom
 ORCID ID |
0009-0009-7248-2874 |
|---|---|
| Phone | +44 (0)7511479495 |
| mjl2g23@soton.ac.uk |
Scientific
Warrington and Halton Teaching
Hospitals
NHS Foundation Trust
Warrington
WA5 1QG
United Kingdom
| ORCID ID |
0009-0009-8804-051X |
|---|---|
| Phone | +44 (0)7436872425 |
| kate.lynch4@nhs.net |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Active | |
| Assignment | Factorial | |
| Purpose | Device feasibility, Health services research, Supportive care, Treatment | |
| Scientific title | Scalable manufacturing processes for fully integrated e-textiles: smart insole | |
| Study objectives | The objectives of this study are centred on obtaining real-world feedback from participants engaged in wearing a prototype E-textile, specifically focusing on a Southampton-developed Smart Insole. This information aims to investigate the non-inferiority of comfort of smart insoles when compared with standard practice. | |
| Ethics approval(s) |
Approved 08/10/2025, University of Southampton Research Ethics and Governance Office (University of Southampton, University Road, Southampton, SO17 1BJ, United Kingdom; N/A; risethic@soton.ac.uk), ref: 104938.A1 | |
| Health condition(s) or problem(s) studied | Patient compliance to orthotic intervention | |
| Intervention | All possible interventions were entered into an online randomisation tool, which generated a random combination of interventions: 1. Standard simple insoles 2. Simple insoles with flexible circuit board, but no componentry 3. Simple insoles with flexible circuit board and added componentry Each participant will be asked to wear their randomly assigned insoles for a period of 4 weeks. They will be provided with a wear diary for this time period and asked to wear the insoles for as much as is reasonable. | |
| Intervention type | Device | |
| Phase | Not Applicable | |
| Drug / device / biological / vaccine name(s) | Smart simple insoles | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) | ||
| Completion date | 31/03/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | 1. Over the age of 18 years 2. Can walk 20 metres unaided 3. Functional sensation of foot and ankle 4. No current foot ulceration |
| Key exclusion criteria | 1. Diabetic population 2. People with vascular neuropathy 3. Active foot ulceration 4. Pregnant women 5. Vulnerable groups 6. Those under the age of 18 years |
| Date of first enrolment | 24/11/2025 |
| Date of final enrolment | 27/02/2026 |
Locations
Countries of recruitment
- Ireland
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
07/01/2026: Study's existence confirmed by the University of Southampton Research Ethics and Governance Office.
